Trial | Phase | Enrollment | Study Type | Start Date | Status |
Comparison of Anaesthetic Effectiveness of Different Volumes of Articaine for Inferior Alveolar Nerve Block in Molar Teeth With Symptomatic Irreversible Pulpitis [NCT05840913] | Phase 2 | 78 participants (Anticipated) | Interventional | 2023-04-30 | Recruiting |
Make up for the Epinephrine Autoinjector: Effect on Its Use by Untrained Users [NCT01217138] | Phase 4 | 164 participants (Actual) | Interventional | 2009-06-30 | Completed |
Bupivacaine in the Treatment of Postoperative Pain of Impacted Third Molar Extraction. A Randomized Clinical Trial. [NCT03950700] | Phase 4 | 40 participants (Actual) | Interventional | 2019-06-01 | Completed |
Effect of Papillary Epinephrine Spraying for the Prevention of Post-ERCP Pancreatitis in Patients Received Sublingual Nitroglycerin: A Multi-center, Single-blind, Randomized Controlled Trial [NCT03756116] | | 2,000 participants (Anticipated) | Interventional | 2018-10-01 | Recruiting |
Saline Injection - Assisted Anesthesia in Eyelid Surgery [NCT01239498] | Phase 4 | 60 participants (Anticipated) | Interventional | 2010-11-30 | Recruiting |
Double-blind Comparison of Intrapleural Bupivacaine and Saline for Ipsilateral Shoulder Pain After Thoracotomy in Patients Receiving Thoracic Epidural Analgesia [NCT03862404] | Phase 4 | 42 participants (Actual) | Interventional | 2017-07-01 | Completed |
Bupivacaine Versus Lidocaine Infiltration for Postoperative Pain in Thyroid Surgery: A Randomized Controlled Trial [NCT04427904] | Phase 2 | 210 participants (Anticipated) | Interventional | 2022-06-01 | Recruiting |
Endoscopic Injection of Autologous Blood Versus Diluted Epinephrine for Control of Actively Bleeding Gastroduodenal Ulcers [NCT01560702] | | 100 participants (Actual) | Interventional | 2012-03-31 | Completed |
Application of Iced Normal Saline Combined With Cocktail Perfusion in Total Knee Arthroplasty: Randomized Controlled Trial [NCT05204056] | | 60 participants (Actual) | Interventional | 2018-03-02 | Completed |
Post-cesarean Analgesia With Epidural Morphine Following Epidural 2-chloroprocaine [NCT04369950] | Phase 4 | 44 participants (Actual) | Interventional | 2020-05-11 | Completed |
Effect of a Vibration System on Pain Reduction During Injection of Local Dental Anaesthesia in Children: a Randomized Controlled Clinical Trial [NCT03953001] | | 51 participants (Actual) | Interventional | 2018-01-01 | Completed |
Ilioinguinal/Iliohypogastric vs. Quadratus Lumborum Nerve Blockade for Elective Open Inguinal Herniorrhaphy [NCT03007966] | Phase 2 | 60 participants (Actual) | Interventional | 2017-01-30 | Completed |
Local Effects of Epinephrine on Lactate, Glucose, Lipid and Protein Metabolism in Bilaterally Perfused Human Legs [NCT01116609] | | 10 participants (Actual) | Interventional | 2004-10-31 | Completed |
Comparison of Perfusion Index, T Wave Amplitude, Systolic Blood Pressure and Heart Rate as an Indicator for Detecting Intravascular Injection of Epinephrine Containing Test Dose During Operation in Anesthetized Adults [NCT01131741] | | 50 participants (Anticipated) | Interventional | 2010-05-31 | Recruiting |
Hemostatic and Hemodynamic Effects of Intranasal Injection Compared to Topical Administration of Epinephrin in Endoscopic Sinus Surgery [NCT01075581] | | 50 participants (Anticipated) | Interventional | 2010-04-30 | Not yet recruiting |
A Two-Period Crossover Study to Compare the Systemic Exposure to Trans-Capsaicin and Cis-Capsaicin From an Intra-Articular Injection of CNTX-4975-05 (Trans-capsaicin for Injection) and Topical 8% Capsaicin Patch (Qutenza®) in Subjects With Painful Knee Os [NCT03576508] | Phase 1 | 16 participants (Actual) | Interventional | 2018-06-25 | Completed |
ED50 and ED95 of Intrathecal Bupivacaine With or Without Epinephrine for Total Knee Replacement Arthroplasty [NCT01264575] | | 162 participants (Actual) | Interventional | 2009-12-31 | Completed |
Study of Intracameral Adrenaline for Pupil Dilation Without Topical Mydriatics in Refractive Cataract Surgery [NCT01264653] | | 60 participants (Actual) | Interventional | 2010-12-31 | Completed |
Combined Subconjunctival Atropine and Intracameral Epinephrine Injection for Pupil Dilation in Phacoemulsification Under Peribulbar Anesthesia. [NCT03638726] | Phase 4 | 40 participants (Anticipated) | Interventional | 2018-09-28 | Recruiting |
Pretreatment of Lacerations With Topical LET (Lidocaine-Epinephrine-Tetracaine) Reduces Pain During Tissue Adhesive Repair in Children: Double-blind, Randomized, Controlled Trial of Efficacy [NCT01202487] | Phase 2 | 222 participants (Actual) | Interventional | 2011-04-30 | Completed |
Antecubital Versus Femoral Approach for Adrenal Venous Sampling: A Randomised Controlled Trial [NCT06029803] | | 154 participants (Anticipated) | Interventional | 2022-04-01 | Recruiting |
Randomized Control Trial of Ultrasound-Guided Erector Spinae Block Versus Shoulder Periarticular Anesthetic Infiltration for Pain Control After Arthroscopic Shoulder Surgery [NCT03691922] | | 62 participants (Actual) | Interventional | 2019-07-06 | Completed |
Analgesic Efficacy of Liposomal Bupivacaine in Total Knee Arthroplasty [NCT02426164] | Phase 4 | 0 participants (Actual) | Interventional | 2015-06-30 | Withdrawn(stopped due to Could not receive facility approval) |
Randomized, Placebo-controlled Trial of Erector Spinae Plane Blocks (ESPB) for Perioperative Pain Management for Minimally Invasive (MIS) Lumbar Spine Surgery [NCT05029726] | Phase 4 | 125 participants (Anticipated) | Interventional | 2022-02-01 | Recruiting |
Hemodynamic Stability of Bupivacaine With and Without Adrenaline for Paracervical Block for Cervical Conization During General Anesthesia: A Randomized Controlled Double Blinded Study [NCT02368054] | Phase 4 | 34 participants (Actual) | Interventional | 2015-05-31 | Completed |
Pilot Study: Comparison of Buffered 1% vs. Unbuffered 2% Lidocaine in Pediatric Subjects; Clinical Outcomes [NCT03562481] | Phase 4 | 26 participants (Actual) | Interventional | 2018-07-24 | Completed |
Bioavailability Comparison of Epinephrine Following a Single Nasal Dose of Microspheres Powder With Epinephrine Intramuscular Injection in Adults With Seasonal Allergic Rhinitis With and Without Nasal Allergen Challenge [NCT04696822] | Phase 1 | 12 participants (Actual) | Interventional | 2020-11-01 | Completed |
Can Trajectory Nor-epinephrine Infiltration Reduce Blood Loss During Percutaneous Nephrolithotomy?: A Double-blind Randomized Placebo Controlled Study. [NCT05035303] | | 140 participants (Actual) | Interventional | 2020-03-10 | Completed |
Role of Low Dose Epinephrine Boluses For Acute Hypotension in The Pediatrics ICU [NCT03671070] | | 50 participants (Anticipated) | Interventional | 2019-01-01 | Not yet recruiting |
Randomized Trial Comparing Bupivacaine vs Lipossomic Extended Release Bupivacaine for Postoperative Pain Control After Minimally Invasive Thoracic Surgery [NCT03560362] | Phase 1/Phase 2 | 50 participants (Anticipated) | Interventional | 2015-07-09 | Recruiting |
Towards Cost-effective Management of Patients With Hypertension Due to Primary Aldosteronism: Adrenal Vein Sampling or Ct-scan? [NCT01096654] | Phase 3 | 200 participants (Actual) | Interventional | 2010-07-31 | Completed |
The Application of Recombinant Human Hyaluronidase is Effective for the Use of Local Blocks for Eyelid Surgery [NCT02059694] | | 0 participants (Actual) | Interventional | | Withdrawn |
Optimizing the Use of Vasopressor After Coronary Reperfusion in Cardiogenic Shock Secondary to Myocardial Infarction. Pathophysiological Study Comparing the Efficacy and Cardio-circulatory Tolerability of Epinephrine and Norepinephrine [NCT01367743] | Phase 4 | 58 participants (Actual) | Interventional | 2011-09-30 | Completed |
Effect of Dexamethasone and Epinephrine on the Duration of Sciatic Nerve Blocks With Ropivacaine in Ankle and Foot Surgery [NCT02104778] | | 90 participants (Anticipated) | Interventional | 2014-04-30 | Recruiting |
Randomized Clinical Trial to Verify the Effectiveness of Topical Aminocaproic Acid in the Prevention of Post-exodontic Bleeding in Patients on Anticoagulants [NCT02238288] | Phase 4 | 154 participants (Anticipated) | Interventional | 2013-12-31 | Enrolling by invitation |
Laparoscopically Guided Rectus Sheath Block in Pediatric Appendicitis - a Randomized Control Trial [NCT04717193] | Phase 2 | 100 participants (Anticipated) | Interventional | 2021-05-28 | Recruiting |
Ultrasound-Guided Erector Spinae Plane Block Versus Intercostal Nerve Block For Postoperative Pain Control in Video-Assisted Thoracoscopic Surgery: A Prospective, Double Blind Randomized Controlled Trial [NCT03902782] | | 100 participants (Anticipated) | Interventional | 2019-06-26 | Recruiting |
The Bupivacaine Dose Sparing Effect of Intrathecal Epinephrine for Spinal Anesthesia in Total Knee Replacement Arthroplasty [NCT01261078] | | 75 participants (Anticipated) | Interventional | 2010-12-31 | Completed |
A Randomised Clinical Trial Comparing Endovenous Laser Ablation and Mechanochemical Ablation (ClariVein®) in the Management of Superficial Venous Insufficiency [NCT02627846] | Phase 4 | 150 participants (Actual) | Interventional | 2015-06-01 | Completed |
Randomized Double-blind Clinical Trial Comparing the Cardiovascular Effects of Local Anesthesia Solutions Containing 1:100,000 and 1:200,000 of Epinephrine Concentrations [NCT02735018] | Phase 4 | 40 participants (Actual) | Interventional | 2014-12-31 | Completed |
The Effect of BMI on Median Effective Dose (ED50) of Intrathecal Hyperbaric Bupivacaine for Total Knee Replacement Arthroplasty [NCT01291186] | | 108 participants (Actual) | Interventional | 2010-01-31 | Completed |
"The Effect Of Subcutaneous Epinephrine Dosage On Blood Loss In Surgical Incision" [NCT05670808] | Phase 1 | 90 participants (Anticipated) | Interventional | 2023-02-01 | Not yet recruiting |
Comparison of the Analgesic Effect of Femoral Nerve Block, Intraarticular Infiltration or a Combination of Both in the Control of Pain in Total Knee Arthroplasty [NCT01304212] | Phase 4 | 137 participants (Actual) | Interventional | 2011-04-30 | Completed |
Study of Drug Exposure in Systemic Circulation of Primatene Mist (0.25mg) by Oral Inhalation, Versus Epinephrine Injection (0.30mg) by Intramuscular Injection and ProAir (0.18mg) by Oral Inhalation in Healthy Individuals: A Randomized, Safety Evaluator-bl [NCT04207840] | Phase 4 | 28 participants (Actual) | Interventional | 2019-12-09 | Completed |
Surgicel; a Probable Analgesic Reservoir for Post-laparoscopic Cholecystectomy Pain Management; Randomized Controlled Double-blind Trial [NCT03730714] | Phase 2/Phase 3 | 90 participants (Actual) | Interventional | 2018-11-15 | Completed |
Tumescent Antibiotic Delivery for Prevention of Surgical Site Infection: A Multicenter Open Label Randomized Clinical Trial [NCT02503904] | Phase 2/Phase 3 | 400 participants (Anticipated) | Interventional | 2015-10-31 | Not yet recruiting |
2%-Mepivacaine With Two Different Vasoconstrictors; 1:20.000 Levonordefrin or 1:100.000 Epinephrin for Local Anesthesia in Third Molar Surgery: A Comparative Randomized Clinical Trial [NCT02603198] | | 30 participants (Anticipated) | Interventional | 2014-08-31 | Active, not recruiting |
An Analysis of the Functional Benefit, Narcotic Use and Time to Discharge Readiness Following the Implementation of a Comprehensive Pain Management Protocol for Primary Total Knee Arthroplasty [NCT02474654] | Phase 4 | 220 participants (Actual) | Interventional | 2015-07-31 | Completed |
Multimodal Nonopioid Pain Protocol Following Shoulder Arthroplasty Surgery [NCT05488847] | Phase 4 | 80 participants (Anticipated) | Interventional | 2022-06-25 | Recruiting |
Role of Chemokine and Chemokine Receptor in Psoriasis [NCT03302390] | | 0 participants (Actual) | Observational | 2017-04-17 | Withdrawn(stopped due to PI failed to submit study for continuing review by IRB) |
A Pilot Clinical Trial to Reduce Side-effects of Autologous Skin Tissue Harvesting [NCT02234193] | Early Phase 1 | 8 participants (Actual) | Interventional | 2016-06-30 | Completed |
Comparing the Effect of 4% Articaine and 2% Mepivacaine Without Palatal Injection in Pain Assessment During Maxillary Teeth Extraction- A Randomized Clinical Trial [NCT03470532] | Phase 4 | 60 participants (Actual) | Interventional | 2017-02-25 | Completed |
Phase III Study of Epinephrine Inhalation Aerosol for Evaluation of Efficacy and Safety of E004 in Children With Asthma [NCT01460511] | Phase 3 | 70 participants (Actual) | Interventional | 2011-10-31 | Completed |
The Effect of Epinephrine, Norepinephrine and Phenylephrine on Intraoperative Hemodynamic Performance - a Prospective Double-blinded Randomized Clinical Trial [NCT05492968] | Phase 4 | 225 participants (Anticipated) | Interventional | 2022-09-01 | Recruiting |
The Effect of The Serratus Block on Analgesia After Breast Surgery A Randomized Controlled Double-Blinded Study [NCT02453516] | Phase 2/Phase 3 | 40 participants (Actual) | Interventional | 2014-10-29 | Completed |
Comparison of Zero- and Two-centimeter Distance From Sapheno-femoral Junction in Laser Ablation of Long Saphenous Vein Incompetence: Evaluating the Kissing Technique [NCT05707169] | | 800 participants (Anticipated) | Interventional | 2023-01-04 | Active, not recruiting |
The Effect of Intracameral Carbachol and Epinephrine Use on Choroidal Thickness After Uncomplicated Phacoemulsification [NCT05225597] | | 81 participants (Actual) | Interventional | 2021-01-01 | Completed |
Managing Post Spinal Hypotension During Elective Cesarean Section: Epinephrine Versus Ephedrine, a Randomized Double-blinded Controlled Trial [NCT03704909] | Phase 4 | 143 participants (Actual) | Interventional | 2018-09-01 | Completed |
The Randomized Controlled Trial of Inferior Vena Cava Ultrasound-guided Fluid Management in Septic Shock Resuscitation [NCT03020407] | | 211 participants (Actual) | Interventional | 2017-01-18 | Completed |
Management of Acute Pulmonary Hypertensive Crisis in Children With Known Pulmonary Arterial Hypertension [NCT05439460] | Phase 4 | 15 participants (Actual) | Interventional | 2012-01-31 | Completed |
A Phase 2B, Randomized, Controlled Study of HTX-011 Administered Via Pectoral Nerve Block in Subjects Undergoing Upper Extremity Surgery for Augmentation Mammoplasty [NCT03011333] | Phase 2 | 243 participants (Actual) | Interventional | 2017-01-14 | Completed |
Effect of Local Infiltration Anesthesia With Ropivacaine on Pain After Primary Total Hip Arthroplasty [NCT02359136] | | 116 participants (Actual) | Interventional | 2013-03-31 | Completed |
Adrenal Artery Ablation for Primary Aldosteronism:A Randomized, Parallel, Active-controlled Clinical Trial to Evaluate the Efficacy and Safety of Adrenal Artery Ablation(AAA)in the Treatment of Primary Aldosteronism [NCT03653845] | Phase 3 | 40 participants (Anticipated) | Interventional | 2018-07-01 | Recruiting |
"Clinical Study to Evaluate Efficacy and Safety of CEGP003(Wound Dressing Solution Containing EGF) for Achieving Hemostasis and Protecting Ulcer in Patients With Acute Peptic Ulcer Bleeding: A Prospective, Randomized Trial" [NCT03469167] | | 76 participants (Actual) | Interventional | 2014-10-15 | Completed |
Comparison of the Effects of Two Concentrations of Adrenaline (0.33 mg/l vs 1 mg/l) in the Irrigation Serum of Arthroscopic Shoulder Surgery. [NCT05439213] | | 170 participants (Anticipated) | Interventional | 2022-06-22 | Recruiting |
Ultrasound-Guided Versus Conventional Method for Caudal Block in Children [NCT03427437] | | 275 participants (Actual) | Interventional | 2017-02-01 | Completed |
Comparison of the Effect of a Single Shot Saphenous Block With Plain Bupivacaine vs. Protracted Bupivacaine Mixture as a Supplement to Continuous Sciatic Catheter After Major Ankle and Foot Surgery [NCT02346110] | Phase 4 | 40 participants (Actual) | Interventional | 2015-04-30 | Completed |
Nebulized Hypertonic Saline (3%) Versus Nebulized Adrenaline for Treatment of Bronchiolitis: A Randomized Control Trial [NCT03614273] | | 60 participants (Actual) | Interventional | 2015-03-01 | Completed |
A Prospective, Randomized Comparison Between Single and Double Injection Ultrasound-Guided Axillary Brachial Plexus Block [NCT02334176] | | 320 participants (Anticipated) | Interventional | 2015-01-31 | Not yet recruiting |
An Exploratory Phase I Randomized, Single-site, Double-blind, Active-controlled, Parallel-group, Single-administration, Dose-escalation Trial to Investigate the Safety and Tolerability of Neosaxitoxin Alone and in Combination With Bupivacaine (With and Wi [NCT03399435] | Phase 1 | 242 participants (Actual) | Interventional | 2018-01-30 | Terminated(stopped due to The sponsor decided to stop further dosing of healthy volunteers after reviewing the obtained efficacy data. The decision is not related to any safety concern.) |
Pectoral Nerves Block to Relieve Post-sternotomy Pain After Cardiac Surgery [NCT04282239] | | 0 participants (Actual) | Interventional | 2021-03-01 | Withdrawn(stopped due to Did not have the staff to conduct the study) |
Pulpal Blood Flow With the Use of Intra-nasal Anesthetic: a Randomized Double-blind Crossover Study [NCT03368391] | Phase 4 | 25 participants (Anticipated) | Interventional | 2018-01-03 | Not yet recruiting |
WALANT Versus Axillary Brachial Plexus Block in Carpal Tunnel Release: a Non-inferiority Randomized Controlled Trial [NCT06040840] | | 130 participants (Anticipated) | Interventional | 2023-11-01 | Not yet recruiting |
The Effect of Protracted Saphenous Nerve and Obturator Nerve Block Versus Saphenous Nerve Block Versus Local Infiltration Analgesia on Opioid Consumption, Pain, Block Duration of Action and Mobilization After Total Knee Arthroplasty. [NCT02067078] | Phase 4 | 75 participants (Actual) | Interventional | 2014-02-28 | Completed |
Efficacy of Lidocaine Saline Irrigation in Patients Undergoing Shoulder Arthroscopy: Randomized Controlled Study [NCT05624957] | | 50 participants (Actual) | Interventional | 2022-11-25 | Completed |
A Volunteer Study to Determine the Anatomical Distribution of Injectate, the Extent of Sensory Block, and the Pharmacokinetics of Ropivacaine Following Erector Spinae Plane (ESP) Blocks. [NCT03476642] | Phase 4 | 24 participants (Anticipated) | Interventional | 2019-07-02 | Recruiting |
A Randomized, Double-blinded or Evaluator-blinded, Placebo and Active Controlled, Six-arm, Crossover, Single Dose, Dose-ranging Study, for Initial Evaluation of Safety and Efficacy in Asthma Patients [NCT01025648] | Phase 1/Phase 2 | 9 participants (Actual) | Interventional | 2009-12-31 | Terminated(stopped due to Optimization of protocol) |
Evaluation of Cardiac Arrhythmias in Patients Undergoing Kidney Cancer Surgery Depending on the Anaesthesia Method [NCT02988219] | Phase 4 | 50 participants (Actual) | Interventional | 2010-06-30 | Completed |
Prospective Randomized Clinical Trial to Evaluate the Use of Caudal Nerve Blocks in Adult Penile Prosthesis Surgery [NCT02740127] | Phase 3 | 52 participants (Actual) | Interventional | 2016-06-30 | Completed |
Influence of Synacthen Infusion on the Results of Adrenal Venous Sampling in Patient With Primary Aldosteronism [NCT02127840] | Phase 4 | 40 participants (Anticipated) | Interventional | 2011-03-31 | Recruiting |
Phase II Clinical Trial for a Stepwise Progression in the Treatment of Cardiogenic Shock [NCT02591771] | Phase 2 | 24 participants (Actual) | Interventional | 2015-10-31 | Completed |
Magnesium-sulfate as Adjuvant in Prehospital Femoral Nerve Block for Patient With Diaphysial Femoral Fracture: a Randomized Controlled Trial [NCT03597945] | | 48 participants (Actual) | Interventional | 2015-04-30 | Completed |
Bacteriostatic Saline as a Local Anesthetic in Minor Eyelid Procedures [NCT05294640] | Phase 4 | 95 participants (Actual) | Interventional | 2022-05-17 | Completed |
Pharmacokinetic Study of Epinephrine During Cardiac Arrest Determining T1/2 and Time to Peak Concentration [NCT03036202] | | 8 participants (Actual) | Observational | 2017-06-26 | Completed |
Is the Direct Inferior Alveolar Nerve Block Required for Third Lower Molar Extraction? [NCT03443726] | | 120 participants (Actual) | Interventional | 2017-06-10 | Completed |
Three-level Injection Paravertebral Block Using Paravertebral Catheter Compared to General Anesthesia in Mastectomy Surgery [NCT02065947] | Phase 1/Phase 2 | 60 participants (Actual) | Interventional | 2013-10-31 | Completed |
Anterior Ethmoidal Nerve Block in Prevention of Postoperative Agitation Following Nasal Surgeries With Nasal Packs Under General Anesthesia: A Double Blind Randomized Control Trial [NCT03427502] | | 100 participants (Actual) | Interventional | 2018-06-01 | Completed |
Randomized Clinical Trial Examining Use of Adjunct EXPAREL for Post-tonsillectomy Pain Management in Adults [NCT03420638] | Phase 4 | 38 participants (Anticipated) | Interventional | 2018-02-15 | Recruiting |
Effect of Local Infiltration Anesthesia in a Hip Arthroplasty Fast Track Program. [NCT03513276] | Phase 4 | 63 participants (Actual) | Interventional | 2016-02-29 | Completed |
Bacteraemia Secondary to Tooth Extraction: a Randomized Clinical Trial on Efficacy of Three Different Chlorhexidine Prophylaxis Protocols [NCT02150031] | Phase 4 | 208 participants (Actual) | Interventional | 2010-12-31 | Completed |
Epinephrine Inhalation Aerosol USP, an HFA-MDI: Clinical Study-C For Evaluation Of Efficacy And Safety In Asthma Patients [NCT01357642] | Phase 3 | 373 participants (Actual) | Interventional | 2011-07-31 | Completed |
A 3-month Safety Evaluation Extension to the 12-week E004-C Study in Asthma Patients (A Double Blinded, Placebo-controlled, Parallel, 3-month Safety Study in Adolescent and Adult Patients With Asthma) [NCT01476904] | Phase 3 | 208 participants (Actual) | Interventional | 2011-11-30 | Completed |
Usage of Tranexamic Acid During Colonic Endoscopic Resection Procedures for Reduction Intraprocedural and Postprocedural Bleeding [NCT05345613] | Phase 4 | 200 participants (Anticipated) | Interventional | 2022-05-01 | Recruiting |
Effect of Lidocaine/Dexamethasone on the Success of IANB in Patients With Irreversible Pulpitis [NCT03531970] | Phase 2/Phase 3 | 100 participants (Actual) | Interventional | 2016-08-01 | Completed |
Photobiomodulation for Controlling Pre-Local Anesthetic Injection Pain: A Double-Blind, Randomized Controlled Clinical Study [NCT06128590] | | 50 participants (Anticipated) | Interventional | 2023-11-15 | Not yet recruiting |
Protracted Mixture of Local Anesthetics for Major Foot and Ankle Surgery. A Randomized Double-blind, Controlled Study Comparing Bupivacaine-Epinephrine 0.5% Versus Bupivacaine-Epinephrine 0.5% With Dexamethasone [NCT02526199] | Phase 4 | 56 participants (Actual) | Interventional | 2015-08-31 | Completed |
An Open, Randomised, Parallel Group Controlled, Single Centre Safety Study to Assess the Safety and Efficacy of Tri-Solfen in Providing Anaesthesia Prior to Surgical Debridement of Leg Ulcers and Post-operative Pain Relief [NCT03865147] | Phase 2 | 90 participants (Anticipated) | Interventional | 2019-01-15 | Recruiting |
Does the Use of CBCT Pre-operative Measurements Improve the Success Rate of Inferior Alveolar Nerve Block? - A Randomized Controlled Clinical Trial [NCT05406895] | | 200 participants (Anticipated) | Interventional | 2022-05-25 | Recruiting |
Quadratus Lumborum Block Versus Control for Total Hip Arthroplasty [NCT03408483] | Phase 2/Phase 3 | 80 participants (Actual) | Interventional | 2018-04-01 | Completed |
Randomized, Double Blind Trial of Thoracolumbar Interfascial Plane Block and Erector Spinae Plane Block for Adult Spinal Surgery [NCT03931343] | | 60 participants (Anticipated) | Interventional | 2020-12-31 | Not yet recruiting |
Local Infiltration Analgesia During Total Knee Arthroplasty - Reduced Opiate Consumption and Faster Mobilisation Postoperatively - Randomized Controlled Trial [NCT01305733] | | 60 participants (Actual) | Interventional | 2011-03-31 | Active, not recruiting |
Low Dose EPInephrine to Improve Platelet Reactivity in TICagrelor-treated Subjects: A Proof of Concept Study in Healthy Volunteers (EPITIC) [NCT03441412] | Phase 1 | 10 participants (Actual) | Interventional | 2018-02-28 | Completed |
Adrenal Venous Sampling Via an Antecubital Approach: A Multicenter Study [NCT03778645] | | 1,500 participants (Anticipated) | Observational | 2018-07-01 | Recruiting |
Evaluation of Efficacy and Safety for Single Dose of E004 in Children With Asthma (A Randomized, Double-Blind, Placebo-Controlled, Crossover, Single Dose Study in 4 - 11 Year Old Children With Asthma) [NCT01737905] | Phase 3 | 28 participants (Actual) | Interventional | 2012-10-31 | Completed |
A Prospective, Randomized, Single-Blind, Active Control Trial to Compare Safety and Effectiveness Of Liposomal Bupivacaine (Exparel) to Standard Bupivacaine HCl (Marcaine) for Pain Management in Patients Undergoing Video-Assisted Thoracoscopic Lobectomy [NCT03682224] | Phase 3 | 57 participants (Actual) | Interventional | 2018-07-05 | Completed |
How Successful is Supplemental Intraseptal Anaesthesia in Patients With Mandibular Teeth Extraction or Irreversible Pulpitis [NCT03880409] | Phase 1 | 100 participants (Actual) | Interventional | 2019-02-09 | Completed |
Role of Platelet Rich Plasma in the Treatment of Actively Bleeding Peptic Ulcer [NCT03733171] | | 80 participants (Anticipated) | Interventional | 2018-09-20 | Recruiting |
Effect of Buffered Lidocaine With Epinephrine in Local Anesthesia During Subcutaneous Implantable Venous Access Devices Insertion: Double Blind Randomized Study. [NCT03628430] | | 120 participants (Actual) | Interventional | 2017-01-01 | Completed |
ENHANCED RECOVERY AFTER ORTHOGNATHIC SURGERY USING LIPOSOMAL BUPIVACAINE: A RANDOMIZED CONTROL TRIAL [NCT03844451] | Phase 4 | 75 participants (Anticipated) | Interventional | 2019-05-17 | Recruiting |
WALANT Technique (Wide Awake Local Anesthesia No Tourniquet) in Association With Analgesic Troncular Blocks at the Wirst for Carpal Tunnel Release. [NCT04494100] | | 60 participants (Actual) | Interventional | 2020-09-11 | Completed |
Formulations of Liposomal Local Anesthetics for Dental Anesthesia [NCT01307969] | Phase 1 | 40 participants (Actual) | Interventional | 2007-02-28 | Completed |
Comparison of Postoperative Pain With Two Different Types of Local Anesthesia in Surgery for a Drooping Eyelid [NCT01350024] | | 34 participants (Actual) | Interventional | 2011-05-01 | Completed |
[NCT02864095] | | 200 participants (Anticipated) | Interventional | 2015-05-31 | Recruiting |
A Prospective, Randomized, Controlled Trial of Combination Vasopressin and Epinephrine to Epinephrine Only for In-Intensive Care Unit Pediatric Cardiopulmonary Resuscitation [NCT00628550] | Phase 1 | 130 participants (Anticipated) | Interventional | 2008-04-30 | Completed |
A Randomized, Prospective Trial Comparing Peri-articular Injection Utilizing a Pain Cocktail With and Without Exparel [NCT02571283] | Phase 4 | 0 participants (Actual) | Interventional | 2015-10-31 | Withdrawn(stopped due to PI decided to focus on more current topics of interest.) |
Evaluation of Liposomal Bupivacaine Compared to Usual Care and Its Effects on Pain for Cardiac Surgery [NCT04065919] | Phase 4 | 300 participants (Anticipated) | Interventional | 2019-10-01 | Enrolling by invitation |
Hypoglycemia Associated Autonomic Failure in Type 1 DM, Question 5 [NCT00605774] | | 0 participants (Actual) | Interventional | | Withdrawn |
Hypoglycemia Associated Autonomic Failure in Type 1 DM, Question 4 [NCT00608816] | | 0 participants (Actual) | Interventional | | Withdrawn |
Analgesic Benefit of Locally Injected Bupivacaine on Perineal Pain Among Women With Epidural Anesthesia After a Vaginal Delivery: a Randomized, Single-masked, Controlled Trial [NCT03672500] | | 23 participants (Actual) | Interventional | 2018-09-14 | Terminated(stopped due to Recruitment issues) |
Intraoperative Use of Perineal Block for Hemorrhoidectomy [NCT04288349] | | 100 participants (Anticipated) | Interventional | 2020-02-20 | Recruiting |
Efficacy and Safety of Periarticular Multimodal Drug Injections in Total Knee Arthroplasty [NCT00901628] | Phase 4 | 101 participants (Actual) | Interventional | 2008-04-30 | Completed |
[NCT02839356] | Phase 4 | 670 participants (Anticipated) | Interventional | 2016-07-31 | Recruiting |
Multimodal Drug Infiltration in Total Knee Arthroplasty: Is Posterior Capsular Infiltration Worth the Risk? A Prospective, Double-Blind, Randomized Controlled Trial [NCT02860949] | Phase 2 | 90 participants (Actual) | Interventional | 2014-04-30 | Completed |
[NCT02807298] | Phase 3 | 25 participants (Actual) | Interventional | 2014-06-30 | Completed |
A Randomized, Single-Blinded, Placebo-Controlled Study Evaluating Postoperative Non-Opioid Pain Management Utilizing Local Anesthetics Coupled With Modulated Coagulation [NCT04814433] | Phase 4 | 5 participants (Actual) | Interventional | 2021-03-24 | Terminated(stopped due to Both lack of enrollment as well as study staff turnover) |
Effect of Sodium Bicarbonate Buffered Lidocaine on the Success of Inferior Alveolar Nerve Block for Teeth With Symptomatic Irreversible Pulpitis: A Prospective, Randomized Double-blind Study [NCT02226913] | Phase 3 | 80 participants (Actual) | Interventional | 2013-02-28 | Completed |
Occurrence of Heart Arrhythmia During Restorative Dental Procedure Under Local Anesthesia , in Heart Failure Pacients. A Double-blind Study [NCT02228083] | | 70 participants (Anticipated) | Interventional | 2014-09-30 | Recruiting |
Effectiveness of Bupivacaine With Epinephrine Injections Into the Uterosacral Ligaments for Post-operative Pain Control and the Use of Narcotic Pain Medication Following Robotic Assisted Total Hysterectomies [NCT02230735] | | 0 participants (Actual) | Interventional | 2014-08-31 | Withdrawn(stopped due to Study was never started.) |
Prophylactic Topical Epinephrine to Reduce Transbronchial Lung Biopsy-related Hemorrhage in Lung Transplant Recipients: a Prospective Double-blind Placebo-controlled Trial (PROPHylactic Epinephrine in Transbronchial Biopsy [PROPHET] Trial) [NCT03126968] | Phase 2/Phase 3 | 100 participants (Actual) | Interventional | 2017-07-01 | Completed |
A Comparison Between Tourniquet Application and Epinephrine Injection for Hemostasis During Hypospadias Surgery: the Effect on Bleeding and Post-operative Outcome [NCT02268019] | | 70 participants (Anticipated) | Interventional | 2013-01-31 | Recruiting |
Shamrock Versus Lumbar Ultrasound Trident - Ultrasound Guided Block of the Lumbar Plexus: A Randomized Controlled Trial [NCT02255591] | Phase 4 | 20 participants (Actual) | Interventional | 2015-02-28 | Completed |
Analgesic Benefit of PECS Blocks for Biceps Tenodesis Shoulder Surgery [NCT02741713] | Phase 3 | 40 participants (Actual) | Interventional | 2016-04-30 | Completed |
Double-Blinded Randomized Controlled Study Investigating the Efficacy of Exparel (Liposomal Bupivacaine) for Postoperative Pain Relief in Mandibular Third Molar Extractions [NCT05374499] | Phase 4 | 40 participants (Anticipated) | Interventional | 2022-09-01 | Active, not recruiting |
Fractional Carbon Dioxide Laser Assisted Delivery of Topical Anesthetics: a Randomized Controlled Pilot Study [NCT02246179] | Phase 4 | 10 participants (Actual) | Interventional | 2014-09-30 | Completed |
A Randomized Comparison Between 1 Plane - 1 Injection (Cluster Approach) and 2 Plane - 2 Injection Ultrasound-guided Supraclavicular Brachial Plexus Block (US-SCBPB) in Upper Extremity Surgery [NCT02505633] | | 36 participants (Actual) | Interventional | 2015-07-31 | Completed |
High Volume, Multilevel Local Anesthetic-Epinephrine Infiltration in Kyphoscoliosis Surgery: Blood Conservation and Analgesia [NCT03319563] | | 52 participants (Actual) | Interventional | 2017-04-11 | Completed |
The Effect of Adding Nebulized Epinephrine in Asthma Exacerbation Management in Pediatric Age Group Compared to Standard of Care: Superiority Trial [NCT05667727] | Phase 4 | 30 participants (Anticipated) | Interventional | 2023-10-15 | Recruiting |
Periarticular Bupivacaine + Meloxicam ER Solution Versus Standard Practice During Total Knee Arthroplasty: A Single Institution, Single-blinded, Randomized Clinical Trial [NCT05188053] | Phase 4 | 98 participants (Anticipated) | Interventional | 2022-02-07 | Enrolling by invitation |
A Two-Treatment, Sequential, Crossover Study of the Pharmacokinetics of Adrenaline After Administration of ARS -1 in Subjects With Upper Respiratory Tract Infection (Infectious Rhinitis) [NCT04930900] | Phase 1 | 15 participants (Actual) | Interventional | 2021-08-09 | Completed |
Efficacy of Peri-Incisional Multimodal Drug Injection Following Operative Management of Femur Fractures: A Randomized Controlled Trial [NCT02793947] | Phase 4 | 102 participants (Actual) | Interventional | 2015-05-31 | Completed |
A Randomized Controlled Trial of Bupivacaine for Local Pain Control Following Perineal Laceration Repair in Patients With Pre-existing Epidural Analgesia [NCT05972681] | | 60 participants (Anticipated) | Interventional | 2023-12-31 | Not yet recruiting |
Efficacy of Multimodal Periarticular Injections in Operatively Treated Ankle Fractures: A Randomized Controlled Trial [NCT02967172] | Phase 4 | 100 participants (Actual) | Interventional | 2016-10-31 | Completed |
[NCT02135627] | | 20 participants (Actual) | Interventional | 2014-04-30 | Completed |
Efficacy of Adrenaline in Periarticular Analgesic Injection on Postoperative Pain Control After Total Knee Arthroplasty: A Randomized Controlled Trial [NCT03549221] | Phase 2 | 82 participants (Anticipated) | Interventional | 2018-01-26 | Recruiting |
Epinephrine Self-injection and Self-management of Food Allergies [NCT02417493] | | 60 participants (Actual) | Interventional | 2015-03-31 | Completed |
Bilateral Paravertebral Blockade for Improvement of Quality of Recovery Following Cardiac Surgery (P-QOR): a Randomized Controlled Trial [NCT06008821] | | 224 participants (Anticipated) | Interventional | 2023-09-30 | Not yet recruiting |
Postoperative Pain Management Following Total Hip Arthroplasty. A Comparison Between Local Infiltration Analgesia and Ultrasound Guided 3-in-1 Block [NCT02568995] | Phase 3 | 55 participants (Actual) | Interventional | 2014-05-31 | Completed |
Assessment of Airway Obstruction in Infants With Lower Respiratory Infections [NCT00435994] | | 59 participants (Actual) | Interventional | 2003-12-31 | Completed |
Tumescent Lidocaine Bioavailability and Absorption Kinetics:Maximum Safe mg/kg Lidocaine Dosage [NCT00977028] | Phase 1/Phase 2 | 14 participants (Actual) | Interventional | 2005-01-31 | Enrolling by invitation |
Awake Caudal Catheter Infusion Versus General Anesthesia and Single-dose Caudal Injection for Preterm NICU Patients Undergoing Inguinal Herniorraphy. [NCT05919732] | Phase 4 | 40 participants (Actual) | Interventional | 2016-03-08 | Completed |
Can Epinephrine Coated Syringe for Subcutaneous Immunotherapy (SCIT) Reduce Large Local Reaction? [NCT03963115] | Phase 1/Phase 2 | 17 participants (Actual) | Interventional | 2018-10-24 | Completed |
A Phase 2 Multicenter, Randomized, Double-blind, Parallel-group, Active-control, Dose-ranging Study to Evaluate the Safety, Efficacy, and Comparative Systemic Bioavailability of a Single Administration of SKY0402 Via Local Infiltration for Prolonged Posto [NCT00485693] | Phase 2 | 138 participants (Actual) | Interventional | 2007-06-30 | Completed |
A Single Center, Prospective, Observational Study to Explore and Evaluate the Differences of Cognitive Function and Brain Function Between Non-functioning Adrenal Adenomas and Autonomous Cortisol Secretion Patients, and the Different Treatments Methods on [NCT05357456] | | 62 participants (Anticipated) | Observational | 2021-10-01 | Recruiting |
Local Infiltration Analgesia With Ropivacaine, Ketorolac and Epinephrine Intra- and Postoperatively in Total Knee Arthroplasty [NCT00799175] | | 48 participants (Actual) | Interventional | 2007-04-30 | Completed |
Local Infiltration Analgesia or Intrathecal Morphine in Total Knee Arthroplasty [NCT00992082] | | 50 participants (Anticipated) | Interventional | 2009-08-31 | Recruiting |
Effectiveness of Caudal Epidural Block on Intraoperative Blood Loss During Hypospadias Repair; A Randomized Clinical Trial [NCT02752308] | Phase 2/Phase 3 | 60 participants (Actual) | Interventional | 2014-09-30 | Completed |
Platform Adaptive Embedded Trial for Acute Respiratory Distress Syndrome [NCT05658692] | Phase 4 | 1,000 participants (Anticipated) | Interventional | 2022-10-01 | Recruiting |
Comparison of Perioperative Opioid Consumption Following Pectoral Nerve Block Under General Anesthesia for Breast Cancer Surgery: A Randomized Clinical Trial [NCT02741232] | | 50 participants (Actual) | Interventional | 2016-03-31 | Completed |
The Use of Tranexamic Acid in Irrigation Fluid to Improve Arthroscopic Visualization in Shoulder Surgery: A Randomized Controlled Trial [NCT04594408] | Phase 4 | 128 participants (Actual) | Interventional | 2020-09-01 | Active, not recruiting |
The Prevention of Hypotension After Epidural Analgesia After Major Surgery by Adding Epinephrine to Infusions to Counteract Sympathectomy: a Double- Blind, Controlled, Randomized, Prospective Dose-finding Study [NCT02722746] | | 66 participants (Actual) | Interventional | 2016-11-15 | Completed |
Efficacy of Multimodal Peri- and Intraarticular Drug Injections in Total Knee Arthroplasty [NCT00562627] | Phase 4 | 102 participants (Actual) | Interventional | 2007-11-30 | Completed |
Interest of the Alkalinization of the Adrenaline Lidocaine Solution for Conversion of Epidural Analgesia Into Epidural Anesthesia During an Emergency Caesarean [NCT04255121] | Phase 3 | 400 participants (Actual) | Interventional | 2020-06-22 | Completed |
Randomized Controlled Trial of Dopamine, Adrenaline, and Blood Transfusion for Treatment of Fluid Refractory Shock in Children With Severe Acute Malnutrition or Severe Underweight and Cholera or Other Dehydrating Diarrheas [NCT04750070] | Phase 3 | 135 participants (Anticipated) | Interventional | 2021-08-17 | Recruiting |
Effect of Intrapartum Epidural Fentanyl Upon Breastfeeding in the Immediate Postpartum Period: a Randomized, Controlled, Double-blinded Study [NCT01497509] | | 0 participants (Actual) | Interventional | 2012-05-31 | Withdrawn(stopped due to Study never started) |
Efficacy of Post-FESS Implantation of Composite Removable Sinus Stent System to Prevent Post-Operative Complications and Revision Surgery [NCT02812199] | | 30 participants (Anticipated) | Interventional | 2016-08-31 | Recruiting |
A Multi-center, Randomized, Double-blind, Crossover, phase4 Trial to Evaluate the Efficacy on Local Anesthesia and Safety of 2% Lidocaine HCl With Different Epinephrine Concentration in Patients Undergoing Surgical Extraction of Impacted Lower Third Molar [NCT02696369] | Phase 4 | 65 participants (Actual) | Interventional | 2014-12-31 | Completed |
The Influence of Local Infiltration Analgesia by Catheter in Postoperative Control Pain After Total Hip Replacement [NCT02630160] | Phase 4 | 100 participants (Actual) | Interventional | 2013-03-31 | Completed |
A Novel Method for Chronic Anal Fissure Treatment: Adipose Derived Regenerative Cells - A Pilot Study [NCT02628522] | | 6 participants (Actual) | Interventional | 2014-12-31 | Completed |
A Phase 1, 2-Part Study in Healthy Male and Female Participants; Part 1 - A Randomised, Double-Blind, Placebo-Controlled, Single Ascending Dose-Escalation Study of Inhaled DMC-IH1; Part 2 - An Open-Label, 3-Arm Study Assessing the Carryover Effects of Inh [NCT06013150] | Phase 1 | 63 participants (Anticipated) | Interventional | 2023-10-23 | Not yet recruiting |
Does the Addition of Epinephrine to Bilateral Ultrasound Guided Pterygopalatine Ganglion Block Reduce Bleeding During Functional Endoscopic Sinus Surgery (FESS)? A Pilot Study [NCT03970655] | Phase 1/Phase 2 | 80 participants (Anticipated) | Interventional | 2019-09-25 | Recruiting |
The Efficacy of Liposomal Bupivacaine in the Management of Post-operative Pain Following Septorhinoplasty: A Double-blinded, Prospective Clinical Trial [NCT05964868] | Phase 3 | 72 participants (Anticipated) | Interventional | 2024-01-31 | Not yet recruiting |
Postmortem Evaluation of Adrenal and Other Endocrine Tumors in Patients With Sudden Death Without Definitive Causative Diagnosis (PEA-SuddenDeath) [NCT05446779] | | 400 participants (Anticipated) | Observational | 2022-06-03 | Recruiting |
The Effects of Hydrocortisone in Endotoxemia in Normal Volunteers [NCT01064986] | Phase 1 | 12 participants (Actual) | Interventional | 2010-02-28 | Completed |
Analgesic Efficacy of Intravenous Lidocaine for Postoperative Pain Following Adult Spine Surgery: A Randomized Controlled Trial [NCT01043211] | | 0 participants (Actual) | Interventional | 2012-01-31 | Withdrawn(stopped due to Did not have the research staff necessary to follow through with this study.) |
Diesel Exhaust Inhalation, Systemic Nitric Oxide Inhibition and Cardiac Output [NCT01060930] | | 14 participants (Actual) | Interventional | 2010-03-31 | Completed |
Endoscopic Application of a Hemostatic Powder TC-325 Versus Standard Treatment in the Control of Acute Upper Gastrointestinal Bleeding From Nonvariceal Causes; A Non-inferiority Randomized Trial [NCT02534571] | Phase 3 | 224 participants (Actual) | Interventional | 2015-09-07 | Completed |
A Randomized Comparison Between 1 Plane-2 Injection and 2 Plane-2 Injection Ultrasound-guided Supraclavicular Brachial Plexus Block (US-SCBPB) in Upper Extremity Surgery [NCT02533557] | | 70 participants (Actual) | Interventional | 2015-08-31 | Completed |
Double Blinded Controled Study:Treatment With Adrenaline Inhalation Versus Nasal Decongestant Drops for Bronchiolitis [NCT00622817] | | 65 participants (Actual) | Interventional | 2004-10-31 | Completed |
Comparison of the Analgesic Duration of 0.5% Bupivacaine With 1:200,000 Epinephrine Versus 0.5% Ropivicaine Versus 1 % Ropivicaine for Low Volume Ultrasound-guided Interscalene Brachial Plexus Block [NCT02643563] | | 60 participants (Actual) | Interventional | 2016-01-31 | Completed |
A Phase 1 Comparative Bioavailability Study of Inhaled Epinephrine and Intramuscular Epinephrine Administered to Healthy Adults [NCT05152901] | Phase 1 | 23 participants (Actual) | Interventional | 2022-01-06 | Completed |
Intraoperative Injection of Exparel Effect on Postoperative Opioid Use in Thyroid and Parathyroid Surgery [NCT04085913] | Early Phase 1 | 100 participants (Anticipated) | Interventional | 2019-09-30 | Enrolling by invitation |
Comparing General Anesthesia With Single Injection Peribulbar Block With Articaine 4% vs Lidocaine 2% vs Mepivacaine 3 % for Prevention of Oculocardiac Reflex in Children Undergoing Strabismus Surgery : A Randomized Control Study [NCT05728151] | | 55 participants (Anticipated) | Interventional | 2023-02-12 | Recruiting |
Effects of Pre-emptive Scalp Infiltration With Ketorolac and Ropivacaine for Postoperative Pain Relief After Elective Supratentorial Craniotomy (PAINLESS) [NCT04141319] | Phase 4 | 100 participants (Anticipated) | Interventional | 2021-12-31 | Not yet recruiting |
''To Compare the Response Rate of Noradrenaline vs. Terlipressin in Hepatorenal Syndrome in Patients With Acute on Chronic Liver Failure' [NCT02573727] | | 120 participants (Actual) | Interventional | 2015-10-31 | Completed |
Dynamics and State Transitions During Resuscitation in In-hospital Cardiac Arrest [NCT00920244] | | 285 participants (Actual) | Observational | 2009-08-31 | Completed |
A Prospective, Randomized, Double-Blind Controlled Clinical Trial to Evaluate the Post-Operative Blood Loss and Transfusion Rate Following Total Joint Arthroplasty With Intra-articular Injection of Bupivacaine and Epinephrine [NCT00737139] | | 33 participants (Actual) | Interventional | 2008-09-30 | Terminated(stopped due to Prohibitively expensive and efficacy of tranexamic acid rendered topic clinically less relevant.) |
[NCT02593370] | Phase 1 | 26 participants (Actual) | Interventional | 2015-10-31 | Completed |
Articaine Efficacy and Safety in Young Children Below Age of Four Years: An Equivalent Parallel Randomized Control Trial [NCT04061265] | Phase 1/Phase 2 | 184 participants (Actual) | Interventional | 2019-08-25 | Completed |
Prospective, Randomized Trial of Hemospray Plus Epinephrine Injection Versus Endoscopic Hemoclip Plus Epinephrine Injection in Nonvariceal Upper Gastrointestinal Bleeding [NCT02537353] | Phase 4 | 40 participants (Anticipated) | Interventional | 2015-09-30 | Not yet recruiting |
Study of Tramadol Addiction Impact on Dental Anesthesia Succes. [NCT05908305] | Phase 4 | 300 participants (Anticipated) | Interventional | 2023-06-10 | Not yet recruiting |
Electromechanical Profiling of Arrhythmogenic Substrates and Triggers in the Long-QT Syndrome [NCT04074122] | | 150 participants (Anticipated) | Observational | 2020-01-01 | Not yet recruiting |
Vasopressin, Epinephrine, and Corticosteroids for Inhospital Cardiac Arrest: A Multicenter Randomized Controlled Trial [NCT00729794] | Phase 3 | 300 participants (Actual) | Interventional | 2008-09-30 | Completed |
A Multicenter Double-Blind Randomized Placebo Controlled Two-Arm Study Evaluating the Safety and Efficacy of the Iontophoretic Administration of Lidocaine and Epinephrine Using Lidocaine Iontophoretic Drug Delivery System (IDDS) to Provide Local Anesthesi [NCT00889642] | Phase 2 | 90 participants (Anticipated) | Interventional | 2009-05-31 | Completed |
Mechanisms of Hypoglycemia Associated Autonomic Failure [NCT00678145] | Phase 2 | 116 participants (Anticipated) | Interventional | 2008-03-31 | Active, not recruiting |
Fractional CO2 Laser Assisted Topical Articaine Anesthesia vs. Topical EMLA Administration: a Randomized Controlled Study [NCT02548533] | Phase 4 | 3 participants (Actual) | Interventional | 2015-06-30 | Terminated(stopped due to Not enough patients eligible for recruitment.) |
Evidence of Spreading Vasoconstriction in Human Gingiva [NCT04131283] | | 29 participants (Actual) | Interventional | 2019-05-01 | Completed |
Shamrock - Ultrasound/MR Image Fusion Guided Lumbar Plexus Block [NCT02718976] | Phase 2 | 22 participants (Actual) | Interventional | 2016-03-31 | Completed |
Efficacy and Safety of Percutaneous Superselective Adrenal Arterial Embolization in the Treatment of Primary Aldosteronism With Bilateral Idiopathic Hyperaldosteronism: A Prospective Cohort Study [NCT05186675] | | 50 participants (Anticipated) | Interventional | 2022-01-01 | Enrolling by invitation |
Comparison of the Efficacy of Irrigation With Epinephrine or Tranexamic Acid on Visual Clarity During Arthroscopic Rotator Cuff Repair: A Randomized Double-Blind Study [NCT04628676] | | 100 participants (Actual) | Interventional | 2017-02-01 | Completed |
The Effects of Epinephrine in Endotoxemia in Normal Volunteers [NCT00753402] | Phase 1 | 37 participants (Actual) | Interventional | 2012-02-29 | Completed |
Anesthetic Efficacy of %4Alexadricaine Versus %2 Mepicaine-L for Infiltration Anesthesia in Extraction of Maxillary First Primary Molars in Children [NCT04477317] | Phase 3 | 10 participants (Actual) | Interventional | 2021-08-01 | Completed |
Adrenal Venous Sampling in Patients With Overt or Subclinical Cushings Syndrome, and Bilateral Adrenal Tumors [NCT02543697] | | 30 participants (Anticipated) | Interventional | 2015-02-28 | Recruiting |
Periarticular Injection and Hamstring Block Versus Placebo for Pain Control in Anterior Cruciate Ligament Reconstruction: A Randomized Controlled Trial [NCT05248724] | | 44 participants (Actual) | Interventional | 2017-08-01 | Completed |
The Use of Epinephrine Infusion for Prophylaxis Against Maternal Hypotension During Cesarean Delivery: a Randomized Controlled Dose-finding Trial [NCT05051150] | Phase 4 | 18 participants (Actual) | Interventional | 2021-09-15 | Terminated(stopped due to tachycardia and arrhythmia in the high doses groups 0.05 and 0.07 necessitate stopping the infusion) |
An Open-label, 8-Week Study to Compare the Comfort and Ease of Use of Five Different Treatment Regimens for CNTX-4975-05 Intra-articular Injection in Subjects With Chronic, Moderate-to-Severe Osteoarthritis Knee Pain [NCT03661996] | Phase 3 | 854 participants (Actual) | Interventional | 2018-09-18 | Completed |
Prospective Evaluation of Topical Analgesia Using a Lidocaine/Prilocaine Cream for Laceration Repair in the Emergency Department [NCT03071601] | Phase 4 | 132 participants (Actual) | Interventional | 2017-12-01 | Completed |
Surgery of Subclinical Cortisol Secreting Adrenal Incidentalomas [NCT02364089] | | 78 participants (Actual) | Interventional | 2015-04-09 | Completed |
Effect of Chronic Catecholamine Overproduction on Brown Adipose Tissue [NCT01949714] | | 10 participants (Actual) | Observational | 2013-08-31 | Completed |
Buffered vs. Unbuffered Local Anesthesia in Mandibular Molars Diagnosed With Symptomatic Irreversible Pulpitis: A Controlled, Randomized Double-blind Study [NCT05227300] | Phase 4 | 40 participants (Anticipated) | Interventional | 2022-02-14 | Recruiting |
The Hemostatic and Hemodynamic Effects of Adrenaline During Endoscopic Sinus Surgery: Randomized Clinical Trial [NCT00852410] | Phase 3 | 140 participants (Anticipated) | Interventional | 2009-03-31 | Not yet recruiting |
Epinephrine, Dexamethasone, and Hypertonic Saline in Children With Bronchiolitis in the Hospital General Naval de Alta Especialidad. A Randomized Controlled Trial [NCT02585531] | Phase 2 | 100 participants (Anticipated) | Interventional | 2015-11-30 | Not yet recruiting |
Pharmacokinetic Interaction Effects of Combined Fentanyl and Adrenalin in Epidural Analgesia During Child Birth [NCT00685672] | Phase 4 | 40 participants (Actual) | Interventional | 2008-08-31 | Completed |
Duration of Blockade of Peripheral Nerves With Low Concentrated Bupivacaine Solution Depending of the Adjuvants [NCT04498923] | | 68 participants (Actual) | Observational | 2018-01-01 | Completed |
A Randomized, Phase 4 Study of the Efficacy, Safety, and Pharmacokinetics of Bupivacaine Administered as Liposomal Bupivacaine or Continuous Infusion Via Elastomeric Pump Following Unilateral Open Inguinal Herniorrhaphy [NCT04102267] | Phase 4 | 32 participants (Actual) | Interventional | 2018-07-02 | Completed |
"Clinical Trial Protocol of Primary Study on Efficacy and Safety of Telesurgery for Patients With Tumors of the Urinary System Using Chinese Independently Developed MicroHand Surgical Robot System" [NCT04570176] | | 1 participants (Actual) | Interventional | 2020-08-27 | Completed |
Intraoperative Angiotensin 2 for the Prevention of Kidney Injury After Liver Transplant [NCT04592744] | Phase 4 | 30 participants (Anticipated) | Interventional | 2022-04-08 | Enrolling by invitation |
A Randomized Double Blind Trial of Vasoactive Drugs for the Management of Shock in the ICU [NCT02118467] | Phase 4 | 836 participants (Anticipated) | Interventional | 2014-05-31 | Recruiting |
Prospective, Multicenter, Randomized, Double-Blind Study Comparing Safety and Efficacy of Norepinephrine Plus Dobutamine Versus Epinephrine Alone in Septic Shock. [NCT00148278] | Phase 2/Phase 3 | 330 participants (Actual) | Interventional | 1999-10-31 | Completed |
Nebulized Adrenalin and Oral Betamethasone in Children With Bronchiolitis Attending Pediatric Emergencies : a Multicentre Randomized Controlled Trial [NCT02586961] | Phase 2/Phase 3 | 195 participants (Actual) | Interventional | 2015-10-31 | Terminated(stopped due to Removal of Adrénaline lots for safety reasons.) |
7% Hypertonic Saline for Acute Bronchiolitis: A Randomized Controlled Trial [NCT01871857] | Phase 4 | 101 participants (Actual) | Interventional | 2010-11-30 | Completed |
Comparative Evaluation of Handling Characteristics of Two Adrenaline Autoinjectors,EpiPen in Comparison With Jext; the HEJ-study [NCT01887405] | Phase 4 | 91 participants (Actual) | Interventional | 2012-01-31 | Completed |
Assessment of the Operative Course in Connection With Removal of Lower Third Molars With Particular Consideration to the Occurence of Pain and Swelling [NCT00805298] | | 154 participants (Actual) | Interventional | 2008-08-31 | Completed |
Bronchiolitis All-study, SE-Norway What is the Optimal Inhalation Treatment for Children 0-12 Months With Acute Bronchiolitis? [NCT00817466] | Phase 4 | 500 participants (Anticipated) | Interventional | 2010-01-31 | Active, not recruiting |
The Effects of Epinephrine and Cortisol on Emotion in Depression [NCT04148261] | Early Phase 1 | 0 participants (Actual) | Interventional | 2020-12-31 | Withdrawn(stopped due to Principal Investigator left lab before study start) |
Nebulized 5% Hypertonic Saline for Infirmary Treatment of Acute Infant Bronchiolitis: A Randomized Trial [NCT01016249] | Phase 4 | 187 participants (Actual) | Interventional | 2007-04-30 | Completed |
High Flow Therapy vs Hypertonic Saline in Bronchiolitis Treatment. Randomized Controlled Trial [NCT01873144] | Phase 3 | 75 participants (Actual) | Interventional | 2010-10-31 | Completed |
The Efficacy of Analgesic Buffering With Sodium Bicarbonate for the Pediatric Dental Patient [NCT01883232] | | 0 participants (Actual) | Interventional | 2013-08-31 | Withdrawn |
Phase 2, Single-Center, Placebo-Controlled Study of the Effects of Combined Administration of Vasopressin, Methylprednisolone, and Epinephrine During Cardiopulmonary Resuscitation on Survival After Cardiac Arrest [NCT00411879] | Phase 2 | 100 participants (Actual) | Interventional | 2006-06-30 | Completed |
An Ultrasound Guided Fascia Iliaca Block Placed at the Level of the Inguinal Ligament for Analgesia After Hip Arthroplasty [NCT01911949] | | 24 participants (Actual) | Interventional | 2017-01-31 | Completed |
Anesthetic Efficacy of 4% Articaine (Mandibular Infiltration) and 2% Lidocaine (Alveolar Nerve Block), Associated With 1:100.000 Epinephrine, in Lower Molars With Irreversible Pulpits [NCT01912755] | Phase 4 | 50 participants (Actual) | Interventional | 2010-02-28 | Completed |
Effect of Preventive Medicine on the Postreperfusion Syndrome [NCT01080625] | | 96 participants (Actual) | Interventional | 2010-04-30 | Completed |
Efficiency of Multi-Modal Anesthesia (MMA) Protocol in Pain Control and Analgesia in Patients Undergoing Posterior Lumbar Spinal Fusion Surgery [NCT05413902] | Phase 4 | 100 participants (Actual) | Interventional | 2021-04-05 | Completed |
Compare Articaine 1:100.000, 4% Epinephrine, Subperiosteal With Loco-regional Anesthesia for Placing Dental Implants in Posterior Mandible - Double-Blinded Randomized Clinical Trial [NCT01963754] | Phase 4 | 88 participants (Anticipated) | Interventional | 2017-04-01 | Active, not recruiting |
Phase 4 Study of Comparison of Preincisional Infiltrated Dexmedetomidine and Lidocaine Plus Adrenaline for Surgical Conditions and Postoperative Analgesic Consumption in Nasal Sephoplasty Surgery. [NCT01964586] | Phase 4 | 60 participants (Actual) | Interventional | 2013-03-31 | Completed |
The Effect of Topical Administration of Tranexamic Acid, Adrenaline and Bupivacain on Postoperative Bleeding and Pain in Patients Undergoing Breast Surgery. A Four-armed Placebo-controlled Double Blinded Randomized Study [NCT01964781] | Phase 4 | 30 participants (Actual) | Interventional | 2013-08-31 | Completed |
An Evaluation of Post Caesarean-Section Pain Control Regimens: Non-Opioid Oral Regimen With and Without Transversus Abdominis Plane Block [NCT01982929] | | 180 participants (Actual) | Interventional | 2013-11-30 | Completed |
Can we Gain an Advantage by Combining Distal Median, Radial and Ulnar Nerve Blocks With Supraclavicular Block? A Randomized Controlled Study [NCT01989312] | Phase 4 | 75 participants (Actual) | Interventional | 2012-02-29 | Completed |
Does Saphenous Nerve Block Improve Analgesia After Total Knee Replacement When Used in Combination With Local Infiltration Analgesia? A Prospective Randomised Double Blinded Trial. [NCT01991288] | Phase 4 | 20 participants (Actual) | Interventional | 2012-11-30 | Completed |
Regional Anesthesia Block of the Transversus Abdominis Plane in Children Undergoing Gastric Tube Insertion [NCT00564655] | Phase 3 | 3 participants (Actual) | Interventional | 2007-10-31 | Terminated |
Efficacy of Hemostasis by Soft Coagulation Using Endoscopic Hemostatic Forceps in Comparison With Argon Plasma Coagulation for Acute Peptic Ulcer Bleeding [NCT02020603] | | 151 participants (Actual) | Interventional | 2012-01-31 | Completed |
Effects of Adrenaline Infiltration on Surgical Field of View in Endoscopic Sinus Surgery [NCT05867342] | Phase 4 | 40 participants (Actual) | Interventional | 2017-05-12 | Completed |
The Effect of Oral Midodrine Versus Oral Desmopressin Acetate Use for Liberation From IV Noradrenaline in Intensive Care Unit Patients Recovering From Spinal Shock . [NCT04586790] | Phase 2 | 90 participants (Anticipated) | Interventional | 2020-10-15 | Recruiting |
Comparison Between Effect of Adrenaline and Without Adrenaline in Tumescent Solutions on Bleeding Control of Skin Graft Donor Site. [NCT04590638] | | 56 participants (Actual) | Interventional | 2020-10-17 | Completed |
Comparison of Ropivacaine Plasma Concentration With or Without Epinephrine for Posterior Quadratus Lumborum Block in Cesarean Section [NCT04562103] | | 52 participants (Actual) | Interventional | 2020-07-03 | Completed |
A Randomised, Open Label Study to Compare the Efficacy of Nor Adrenaline and Terlipressin vs Step up Terlipressin Therapy in Hepatorenal Syndrome [NCT01649037] | | 0 participants (Actual) | Interventional | 2012-08-31 | Withdrawn(stopped due to lack of funds) |
Topical Adrenaline Versus Warm Saline Solution for Minimizing Intraperitoneal Bleeding During Caesarian Delivery for Placenta Previa / Accreta Spectrum ( PAS): A Randomized Controlled Study [NCT06030479] | | 84 participants (Anticipated) | Interventional | 2023-02-01 | Recruiting |
Randomized, Double-Blind, Placebo-Controlled Study of Effects of Combined Spinal Epidural Analgesia on Intrapartum Fever. [NCT00802646] | | 0 participants (Actual) | Interventional | 2009-06-30 | Withdrawn(stopped due to study moved to alternate site) |
Ultrasound Guided Motor Sparing Knee Blocks With or Without Dexmedetomidine for Postoperative Analgesia Following Knee Arthroplasty: a Randomized Double Blinded Study [NCT02540070] | Phase 3 | 135 participants (Anticipated) | Interventional | 2014-08-31 | Recruiting |
Prophylactic Racemic Epinephrine for the Prevention of Dysphagia in Patients Undergoing Anterior Cervical Discectomy and Fusion: A Randomized Control Trial [NCT02724761] | | 90 participants (Anticipated) | Interventional | 2016-09-30 | Not yet recruiting |
A Prospective Randomized Case Series Comparison on the Clinical Efficacy of Exparel Local Anesthetic in Total Knee Arthroplasty Patients [NCT02765815] | Phase 4 | 0 participants (Actual) | Interventional | 2016-02-29 | Withdrawn(stopped due to competing protocol) |
An Parallel Control Clinical Trail on Effects of Adrenal Artery Ablation and Adrenalectomy in Patients With Primary Aldosteronism [NCT04269928] | | 60 participants (Anticipated) | Interventional | 2016-01-19 | Recruiting |
The Effect of Subsartorial Saphenous Block on Postoperative Pain Following Major Ankle and Hind Foot Surgery [NCT02697955] | Phase 4 | 18 participants (Actual) | Interventional | 2016-06-21 | Completed |
[NCT02860221] | | 210 participants (Anticipated) | Interventional | 2015-05-31 | Recruiting |
Ophthalmic Artery Resistance Index After Peribulbar Block in the Presence of Epinephrine [NCT04153123] | | 26 participants (Actual) | Interventional | 2013-12-01 | Completed |
Topical Use of Tranexamic Acid Versus Epinephrine to Optimize Surgical Field During Exploratory Tympanotomy [NCT04188184] | | 60 participants (Actual) | Interventional | 2019-12-04 | Completed |
Comparison of the Analgesic Effect of the Local Anesthetics Ropicacaine, Levobupivacaine, and Levobupivacaine + Epinephrin Via Interscalene Nerve Block in Patients Undergoing Shoulder Arthroscopy Under General Anesthesia [NCT02691442] | Phase 4 | 30 participants (Actual) | Interventional | 2010-12-31 | Completed |
Comparison of the Efficacy and Safety of Two Homologous Active Principles for Local Dental Anesthesia: Non-inferiority Trial [NCT04166890] | Phase 4 | 179 participants (Actual) | Interventional | 2018-09-04 | Completed |
Local Infiltration Analgesia (LIA) With Ropivacaine, Ketorolac and Epinephrine Intra- and Postoperatively in Unicompartmental Knee Arthroplasty [NCT00653926] | | 40 participants (Actual) | Interventional | 2005-09-30 | Completed |
Protective Analgesia Using Bupivacaine and Conventional Release Ibuprofen Versus Bupivacaine and Sustained Release Ibuprofen for Postoperative Pain Relief in Patients Undergoing Third Molar Surgery: a Randomised Controlled Trial [NCT00895843] | | 122 participants (Actual) | Interventional | 2006-11-30 | Completed |
An Assessment of the Effects of Pressors on Graft Blood Flow After Free Tissue Transfer Surgery: A Randomised Study [NCT01418118] | Phase 4 | 25 participants (Actual) | Interventional | 2008-10-31 | Completed |
Comparison of Absorption of Epinephrine Into the Circulation After Epinephrine Intranasal Spray Administration and After Intramuscular Injection [NCT01432522] | | 12 participants (Anticipated) | Interventional | 2010-07-31 | Completed |
Pectoral Nerve (PECS) Block for Cardiac Implantable Electronic Devices (CIED) Implantation Surgery [NCT04577690] | Phase 4 | 48 participants (Anticipated) | Interventional | 2019-12-01 | Recruiting |
Prophylactic Tranexamic Acid Versus Adrenaline for Bleeding Prevention During Flexible Bronchoscopy: a Double Blind, Randomized Controlled Trial [NCT06145191] | | 840 participants (Anticipated) | Interventional | 2023-12-18 | Recruiting |
Assessment and Evaluation of Pharmacokinetic Profile of E004 in Healthy Adults (A Randomized, Evaluator-Blind, Single-Dose, Two Arm, Crossover, PK Study in Healthy Volunteers) [NCT01737892] | Phase 1/Phase 2 | 21 participants (Actual) | Interventional | 2012-11-30 | Terminated(stopped due to unable to validate analytical method) |
"The Efficacy of Exparel Versus a Multidrug Cocktail in Soft Tissue Tumors" [NCT05355597] | Phase 2 | 140 participants (Anticipated) | Interventional | 2021-01-27 | Recruiting |
Effect of Local Infiltration Anesthesia With Ropivacaine on Postoperative Pain After Hip Hemiarthroplasty [NCT02585011] | | 123 participants (Actual) | Interventional | 2015-12-31 | Completed |
Myocardial Deformation Before and After Birth, and Under Altered Preload, Afterload and Heart Rate in New-borns [NCT04060381] | | 300 participants (Anticipated) | Observational | 2017-04-04 | Active, not recruiting |
Comparing the Hemodynamic Effects of Epinephrine Versus Dexmedetomidine as an Adjuvant to Bupivacaine in Caudal Anaesthesia Assessed by Cardiometry: a Randomized, Double-blind, Controlled Study [NCT05860010] | | 39 participants (Anticipated) | Interventional | 2023-06-05 | Not yet recruiting |
Subacromial Injection of Epinephrine Improves Visualization in Shoulder Arthroscopy [NCT05244525] | Phase 4 | 60 participants (Actual) | Interventional | 2022-03-14 | Completed |
Use of Vasopressin Versus Epinephrine to Reduce Hemorrhage During Myomectomy: a Randomized Controlled Trial [NCT01861015] | Phase 3 | 60 participants (Actual) | Interventional | 2013-05-31 | Completed |
Fluid Management in Patients Undergoing Cardiac Surgery - Effects of an Acetate Versus Lactate Buffered Balanced Infusion Solution on Hemodynamic Stability, a Randomized Controlled Double-blind Trial [NCT02895659] | Phase 4 | 150 participants (Actual) | Interventional | 2016-12-01 | Completed |
Evaluation of Two Approaches in Enhancing the Efficacy of Inferior Alveolar Nerve Block During Treatment of Mandibular First Permanent Molars With Symptomatic Irreversible Pulpitis: A Randomized Parallel Controlled Trial [NCT05427903] | | 180 participants (Anticipated) | Interventional | 2022-03-04 | Recruiting |
Pharmacokinetics and Pharmacodynamics for Levobupivacaine With and Without Epinephrine After Ultrasound Guided Erector Spinae Plane Block [NCT04799184] | Phase 4 | 38 participants (Anticipated) | Interventional | 2019-04-03 | Recruiting |
Postoperative Pain Control Using Local Wound Infiltration in Adolescent Idiopathic Surgery: A Randomized Control Trial [NCT04730531] | | 100 participants (Anticipated) | Interventional | 2022-06-02 | Recruiting |
Low-dose Epinephrine Infusion Tests in Adolescent and Pediatric Patients [NCT00548886] | | 7 participants (Actual) | Interventional | 2008-02-29 | Terminated(stopped due to Lack of enrollment) |
Over-the-scope Clips and Standard Treatments in Endoscopic Control of of Acute Bleeding From Non-variceal Upper GI Causes(OTSC Study) [NCT03216395] | | 191 participants (Actual) | Interventional | 2018-01-02 | Completed |
Use of Percutaneously-Placed Continuous Flow Bupivacaine Pain Pumps to Decrease Post-operative Pain Following Mastectomy With Immediate Reconstruction: A Prospective, Randomized, Double-Blind Clinical Trial [NCT01494259] | Phase 4 | 0 participants (Actual) | Interventional | 2016-01-31 | Withdrawn |
Efficacy of Intracoronary Adrenaline and Its Comparison With Intracoronary Adenosine in the Treatment of No-Reflow in Normotensive Patients With Acute Coronary Syndrome [NCT04699110] | Phase 4 | 201 participants (Actual) | Interventional | 2021-01-01 | Completed |
Adrenal Scans With Radioiodine-Labeled Norcholesterol (NP-59) [NCT00591643] | Phase 1 | 93 participants (Actual) | Interventional | 1977-07-31 | Completed |
Comparison the Effect of Lidocaine (With Epinephrine) With and Without Sufentanil on the Rate of Anesthesia of Intra-ligamentary Injection in Teeth With Irreversible Pulpitis [NCT01572116] | Phase 2 | 60 participants (Actual) | Interventional | 2010-01-31 | Completed |
Maternal-Fetal Monitoring of Patients With Rheumatic Heart Disease During Dental Procedure Under Local Anesthesia [NCT00482573] | Phase 1 | 31 participants (Actual) | Interventional | 2004-04-30 | Completed |
Evaluating the Effectiveness of Local Multimodal Injection in Controlling Pain, Limiting Complications, and Reducing Cost as Compared to Regional Anesthesia for Treating Rotational Ankle Fractures. [NCT05019638] | Early Phase 1 | 200 participants (Anticipated) | Interventional | 2021-05-15 | Enrolling by invitation |
Comparative Effect of Palatal Injection on Pain Perception in Pediatric Patient [NCT06025825] | | 96 participants (Anticipated) | Observational [Patient Registry] | 2023-05-02 | Recruiting |
Epinephrine Versus Phenylephrine Infusion for Prophylaxis Against Maternal Hypotension After Spinal Anesthesia for Cesarean Delivery: a Randomized Controlled Trial. [NCT05881915] | | 196 participants (Anticipated) | Interventional | 2023-06-01 | Recruiting |
Intercostal Cryoneurolysis Following Traumatic Rib Fractures [NCT04198662] | Phase 4 | 20 participants (Actual) | Interventional | 2020-04-03 | Active, not recruiting |
Parameters in Fractional Laser Assisted Delivery of Topical Anesthetics: Role of Laser Type and Laser Settings [NCT02938286] | Phase 4 | 15 participants (Actual) | Interventional | 2016-03-31 | Completed |
A Prospective, Multicenter, Single-blind, Controlled Clinical Trial to Confirm the Efficacy and Safety of 'UI-EWD', a Wound Dressing Used for Wound Protection and Hemostasis After Ulcer Bleeding Due to Peptic Ulcer, EMR and ESD [NCT02978391] | | 76 participants (Actual) | Interventional | 2016-05-23 | Completed |
Cardiovascular Effects of Racemic Epinephrine Pellets Used in Pediatric Restorative Dentistry Under General Anesthesia [NCT04688346] | Phase 2/Phase 3 | 13 participants (Actual) | Interventional | 2019-06-10 | Completed |
Efficacy of Perioperative US-Guided Serratus Anterior Plane Block Versus Thoracic Epidural in Adult Patient Undergoing Thoracotomy: A Randomized Comparative Double-Blinded Trial [NCT05672394] | | 74 participants (Actual) | Interventional | 2021-06-01 | Completed |
The Use of Lidocaine Ophtesic Gel Versus Subconjunctival Xylocaine Injection in Pterygium Excision [NCT05978687] | Phase 4 | 50 participants (Anticipated) | Interventional | 2023-09-01 | Recruiting |
A Randomized Controlled Trial Comparing Epinephrine and Dexamethasone to Placebo in the Treatment of Infants With Bronchiolitis [NCT03567473] | Phase 3 | 864 participants (Anticipated) | Interventional | 2018-12-13 | Recruiting |
Hemodynamics and Extravascular Lung Water in Acute Lung Injury: A Prospective Randomized Controlled Multicentered Trial of Goal Directed Treatment of EVLW Versus Standard Management for the Treatment of Acute Lung Injury [NCT00624650] | Phase 2 | 33 participants (Actual) | Interventional | 2008-02-29 | Completed |
A Phase 3, Multicenter, Randomized, Double-blind Parallel-group, Active-control Study to Evaluate the Safety and Efficacy of Local Administration of SKY0402 for Prolonged Postoperative Analgesia in Subjects Undergoing Bilateral, Cosmetic Sub-muscular Brea [NCT00813111] | Phase 3 | 136 participants (Actual) | Interventional | 2008-11-30 | Terminated(stopped due to Sponsor decision, unrelated to safety) |
Multicenter Randomized Controlled Trial of Gastric Endoscopic Submucosal Dissection With or Without Epineprhine Added Solution [NCT04032119] | Phase 3 | 800 participants (Actual) | Interventional | 2020-01-10 | Completed |
Acoustic Assessment of Nebulized Epinephrine Versus Albuterol for RSV Bronchiolitis- a Double Blind Study [NCT00361452] | Phase 4 | 30 participants | Interventional | 2000-12-31 | Terminated |
Effect of Dexmedetomidine as Adjuvant to Ropivacaine for Brachial Plexus Block [NCT05767827] | | 40 participants (Anticipated) | Interventional | 2023-02-01 | Recruiting |
Effects of Epinephrine and I.V. Needle on CPR Outcome [NCT00121524] | Phase 2 | 904 participants (Actual) | Interventional | 2003-01-31 | Completed |
Can the Risk of RD and Hypoglycemia in Children Born at Elective CS be Reduced by Injection of Adrenaline [NCT00322660] | | 270 participants (Actual) | Interventional | 2006-06-30 | Completed |
A Phase 2B, Randomized, Double Blind, Active Comparator, Multicenter, Safety, and Efficacy Trial of ATX-101 in Subjects Undergoing Total Knee Arthroplasty [NCT05260008] | Phase 2 | 305 participants (Anticipated) | Interventional | 2022-06-07 | Recruiting |
Parameters in Fractional Laser Assisted Delivery of Topical Anesthetics: Role of Anesthetic and Application Time [NCT03279757] | Phase 4 | 15 participants (Actual) | Interventional | 2016-10-01 | Completed |
Phase 3 Study of Adrenaline and Milrinone in Patients With Myocardial Dysfunction [NCT00446017] | Phase 3 | 60 participants | Interventional | 2003-06-30 | Completed |
Randomized Controlled Trial Examining the Effect of Subcutaneous Xylocaine 2% on the Incidence of Vasovagal Reactions and Pain Intensity During Femoral Artery Sheath Removal. [NCT00465439] | | 78 participants (Actual) | Interventional | 2007-05-31 | Completed |
Comparison of Epinephrine Associated With Vasopressin vs Epinephrine Alone in the Treatment of Out-of-Hospital Cardiac Arrests [NCT00127907] | Phase 4 | 2,416 participants | Interventional | 2004-05-31 | Completed |
Effect of Adrenaline Concentration in Tumescence Solution on Intraoperative Hemodynamics of Liposuction Patients: A Randomized Controlled Trial [NCT05822765] | Phase 3 | 40 participants (Actual) | Interventional | 2023-05-01 | Completed |
Neosaxitoxin (NeoSTX) Alone and in Combination With Bupivacaine as Prolonged Duration Local Anesthetics: A Phase I Investigator-initiated Dose Escalation Study [NCT01786655] | Phase 1 | 105 participants (Actual) | Interventional | 2013-05-31 | Completed |
Selective Trunk Block Versus Hybrid Interscalene-Supraclavicular Brachial Plexus Block for Anaesthesia of the Entire Upper Extremity: A Randomized Double-Blind Controlled Trial [NCT04908371] | | 0 participants (Actual) | Interventional | 2022-12-31 | Withdrawn(stopped due to Published data indicated Selective Trunk Block is a better choice) |
Intracoronary Administration of Epinephrine and Verapamil in the Refractory No-reflow Phenomenon in Patients With Acute Myocardial Infarction: The EPIVER Randomized Controlled Trial [NCT04573751] | | 104 participants (Actual) | Interventional | 2020-12-30 | Active, not recruiting |
Randomized Trial of Transversus Abdominal Plane (TAP) Block at Total Laparoscopic Hysterectomy: Effect of Regional Analgesia on Quality of Recovery [NCT01479270] | | 56 participants (Actual) | Interventional | 2011-05-31 | Completed |
Phase I/II Study Epinephrine Inhalation Aerosol USP, an HFA-MDI Clinical Study-B for Assessment of Pharmacokinetics [NCT01143051] | Phase 1/Phase 2 | 24 participants (Actual) | Interventional | 2010-01-31 | Completed |
Determining the Role of Periarticular Multimodal Analgesia in Decreasing Perioperative Pain in Tibial Plateau Fractures [NCT05037812] | Early Phase 1 | 150 participants (Anticipated) | Interventional | 2019-03-25 | Active, not recruiting |
Post-Caesarean Section Incisional Infiltration With Lidocaine Versus Lidocaine and Epinephrine;Randomized Controlled Trial. [NCT02274974] | Phase 4 | 160 participants (Actual) | Interventional | 2014-08-31 | Completed |
A Comparative Study for Evaluation of the Analgesic Profile of Ultrasound-Guided Modified Pectoral Nerves Block Versus Serratus Plane Block in Major Breast Cancer Surgery [NCT02946294] | Phase 2 | 90 participants (Actual) | Interventional | 2016-10-31 | Completed |
Liposomal Bupivacaine Versus Bupivacaine for Postoperative Analgesia Following Video-assisted Thoracoscopic Surgery. [NCT03036085] | Phase 2/Phase 3 | 200 participants (Anticipated) | Interventional | 2017-02-28 | Not yet recruiting |
Endoscopic Ultrasound-guided Radiofrequency Ablation as a Novel Treatment Option Compared With Adrenalectomy in Left-sided Primary Aldosteronism [NCT05368090] | | 40 participants (Anticipated) | Interventional | 2022-06-03 | Recruiting |
A Prospective Randomized Comparison of the Effects of Lidocaine and Levobupivacaine on Block Dynamics After a Subparaneural Popliteal Sciatic Nerve Block [NCT04397484] | Phase 4 | 40 participants (Anticipated) | Interventional | 2023-09-20 | Recruiting |
Effect of Epinephrine on Systemic Absorption of Mepivacaine Administered for Brachial Plexus Block in Patients With Chronic Renal Insufficiency [NCT01533545] | | 16 participants (Actual) | Interventional | 2012-09-30 | Terminated(stopped due to Slow recruitment) |
Articaine Efficacy and Safety for 3 Years Old Children: A Clinical Randomized Control Trial [NCT05839548] | Phase 3 | 200 participants (Anticipated) | Interventional | 2023-06-01 | Not yet recruiting |
Randomized Controlled Trial of Epinephrine and Albuterol in Bronchiolitis [NCT00114478] | | 600 participants | Interventional | 2003-11-30 | Active, not recruiting |
Comparison of Infraclavicular and Supraclavicular Block Approaches in Ultrasound Guided Brachial Plexus Block [NCT04784104] | Phase 4 | 70 participants (Anticipated) | Interventional | 2021-03-05 | Not yet recruiting |
Prospective Comparison of Epinephrine and Phenylephrine/Ketorolac (Omidria®) Additives With Regards to Intraoperative Pupil Size [NCT02895035] | Phase 4 | 59 participants (Actual) | Interventional | 2016-09-01 | Terminated(stopped due to Data analysis was never performed by sub-investigator) |
Subcutaneous Injection of Large Volumes of Tumescent Lidocaine and Epinephrine (TLE) by Laypersons: a Double-blind, Non-inferiority, Randomized Clinical Trial [NCT04733781] | Phase 2/Phase 3 | 36 participants (Anticipated) | Interventional | 2021-02-22 | Not yet recruiting |
Trigger Finger Corticosteroid Injection With and Without Local Anesthetic; a Randomized, Double Blind Controlled Trial [NCT04023695] | Phase 4 | 110 participants (Actual) | Interventional | 2017-10-01 | Completed |
Propofol-dexmedetomidine Versus Propofol-remifentanil Conscious Sedation for Awake Craniotomy During Epilepsy Surgery [NCT02988050] | | 60 participants (Actual) | Interventional | 2013-08-31 | Completed |
Effect of Epinephrine on Immediate Post-polypectomy Pain in Colorectal Lesions Larger Than 20 mm [NCT04065451] | Phase 4 | 22 participants (Actual) | Interventional | 2020-01-06 | Completed |
Prospective, Randomized Study on Two Parallel Groups Comparing Dopexamine and Norepinephrine in Combination to Epinephrine Alone on Systemic and Pulmonary Hemodynamics, Gastric Mucosal Perfusion, and Oxidative Stress in Septic Shock [NCT00134212] | Phase 2 | 20 participants | Interventional | 2002-03-31 | Completed |
[NCT00225043] | | 60 participants (Actual) | Interventional | 2005-06-30 | Completed |
A Randomised, Double-blinded Multi-centre Trial Comparing Vasopressin and Adrenaline in Patients With Cardiac Arrest at the Emergency Department. (Preadmission Intravenous Vasopressin, Adrenaline Outcome Trial: PIVOT vII) [NCT00358579] | Phase 3 | 727 participants (Actual) | Interventional | 2006-03-31 | Completed |
Analgesic Efficacy of a Combination of Fentanyl and Lidocaine for Maxillary Infiltration in Teeth With Irreversible Pulpitis [NCT01794533] | Phase 2 | 64 participants (Actual) | Interventional | 2012-10-31 | Completed |
A Randomized Comparison Between Single- and Double-injection Ultrasound-Guided Costoclavicular Block [NCT03595514] | | 90 participants (Anticipated) | Interventional | 2018-07-30 | Recruiting |
Peri-articular Injections Containing a Corticosteroid During Total Knee Arthroplasty [NCT00492973] | | 101 participants (Actual) | Interventional | 2006-03-31 | Completed |
Surgical Treatment of Carpal Tunnel Syndrome: Local Anesthesia With Epinephrine x Intravenous Regional Anesthesia. Randomized Clinical Trial. [NCT02986347] | | 78 participants (Actual) | Interventional | 2017-05-27 | Completed |
Vasopressin vs. Epinephrine During Neonatal Cardiopulmonary Resuscitation - a Cluster Randomized Controlled Phase I Trial [NCT05738148] | Phase 1 | 20 participants (Anticipated) | Interventional | 2023-11-27 | Recruiting |
Effect of Lidocaine and Adrenaline Soaked Gauze Versus Normal Saline Soaked at Skin Graft Donor Site of Thigh: A Randomized Control Trial [NCT04344483] | | 60 participants (Actual) | Interventional | 2019-12-10 | Completed |
Goal-Directed Intraoperative Fluid Management Using FloTrac© Monitoring in High-Risk Neurosurgical Patients [NCT02701582] | | 66 participants (Actual) | Interventional | 2014-03-31 | Completed |
Decision Support for Intraoperative Low Blood Pressure [NCT02726620] | | 22,435 participants (Actual) | Interventional | 2017-01-05 | Completed |
Does the Choice of Perioperative Inotropes Has Influence on the Morbidity and Mortality of Infants Operated for Complex Heart Defects? [NCT04380181] | | 250 participants (Actual) | Observational | 2020-05-11 | Completed |
Efficacy of Multimodal Perioperative Analgesia Protocol With Periarticular Drug Injection in Total Knee Arthroplasty: A Randomized, Double Blind Study [NCT01042093] | | 160 participants (Actual) | Interventional | 2010-01-31 | Completed |
Comparison of Topical Vasoconstriction in Endoscopic Sinus Surgery: Cocaine Versus Adrenaline [NCT01706952] | Phase 4 | 45 participants (Actual) | Interventional | 2012-12-31 | Completed |
Does Single Injection Adductor Canal Block Improve Postoperative Analgesia in Patients Receiving Periarticular Local Anesthesia Injections for Total Knee Arthroplasty? [NCT02276495] | | 55 participants (Actual) | Interventional | 2014-09-26 | Active, not recruiting |
The Effect of Intranasal Vasoconstrictor Medications on Hemodynamic Parameters: A Randomized Double-blind, Placebo-controlled Trial. [NCT02285634] | | 68 participants (Actual) | Interventional | 2014-11-30 | Completed |
Perineural Steroids for Saphenous Peripheral Nerve Blocks: An Equivalency Dosing Study. [NCT02462148] | Phase 4 | 85 participants (Actual) | Interventional | 2015-07-31 | Completed |
The Effects of Systemic Steroids on the Duration of a Psoas Compartment Block. [NCT02464176] | Phase 4 | 115 participants (Actual) | Interventional | 2015-06-30 | Completed |
Does Selective Intraoperative Administration of Local Anesthesia in Breast Reconstruction Reduce Postoperative Pain and Opioid Requirement?: A Prospective Double-Blinded Randomized Controlled Trial [NCT02525718] | Phase 2 | 47 participants (Actual) | Interventional | 2015-08-31 | Completed |
Ultrasound-guided Fascia Iliaca Compartment Block Versus Periarticular Infiltration for Pain Management After Total Hip Arthroplasty: A Randomized Controlled Trial [NCT02658240] | | 60 participants (Actual) | Interventional | 2016-04-05 | Completed |
Efficacy of Liposomal Bupivacaine Versus Standard Analgesia in Pain Management of Total Joint Arthroplasty [NCT02197273] | | 211 participants (Actual) | Interventional | 2014-07-31 | Completed |
Prospective Randomized Study Comparing Suprainguinal Fascia Iliaca Block vs. Pericapsular Nerve Group Block vs. Local Anesthetic Infiltration vs. Spinal Anesthetic Without Adjuncts for Pain Control Following Total Hip Arthroplasty [NCT05062356] | Phase 1 | 240 participants (Anticipated) | Interventional | 2021-11-04 | Recruiting |
Perioperative Analgesia for Total Hip Arthroplasty: Lumbar Plexus Block Using Shamrock Technique Versus Fascia Iliaca Block [NCT04670497] | | 70 participants (Actual) | Interventional | 2018-07-01 | Completed |
The Effect of Intranasal Irrigation With Adrenaline Solution on Intraoperative Visualization and Bleeding During Functional Endoscopic Sinus Surgery [NCT04551703] | Phase 1 | 60 participants (Actual) | Interventional | 2016-07-01 | Completed |
Comparison of 2 Application Techniques for LET (Lidocaine 4%; Epinephrine 0.1%; Tetracaine 0.5%) Gel Used Prior to Simple Laceration Repair [NCT04536493] | Phase 4 | 48 participants (Actual) | Interventional | 2019-06-19 | Completed |
Postoperative Analgesia After Total Hip Arthroplasty. A Comparison of Continuous Epidural Infusion and Wound Infiltration With Intraarticular Bolus Injection. [NCT00289419] | Phase 4 | 80 participants (Actual) | Interventional | 2005-02-28 | Completed |
Low Dose Adrenaline, Promethazine, & Hydrocortisone (Alone and in Combination) to Prevent Acute Adverse Reactions to Antivenom in People Bitten by Snakes: Randomised, Double Blind, Placebo-Controlled Trial [NCT00270777] | Phase 4 | 1,000 participants (Anticipated) | Interventional | 2005-03-31 | Completed |
Safety and Efficacy of Cocktail Periarticular Injection for Pain Management in Simultaneous Bilateral Total Knee Arthroplasty- A Prospective, Randomized Trial [NCT02270437] | Phase 4 | 55 participants (Actual) | Interventional | 2014-06-30 | Completed |
[NCT00298571] | Phase 2/Phase 3 | 100 participants (Anticipated) | Interventional | 2006-02-28 | Completed |
Buffered vs Unbuffered Local Anesthesia Using Lidocaine, Carbocaine, and Articaine in Mandibular Molars Diagnosed With Symptomatic Irreversible Pulpitis [NCT06047366] | Phase 4 | 60 participants (Anticipated) | Interventional | 2023-12-05 | Recruiting |
The Effect and Safety of Low Dose Nebulized Epinephrine in the Treatment of Croup [NCT01664507] | Phase 4 | 84 participants (Anticipated) | Interventional | 2016-01-31 | Recruiting |
Efficacy of Intraoperative Injections on Postoperative Pain Control During Total Hip Arthroplasty: A Prospective, Blinded, Randomized Controlled Study [NCT03119038] | Phase 4 | 0 participants (Actual) | Interventional | 2016-04-30 | Withdrawn(stopped due to Investigator no longer actively pursuing this study.) |
Microneedle Pretreatment as a Strategy to Improve the Effectiveness of Topical Anesthetics Formulations [NCT05267938] | Phase 1 | 30 participants (Actual) | Interventional | 2019-08-01 | Completed |
Bupivacaine Digital Blocks: How Long is the Pain Relief and Temperature Elevation? [NCT01698593] | | 44 participants (Actual) | Interventional | 2009-07-31 | Completed |
The Effect of Intraoperative Low Dose Adrenaline on Bleeding in Total Hip Arthroplasty - a Randomized Placebo-controlled Trial [NCT01708642] | Phase 3 | 106 participants (Actual) | Interventional | 2012-11-30 | Completed |
"Hemodynamic and Electrocardiographic Effects of Hyaluronidase Associated With Local Anaesthetics: a Double-blind Split-mouth Controlled Trial." [NCT01719978] | Phase 4 | 20 participants (Actual) | Interventional | 2007-10-31 | Completed |
A Prospective, Double-blinded, Randomized Comparison of Ultrasound-guided Femoral Nerve Block With Lateral Femoral Cutaneous Nerve Block Versus Standard Anesthetic Management for Traumatic Femur Fracture Repair in the Pediatric Population [NCT01759407] | Phase 2 | 19 participants (Actual) | Interventional | 2013-05-31 | Terminated(stopped due to Interim analysis showed no significant difference between study arms.) |
Comparison Between Epinephrine and Exercise Test in QT Long Syndrome Patients With KCNQ1 or KCNH2 Mutation Without Long QT Interval in Rest ECG [NCT01745666] | | 130 participants (Anticipated) | Interventional | 2012-05-31 | Recruiting |
A Randomized Single-blinded Trial of Combined Spinal-Epidural Versus Continuous Epidural Analgesia [NCT01750099] | | 202 participants (Anticipated) | Interventional | 2013-02-28 | Completed |
MCP Study, A Double-Blinded, Randomized Controlled Trial To Compare Multifidus Cervicis Plane Block (MCP) Vs. Sham Block, In Reducing Postoperative Pain And Opioid Consumption In Patients Undergoing Elective Primary Posterior Cervical Spine Fusion Surgery [NCT05996133] | Phase 4 | 38 participants (Anticipated) | Interventional | 2023-12-12 | Recruiting |
Sciatic Nerve Block for Ankle/Foot Surgeries. A Comparison Between a Premixed Solution of Lidocaine Plus Bupivacaine and Consecutive Infiltration of Lidocaine and Bupivacaine. A Double Blinded Randomised Controlled Prospective Study [NCT01756443] | Phase 4 | 40 participants (Actual) | Interventional | 2011-08-31 | Completed |
Incident and Extent of Pulse Alteration During Administration of Various Modes of Local Anesthesia in Children During Routine Dental Treatment [NCT02328729] | | 300 participants (Anticipated) | Observational | 2015-01-31 | Not yet recruiting |
Local Infiltration Analgesia After Abdominal Hysterectomy [NCT01782781] | Phase 3 | 60 participants (Actual) | Interventional | 2012-11-30 | Completed |
Autologous Fat Grafting for Pedal Fat Pad Atrophy [NCT01796808] | | 31 participants (Actual) | Interventional | 2013-03-31 | Completed |
Pilot Study: Epinephrine, Dexamethasone, and Hypertonic Saline in Children With Bronchiolitis, Randomised Clinical Trial of Efficacy and Safety [NCT01834820] | Phase 4 | 120 participants (Actual) | Interventional | 2013-01-31 | Completed |
Efficacy of Prophylactic Epinephrine Solution Injection in Prevention of Delayed Post-sphincterotomy Bleeding in Patients With Transient Bleeding During ERCP [NCT04964869] | | 400 participants (Anticipated) | Interventional | 2021-07-15 | Recruiting |
Onset and Duration of Effect of Lidocaine, Bupivacaine, and Lidocaine/Bupivacaine Mixture With Epinephrine. [NCT01243112] | Phase 4 | 25 participants (Actual) | Interventional | 2010-05-31 | Completed |
Control of Tourniquet Pain With an Axillary Ring of Subcutaneous Local Anesthetic [NCT01829399] | Phase 4 | 24 participants (Actual) | Interventional | 2013-04-30 | Completed |
A Prospective, Multicenter Study to Evaluate Effectiveness and Safety of Tymbion Iontophoresis and Tympanostomy Tube Placement Using the Tula Iontophoresis and Tube Delivery Systems for Adults in an Office Setting [NCT03119181] | Phase 2 | 40 participants (Actual) | Interventional | 2017-04-27 | Completed |
Intramuscular Epinephrine as an Adjunctive Treatment for Severe Pediatric Asthma Exacerbation [NCT01705964] | Phase 4 | 49 participants (Actual) | Interventional | 2013-06-30 | Completed |
A Comparison of Tumescence in Breast Reduction Surgery [NCT01602692] | Phase 4 | 40 participants (Actual) | Interventional | 2012-08-31 | Completed |
Reduction of Hip Arthroscopy Post-operative Pain Using Ultrasound-guided Fascia-iliaca Block [NCT02365961] | Phase 4 | 84 participants (Actual) | Interventional | 2015-04-30 | Completed |
Comparison of 2 Application Techniques for LET (Lidocaine 4%; Epinephrine 0.1%; Tetracaine 0.5%) Gel Used Prior to Simple Laceration Repair in Children [NCT04203225] | Phase 4 | 48 participants (Actual) | Interventional | 2017-05-22 | Completed |
A Prospective Randomized Trial of Transversus Abdominis Plane (TAP) INtraoperative Block With Bupivacaine/Dexamethasone aGainst Liposomal Bupivacaine (Exparel®): the TINGLE Trial [NCT03723447] | Phase 4 | 102 participants (Actual) | Interventional | 2018-10-23 | Completed |
Vapocoolant Spray as a Novel Local Anesthetic for Cutaneous Abscess Incision and Drainage [NCT01673061] | Phase 4 | 21 participants (Actual) | Interventional | 2012-08-31 | Terminated(stopped due to Vapocoolant not effective controlling pain compared with Lidocaine.) |
Comparing the Effectiveness of Misoprostol, Oxytocin, Carbetocin, Vasopressin, Bupivacaine and Epinephrine, Combined IV TXA Acid and Ethamsylate and Peri Cervical Tourniquet for the Reduction of Blood Loss During of Abdominal Myomectomy. [NCT05806307] | Phase 4 | 105 participants (Anticipated) | Interventional | 2023-03-15 | Recruiting |
The Effect of Buccal Infiltration Administration of Clonidine on the Success Rate of Inferior Alveolar Nerve Block on Mandibular Molars With Symptomatic Irreversible Pulpitis: a Randomized Double-blind Clinical Trial [NCT04186299] | Phase 4 | 0 participants (Actual) | Interventional | 2021-08-31 | Withdrawn(stopped due to Study activities never commenced.) |
Pre-emptive Epinephrine Nebulization Prior to Nasotracheal Intubation for Mandibular Fracture Fixation Surgeries:Dose it Really Differs? a Randomized Controlled Study [NCT05738564] | Phase 3 | 126 participants (Actual) | Interventional | 2021-09-01 | Completed |
Postoperative Analgesia After Total Knee Arthroplasty. A Comparison of Continuous Epidural Infusion and Wound Infiltration With Continuous Intraarticular Infusion [NCT00421967] | Phase 4 | 80 participants (Actual) | Interventional | 2007-01-31 | Terminated(stopped due to Interim analysis) |
A Single Center, Double-blind, Parallel-group, Two Factor Patient-Experience Management Study of ATX-101 (Deoxycholic Acid Injection) for the Reduction of Localized Subcutaneous Fat in the Submental Area [NCT02007434] | Phase 3 | 84 participants (Actual) | Interventional | 2013-12-31 | Completed |
Effect of Silver Diamine Fluoride on Local Anesthesia Efficacy in Molar Incisor Hypomineralization-affected Molars in Children: A Randomized Clinical Trial [NCT05964387] | | 50 participants (Anticipated) | Interventional | 2023-06-12 | Recruiting |
LIBERATE - LIposomal Bupivacaine vERsus Adjuncts in Total shouldErs: A Randomized Controlled Trial of Injection at the Brachial Plexus [NCT03887650] | Phase 4 | 90 participants (Actual) | Interventional | 2019-03-11 | Completed |
Loss of Resistance With Nerve Stimulation Versus Loss of Resistance Alone; Effect on Success of Thoracic Epidural Placement. [NCT03087604] | Phase 4 | 100 participants (Actual) | Interventional | 2017-03-17 | Completed |
Tranexamic Acid Versus Adrenaline for Controlling Iatrogenic Endobronchial Bleeding: a Double Blind, Randomized Controlled Trial [NCT04771923] | | 130 participants (Actual) | Interventional | 2021-02-22 | Completed |
The Role of Adrenaline in the Reduction of Subcutaneous Ecchymoses and Hematomas and in the Improvement of the Quality of Life of Patients After Classic Great Saphenous Vein Stripping [NCT04758728] | | 40 participants (Actual) | Interventional | 2015-09-10 | Completed |
Epinephrine Inhalation Aerosol USP, an HFA-MDI CLINICAL STUDY-B2 FOR ASSESSMENT OF PHARMACOKINETICS (A Randomized, Evaluator-Blind, Single-Dose, Two Arm, Crossover, PK Study in Healthy Volunteers) [NCT01188577] | Phase 1/Phase 2 | 23 participants (Actual) | Interventional | 2010-08-31 | Completed |
Infiltration Between the Popliteal Artery and the Capsule of the Knee (iPACK) With Local Infiltration of Analgesia (LIA) and Adductor Canal Block (ACB) Improves Postoperative Pain in Total Knee Arthroplasty: A Randomized Controlled Trial [NCT04635176] | Phase 4 | 120 participants (Anticipated) | Interventional | 2022-10-30 | Recruiting |
Efficacy of Ultrasound-guided Transversalis Fascia Plane Blocks for Post-cesarean Section Analgesia: a Randomized Double Blinded Control Study [NCT03236324] | Phase 2 | 106 participants (Actual) | Interventional | 2017-09-22 | Completed |
LIA in Hip Arthroscopy Patients: An Extra-Capsular Approach [NCT03070054] | Early Phase 1 | 74 participants (Actual) | Interventional | 2016-06-30 | Completed |
Arterial Pressure and Stress-Dose Steroids in In-hospital Cardiac Arrest: a Mediation Analysis of Prior Randomized Clinical Trial Data. [NCT02785224] | | 191 participants (Anticipated) | Observational | 2023-12-31 | Not yet recruiting |
Efficacy of Nebulised Hypertonic Saline (3%) Among Children With Mild to Moderately Severe Bronchiolitis - A Double Blind Randomized Controlled Trial. [NCT01276821] | Phase 4 | 100 participants (Actual) | Interventional | 2011-01-31 | Completed |
A Randomized Controlled Trial of a Full and a Fractional Ablative Carbon Dioxide Laser as Pretreatment for Photodynamic Therapy in the Management of Superficial Non Melanoma Skin Cancer [NCT03012009] | | 16 participants (Actual) | Interventional | 2014-09-30 | Completed |
A Randomized Trial of Rectal Indomethacin and Papillary Spray of Epinephrine Versus Rectal Indomethacin to Prevent Post-ERCP Pancreatitis in High Risk Patients [NCT02116309] | | 948 participants (Actual) | Interventional | 2014-08-31 | Completed |
Perioperative Pain Management for Total Shoulder Arthroplasty: A Pilot Non-Inferiority Trial [NCT05908851] | | 80 participants (Anticipated) | Interventional | 2023-11-01 | Not yet recruiting |
Optimal Timing of Intercostal Nerve Blocks During Video-Assisted Thoracic Surgeries [NCT02980835] | Phase 4 | 36 participants (Actual) | Interventional | 2016-09-28 | Completed |
Assessment of Knee Pain in Patients Receiving Continuous Femoral Nerve Block Combined With Either Ultrasound Guided Posterior Capsular Injection or Selective Tibial Nerve Block Following Total Knee Arthroplasty [NCT02701296] | | 80 participants (Actual) | Interventional | 2011-11-07 | Completed |
Bilateral Mid-Abdominal Transverse Abdominis Plane and Rectus Sheath Blocks Comparing The Use of Liposomal Bupivacaine/Bupivacaine vs. Regular Bupivacaine in Laparoscopic Colectomy Procedures. [NCT05224089] | Phase 4 | 114 participants (Anticipated) | Interventional | 2022-04-27 | Recruiting |
Postoperative Analgesia After Elective Hip Surgery - Effect of Obturator [NCT03064165] | Phase 4 | 62 participants (Actual) | Interventional | 2017-08-15 | Completed |
Effect of Papillary Epinephrine Spraying on Post-ERCP Pancreatitis in Patients Received Rectal Indomethacin: A Multi-center, Double-blind, Randomized Controlled Trial [NCT03057769] | | 3,300 participants (Actual) | Interventional | 2017-02-01 | Terminated(stopped due to This study was terminated because of an interim analysis suggesting futility of papillary epinephrine spraying in PEP prevention.) |
Pediatric Out-of-Hospital Cardiac Arrest Resuscitation: Evaluation of IM Epinephrine (The PRIME Trial) [NCT05166343] | Phase 2/Phase 3 | 76 participants (Anticipated) | Interventional | 2023-01-31 | Not yet recruiting |
Prospective Evaluation of Topical Anesthesia in Children [NCT04378283] | | 99 participants (Actual) | Interventional | 2016-05-31 | Completed |
Second-look Endoscopy in High Risk Patients After Endoscopic Hemostasis to Their Bleeding Peptic Ulcers Improves Their Outcomes [NCT02352155] | | 157 participants (Actual) | Interventional | 2015-02-04 | Terminated |
Optimal Method for Mydriasis in Cataract Surgery [NCT02909140] | | 3 participants (Actual) | Interventional | 2016-09-30 | Terminated(stopped due to insufficient patient recruitment) |
Comparison of Adductor Canal Block Combined With IPACK Block and Adductor Canal Block Combined With PCI for Postoperative Analgesia and Function Recovery Following Total Knee Arthroplasty:A Prospective, Double-Blind, Randomized Controlled Study [NCT05943080] | | 159 participants (Anticipated) | Interventional | 2023-06-01 | Active, not recruiting |
A Randomized Double-Blinded, Placebo-Controlled Study of Omalizumab for Idiopathic Anaphylaxis [NCT00890162] | Phase 2 | 16 participants (Actual) | Interventional | 2009-04-27 | Completed |
Metabolic Adaptation to High-frequent Hypoglycaemia in Type 1 Diabetes - the HypoADAPT Study [NCT05095259] | | 60 participants (Anticipated) | Interventional | 2019-12-16 | Active, not recruiting |
A Clinical Comparison of Microsurgical Versus Conventional Surgical Approaches for the Semilunar Coronally Advanced Flap [NCT02433899] | Phase 4 | 14 participants (Actual) | Interventional | 2010-10-31 | Completed |
Comparison of Plasma Concentrations of Levobupivacaine With and Without Epinephrine for Transversus Abdominis Plane Block Under Ultrasound. [NCT01596998] | Phase 4 | 11 participants (Actual) | Interventional | 2011-12-31 | Completed |
Efficacy of Alkalinised 2% Mepivacaine for Local Infiltration Anesthesia, in Ambulatory Phlebectomy [NCT01611324] | Phase 4 | 100 participants (Actual) | Interventional | 2012-05-31 | Completed |
Assessment and Hemodynamic Response in CABG After Cardiopulmonary Bypass Using Intraoperative Transesophegeal Echocardiography [NCT01616069] | Phase 4 | 81 participants (Actual) | Interventional | 2012-02-29 | Completed |
Effect of Target Intraoperative Blood Pressure on the Incidence of Post-operative Cognitive Dysfunction in Patients Aged 75 and Older Undergoing General Anesthesia for Non-cardiac Surgery: an International Multicenter Randomized Controlled Trial [NCT02428062] | Phase 2/Phase 3 | 1,812 participants (Anticipated) | Interventional | 2014-10-31 | Suspended(stopped due to Pending Pilot study results evaluation) |
Bupivacaine Liposome Suspension Versus a Concentrated Multi Drug Periarticular Injection in 70 Patients Undergoing Total Knee Arthroplasty Without Femoral Nerve Block: a Double-blinded, Randomized Clinical Trial [NCT02299349] | | 70 participants (Actual) | Interventional | 2013-08-31 | Completed |
Cardiac Index Changes With Ephedrine, Phenylephrine, Ondansetron and Norepinephrine During Spinal Anesthesia for Cesarian Section [NCT03421860] | Phase 4 | 120 participants (Actual) | Interventional | 2017-02-23 | Completed |
Impact of Intracoronary Versus Central and Peripheral Intravenous Epinephrine Administration During Cardiac Arrest in The Cardiac Catheterization Laboratory for Acute Myocardial Infarction Patients. [NCT05253937] | | 160 participants (Actual) | Observational | 2018-04-01 | Completed |
A Prospective, Randomized, Single-Blind Study to Evaluate the Efficacy of Transversus Abdominis Plane Versus Paravertebral Regional Blockade in Patients Undergoing Laparoscopic Colectomy [NCT02164929] | | 17 participants (Actual) | Interventional | 2013-12-31 | Terminated(stopped due to Poor recruitment) |
The Effects of Injection Site Cooling and Solution Buffering on Perceived Pain During Local Anesthesia Administration [NCT04991597] | | 0 participants (Actual) | Interventional | 2022-01-01 | Withdrawn(stopped due to Shift in research focus) |
Efficacy of Injected Local Anesthetic vs Topical Anesthetic in Cosmetic Injectable Fillers [NCT02379221] | | 49 participants (Actual) | Interventional | 2014-09-30 | Completed |
Fertility and Pregnancy in Patients With Classic Congenital Adrenal Hyperplasia [NCT06153043] | | 55 participants (Anticipated) | Observational | 2023-12-31 | Not yet recruiting |
Optimal Vasopressor Titration Pilot Randomized Controlled Trial [NCT01800877] | | 120 participants (Actual) | Interventional | 2013-04-30 | Completed |
Comparing Pre-emptive Injection of Peri-Articular-Multimodal Drug With Oral Celecoxib for Postoperative Pain Management in Total Knee Arthroplasty: A Randomized Clinical Trial [NCT05324995] | Phase 2 | 146 participants (Actual) | Interventional | 2021-01-01 | Completed |
Anesthetic Efficacy of 4% Buffered Lidocaine in Emergency Patients With Facial Swelling. [NCT01981772] | | 88 participants (Actual) | Interventional | 2013-03-31 | Completed |
Comparision Between Hemodynamic Response of Dexmedetomidine and Remifentanil for Epinephrine Local Injection in Patient With Endoscopic Sinus Surgery Under General Anesthesia [NCT02464722] | Phase 4 | 50 participants (Anticipated) | Interventional | 2015-08-31 | Enrolling by invitation |
Epinephrine Sprayed on the Papilla and Rectal Indomethacin Versus Sterile Water Sprayed on the Papilla and Rectal Indomethacin for Preventing Pancreatitis After Endoscopic Retrograde Cholangiopancreatography: A Prospective, Randomized, Controlled Trial [NCT02959112] | | 548 participants (Actual) | Interventional | 2016-05-31 | Terminated(stopped due to Because previous studies had found no difference, and one recent study even reported a higher incidence of PEP in treatment arm) |
Transversus Abdominis Plane (TAP) Infiltration vs. Surgical Infiltration of Local Anesthetic in Laparoscopic and Robotic Assisted Hysterectomy [NCT02519023] | Phase 4 | 87 participants (Actual) | Interventional | 2016-07-31 | Completed |
A Comparison of Ultrasound Guided Transversus Abdominis Plane Nerve Block Technique Versus Laparoscopic Transversus Abdominis Plane Nerve Block Technique Versus No Block on Postoperative Opioid Consumption After Major Colorectal Surgery [NCT02538679] | | 127 participants (Actual) | Interventional | 2015-08-07 | Completed |
Liposomal Bupivacaine in Implant Based Breast Reconstruction [NCT02659501] | | 24 participants (Actual) | Interventional | 2015-07-31 | Terminated |
Post-surgical Pain Care Pathways During Enhanced Recovery Surgery Using Exparel (Bupivacaine Liposome Injectable Suspension) Plus Bupivacaine With Epinephrine Versus Bupivacaine. [NCT03001453] | Phase 2 | 107 participants (Actual) | Interventional | 2014-04-30 | Completed |
Comparing Blood Loss and Visualization After the Preoperative Use of Topical 0.05% Oxymetazoline Versus 1:1000 Epinephrine Prior to Endoscopic Sinus Surgery [NCT03228914] | Phase 4 | 20 participants (Actual) | Interventional | 2018-06-14 | Completed |
Efficacy of Subcutaneous Infiltration With Local Anesthetic During Elective Cesarean Delivery for Postoperative Pain Control: a Randomized Controlled Trial [NCT03383588] | Phase 2 | 26 participants (Actual) | Interventional | 2018-07-19 | Terminated(stopped due to study was published during initial recruitment that showed no difference) |
Comparison of the Effect of Epinephrine, Norepinephrine and Phenylephrine on Spinal Anesthesia Induced Hypotension [NCT03163914] | Phase 4 | 160 participants (Actual) | Interventional | 2017-07-19 | Completed |
Postoperative Prolonged Vasoactive-inotropic Support and Levosimendan Use After Lung Transplantation: a Retrospective Analysis of Risk Factors and Impact on Outcomes [NCT05702333] | | 150 participants (Actual) | Observational | 2017-02-01 | Completed |
An Open-label, Cohort Study on Effects and Long-term Prognosis of Adrenal Artery Ablation and Spironolactone in Patients With Primary Aldosteronism [NCT04409431] | | 60 participants (Anticipated) | Interventional | 2019-12-01 | Recruiting |
A Phase 2 Multicenter, Randomized, Double-blind, Parallel-group, Active-control, Dose-ranging Study to Evaluate the Safety and Efficacy of a Single Administration of SKY0402 for Prolonged Postoperative Analgesia in Subjects Undergoing Primary Unilateral I [NCT00485433] | Phase 2 | 98 participants (Actual) | Interventional | 2007-06-30 | Completed |
Inhaled Beta-2 Agonist Versus Epinephrine For Treatment of Transient Tachypnea of Newborn [NCT05006235] | Phase 1 | 135 participants (Actual) | Interventional | 2014-02-01 | Completed |
The Effect of Popliteal Plexus Block on Postoperative Pain After Total Knee Arthroplasty [NCT03198403] | Phase 4 | 17 participants (Actual) | Interventional | 2017-08-01 | Completed |
Efficacy of External Nasal Nerve Block on Postoperative Agitation Following Nasal Surgeries Under General Anesthesia. Randomized, Controlled Trial [NCT03069027] | | 100 participants (Actual) | Interventional | 2016-08-15 | Completed |
To Compare the Pulpal Oxygen Saturation Level After Administering Mepivacaine With and Without Vasoconstrictor: A Randomized Clinical Trial [NCT04947267] | Phase 2 | 60 participants (Actual) | Interventional | 2018-05-30 | Completed |
Addition of Clonidine to Ropivacaine in Adductor Canal Block for Postoperative Pain Relief in Total Knee Arthroplasty: A Prospective Randomized Double Blind Placebo Controlled Trial [NCT03057015] | Phase 4 | 80 participants (Anticipated) | Interventional | 2017-05-22 | Recruiting |
The Pectoral Block for Breast Augmentation Surgery: a Volunteers' and Patients' Study. [NCT03040167] | Phase 4 | 20 participants (Actual) | Interventional | 2017-10-01 | Completed |
Early Ultrasound-guided Nerve Block for Painful Hand Injuries in the Emergency Department [NCT03195413] | | 15 participants (Actual) | Interventional | 2017-07-01 | Completed |
Ultrasound-guided Median Nerve Block With Dextrose 5% Hydrodissection: Determination of the Minimal Effective Volume of Local Anesthetic [NCT02438657] | Phase 2/Phase 3 | 52 participants (Actual) | Interventional | 2015-05-21 | Completed |
Comparative Evaluation of the Anesthetic Efficacy of 1,8mL and 3,6mL of 4% Articaine With 1: 100,000 Epinephrine in Blocking the Inferior Alveolar Nerve in Patients With Irreversible Pulpitis of Mandibular Molars [NCT02422823] | | 90 participants (Actual) | Interventional | 2015-04-30 | Completed |
Two-arm, Double-blind Randomized Study Comparing Exparel and Exparel Plus an Adductor Canal Block in Total Knee Arthroplasty [NCT02365727] | Phase 4 | 0 participants (Actual) | Interventional | 2015-04-30 | Withdrawn(stopped due to Protocol not feasible as written) |
Adductor Canal Block and Functional Recovery After Total Knee Arthroplasty. A Double-Blind, Randomized Controlled Trial [NCT02411149] | Phase 4 | 200 participants (Actual) | Interventional | 2014-04-30 | Completed |
Psoas Compartment Block Versus Periarticular Local Anesthetic Infiltration for Pain Management for Total Hip Arthroplasty: A Prospective, Randomized Study [NCT02658149] | Phase 4 | 100 participants (Actual) | Interventional | 2016-05-31 | Completed |
Title of Project: Liposomal Bupivacaine (Exparel) Versus Bupivacaine And Dexamethasone Intercostal Nerve Blocks For Robotic Thoracic Surgery: A Prospective Randomized Single-Blinded Clinical Trial [NCT03906617] | Phase 4 | 34 participants (Anticipated) | Interventional | 2019-04-10 | Recruiting |
Comparison of Two Different Concentrations of Local Anesthetic in Patient Reported Pain in Oculoplastic Surgery [NCT06121141] | Phase 4 | 30 participants (Anticipated) | Interventional | 2023-08-07 | Enrolling by invitation |
Clinical Effectiveness of Erector Spinae Plane Block in Peri-operative Analgesia for Laparoscopic Kidney Procedures [NCT03874091] | | 62 participants (Actual) | Interventional | 2019-01-15 | Completed |
A Phase 2, Two-Part, Multicenter Study of HTX-011 in Spinal Surgery [NCT04911062] | Phase 2 | 32 participants (Actual) | Interventional | 2022-04-07 | Completed |
Comparison of Interscalene vs. Superficial Cervical Block vs. Combination of Both Blocks for Analgesia After Operative Repair of Midshaft and Lateral Clavicle Fractures [NCT03094481] | | 120 participants (Anticipated) | Interventional | 2016-10-21 | Recruiting |
Effect of Topical and Systemic Tranexemic Acid on Bleeding and Quality of Surgical Field During Ear Exploration Surgery. A Double Blind Randomized Clinical Trial [NCT03112135] | Phase 2 | 90 participants (Anticipated) | Interventional | 2017-04-30 | Recruiting |
Role of Adrenaline in the Inflammatory Response in People With Diabetes Mellitus Type 1, and Healthy Individuals [NCT05990933] | | 30 participants (Anticipated) | Interventional | 2023-09-30 | Not yet recruiting |
Effects of Nasal Desmopressin Spray Versus Topical Epinephrine on Surgical Field Clarity and Hemodynamics in Endonasal Dacryocystorhinostomy: A Randomized Clinical Study. [NCT05507476] | | 52 participants (Actual) | Interventional | 2022-09-01 | Completed |
Local Injection of Tranexamic Acid May Reduce Bleeding, Injection Pain, and Other Post-op Complications During Mohs Micrographic Surgery [NCT04630886] | Early Phase 1 | 200 participants (Anticipated) | Interventional | 2021-06-16 | Enrolling by invitation |
Adjuvants to Ultrasonic Guided Interscalene Block In Arthroscopic Rotator Cuff Repair; Morphine and/or Nalbuphine [NCT03034382] | Phase 2 | 80 participants (Anticipated) | Interventional | 2016-01-31 | Recruiting |
CanROC Epinephrine Dose: Optimal Versus Standard Evaluation Trial (CanROC EpiDOSE Trial) [NCT03826524] | Phase 4 | 3,790 participants (Anticipated) | Interventional | 2023-05-24 | Recruiting |
Evaluation of Cardiac Arrhythmias in Hand Surgery Using Local Anesthesia With Adrenaline [NCT04029610] | | 110 participants (Actual) | Interventional | 2018-08-14 | Completed |
Gonyautoxins Local Periarticular Injection for Pain Management After Total Knee Arthroplasty: A Double Blind Randomized Study [NCT03025594] | Phase 3 | 64 participants (Anticipated) | Interventional | 2017-01-31 | Recruiting |
Nebulized Epinephrine Versus Nebulized Salbutamol in Bronchiolitis Among Children Aged 1month-24months [NCT03814954] | | 90 participants (Actual) | Interventional | 2019-01-01 | Completed |
Ultrasound-guided Peripheral Nerve Block for Non-intubated Uniportal Video-assisted Thoracoscopic Surgery [NCT03083080] | | 30 participants (Anticipated) | Interventional | 2017-03-27 | Not yet recruiting |
Pharmacokinetics of Intramuscular Adrenaline in Food--Allergic Teenagers: Does Dose Matter? [NCT03366298] | Phase 4 | 12 participants (Actual) | Interventional | 2017-11-24 | Completed |
Characterizing and Comparing the Duration of Local Anesthetic in Dermatologic Surgery [NCT05767749] | Phase 4 | 75 participants (Actual) | Interventional | 2023-03-14 | Completed |
Does the Addition of Epinephrine Increase the Duration of Intrathecal Hyperbaric Bupivacaine for Repeat Cesarean Section? [NCT02369510] | Phase 4 | 68 participants (Actual) | Interventional | 2015-02-28 | Completed |
Comparison of Rectal Infiltration of Exparel vs. 0.25% Bupivacaine With Epinephrine vs. Placebo for Analgesic Benefit Following Hemorrhoidectomy [NCT02104414] | Phase 4 | 11 participants (Actual) | Interventional | 2014-04-30 | Terminated(stopped due to low enrollment) |
Preemptive Local Anesthesia in Vaginal Surgery, A Prospective, Randomised Trial [NCT00318292] | Phase 4 | 90 participants (Actual) | Interventional | 2006-04-30 | Completed |
Phase 3 Study of Ropivacaine (With Epinephrine) in BABA Endoscopic and Robotic Thyroidectomy [NCT02112370] | Phase 3 | 148 participants (Actual) | Interventional | 2014-05-31 | Completed |
A Phase 2 Multicenter, Randomized, Double-blind, Parallel-group, Active-control, Dose-ranging Study to Evaluate the Safety and Efficacy of a Single Administration of SKY0402 for Prolonged Postoperative Analgesia in Subject Undergoing Hemorrhoidectomy [NCT00529126] | Phase 2 | 100 participants (Actual) | Interventional | 2007-09-30 | Completed |
Methemoglobin Levels in Generally Anesthetized Pediatric Dental Patients Receiving Prilocaine Versus Lidocaine [NCT01402869] | | 91 participants (Actual) | Interventional | 2011-08-31 | Completed |
Subcutaneous Tranexamic Acid in Nasal Mohs Local Flap Reconstruction: Perioperative Bleeding, Edema, and Ecchymosis [NCT06057675] | Phase 2 | 100 participants (Anticipated) | Interventional | 2023-12-31 | Not yet recruiting |
The Effectiveness of Automated Soft Tissue Vibration in Reducing Pain and Accelerating Action of Intraoral Local Anesthesia Injections in Adult Dental Patients. A Randomized Crossover Clinical Trial. [NCT03839134] | | 166 participants (Actual) | Interventional | 2019-03-20 | Completed |
Effects of Pre-emptive Scalp Infiltration With Low-dose Ketorolac and Ropivacaine for Postoperative Pain Relief After Elective Supratentorial Craniotomy (PAINLESS): a Randomized Controlled Pilot Trial [NCT04380298] | Phase 4 | 40 participants (Anticipated) | Interventional | 2020-12-01 | Not yet recruiting |
A One-year Placebo-Controlled Study Evaluating the Efficacy and Safety of the House Dust Mite Sublingual Allergen Immunotherapy Tablet (SCH 900237/MK 8237) in Children and Adult Subjects With House Dust Mite-Induced Allergic Rhinitis/Rhinoconjunctivitis W [NCT01700192] | Phase 3 | 1,482 participants (Actual) | Interventional | 2013-01-31 | Completed |
Administration of Local Anesthetic in Trigger Thumb Surgery: A Randomized Clinical Trial [NCT03873480] | | 31 participants (Actual) | Interventional | 2018-10-02 | Completed |
The Role of Hypertonic Dextrose Spray as Endoscopic Topical Hemostatic Agent for Acute Non-Variceal Upper Gastrointestinal Bleeding: A Randomized Controlled Trial [NCT04979273] | | 66 participants (Anticipated) | Interventional | 2021-03-01 | Recruiting |
Fast-track Rehabilitation Protocol for Total Knee Arthroplasty: A Randomized Controlled Trial Comparing Local Infiltration Analgesia With Femoral Nerve Block [NCT01966263] | Phase 4 | 80 participants (Actual) | Interventional | 2013-11-30 | Completed |
Analgesia After Total Knee Arthroplasty: Adductor Canal Block With Periarticular Injection and IPACK (ACB/PAI/IPACK) Versus Periarticular Injection (PAI). A Double-Blinded Randomized Controlled Trial [NCT03094663] | | 86 participants (Anticipated) | Interventional | 2017-02-28 | Recruiting |
Alkalinization of Adrenalized Lidocaine in Extending Epidural Analgesia for Extremely Urgent Cesarean Section During Labor: a Randomized Controlled Trial. [NCT05313256] | Phase 2/Phase 3 | 66 participants (Anticipated) | Interventional | 2022-07-14 | Recruiting |
The Use of Epinephrine Infusion for Prophylaxis Against Maternal Hypotension During Cesarean Delivery: a Randomized Controlled Dose-finding Trial [NCT05279703] | Phase 4 | 276 participants (Anticipated) | Interventional | 2022-03-21 | Recruiting |
Voiding Function After Mid-Urethral Slings With and Without Local Anesthetic: Randomized Controlled Trial [NCT01583166] | | 90 participants (Actual) | Interventional | 2012-03-31 | Completed |
Comparison of Different Approaches for Supraclavicular Block and Their Effects on Diaphragm Muscle Function Evaluated With Diaphragm Thickening Fraction [NCT04756050] | Phase 4 | 90 participants (Actual) | Interventional | 2021-02-16 | Completed |
Efficacy of a Peri-Operative Surgical-Site, Multimodal Drug Injection in Pediatric Patients With Cerebral Palsy Undergoing Hip Surgery: A Randomized Controlled Trial [NCT04074265] | Phase 4 | 34 participants (Actual) | Interventional | 2019-12-01 | Completed |
Treatment of Ventricular Tachyarrhythmias Refractory To Shock With Beta Blockers: The SHOCK and BLOCK Trial [NCT00401882] | Phase 2 | 7 participants (Actual) | Interventional | 2007-01-31 | Terminated(stopped due to Difficult accrual) |
TAP-catheter With Intermittent Bolus Injections of Bupivacain, an Alternative to Epidural Catheter Infusion After Colon Surgery? [NCT01395043] | | 15 participants (Actual) | Interventional | 2010-09-30 | Completed |
Phase 3, Multicenter, Randomized, Double-Blind, Parallel-group, Active-control Study to Evaluate the Safety and Efficacy of a Single Administration of SKY0402 for Prolonged Postoperative Analgesia in Subjects Undergoing Hemorrhoidectomy [NCT00744848] | Phase 3 | 204 participants (Actual) | Interventional | 2008-08-31 | Completed |
Risk Factors and Postoperative Complications of Reperfusion Syndrome and Vasoplegic Syndrome in Patients With Vasoactive Support During Liver Transplant Surgery [NCT05658120] | | 246 participants (Actual) | Observational | 2022-12-13 | Completed |
Multicenter, Randomized, Split-mouth Study to Evaluate the Acceptance and Preference of Lidocaine Gel Compared to Injection Anesthesia After Non Surgical Periodontal Treatment [NCT03354312] | Phase 4 | 94 participants (Actual) | Interventional | 2017-12-05 | Completed |
Comparison of Pain of Conventional to Buffered Local Anesthesia During Injection in Pediatric Dental Patients. A Prospective, Double-blind, Randomized, Crossover Study [NCT01622296] | Phase 4 | 20 participants (Actual) | Interventional | 2012-04-30 | Completed |
A Prospective Randomized, Double-blind Study of the Anesthetic Efficacy of Buffered Articaine as a Primary Buccal Infiltration of the Mandibular First Molar. [NCT01862614] | Phase 4 | 80 participants (Actual) | Interventional | 2013-04-30 | Completed |
Epinephrine in the Pediatric Intensive Care Unit: A Dose-Effect Trial (EPI Dose) [NCT05327556] | Phase 2 | 86 participants (Anticipated) | Interventional | 2023-02-08 | Enrolling by invitation |
The Effect of Final Irrigation Using Antimicrobial-corticosteroid Mixture Versus Cryotherapy on Post-instrumentation Pain and Microbial Reduction in Patients Having Single Canal - Teeth With Necrotic Pulps: A Randomized Clinical Trial [NCT05739682] | Phase 3 | 28 participants (Anticipated) | Interventional | 2023-06-01 | Not yet recruiting |
Efficacy of Buprenorphine on Postoperative Endodontic Analgesia [NCT03268278] | Phase 1 | 10 participants (Actual) | Interventional | 2017-04-01 | Terminated(stopped due to Loss of interest) |
The Efficiency of Periarticular Multimodal Drug Injection in Pain Management Following Primary Unilateral Total Knee Arthroplasty: a Randomized Controlled Trial [NCT06112548] | | 80 participants (Anticipated) | Interventional | 2023-11-01 | Not yet recruiting |
Bipolar Hemostatic Forceps Versus Standard Therapy by Hemoclip and or Epinephrin Injection as Initial Endoscopic Treatment in Acute Non-variceal Upper GI Bleeding: a Prospective, Randomized Multicenter Study [NCT05353062] | | 80 participants (Anticipated) | Interventional | 2023-01-01 | Recruiting |
Evaluation of New Methods for Prediction of Fetal Lung Maturity in Diabetic Mothers [NCT03159234] | | 54 participants (Actual) | Interventional | 2016-04-30 | Completed |
CLINICAL STUDY-B3 FOR ASSESSMENT OF PHARMACOKINETICS, A Randomized, Evaluator-Blind, Single-Dose, Three Arm, Crossover,PK Study in Healthy Volunteers [NCT01255709] | Phase 2 | 24 participants (Actual) | Interventional | 2010-12-31 | Completed |
Comparison Between Epinephrine Versus Tranexamic Acid Usage During Upper Gastrointestinal Tract Endoscopic Resection Procedures for the Reduction of Intraprocedural and Postprocedural Bleeding [NCT05688020] | Phase 4 | 200 participants (Anticipated) | Interventional | 2023-02-01 | Recruiting |
Articaine Success in Pulpectomy of Primary Molars With Irreversible Pulpitis in Children Under Four Years: a Randomized Controlled Trial [NCT05944341] | | 164 participants (Anticipated) | Interventional | 2023-06-01 | Recruiting |
A Phase III, Randomized, Placebo-Controlled Clinical Trial to Study the Efficacy and Safety of MK-3641, a Ragweed (Ambrosia Artemisiifolia) Sublingual Immunotherapy Tablet, in Children With a History of Ragweed-Induced Rhinoconjunctivitis With or Without [NCT02478398] | Phase 3 | 1,025 participants (Actual) | Interventional | 2015-07-20 | Completed |
Hypoglycemia Associated Autonomic Dysfunction Dose Response of Epinephrine [NCT02692313] | Early Phase 1 | 32 participants (Anticipated) | Interventional | 2016-06-30 | Recruiting |
Articaine 4% Efficacy and Safety in Extraction and Pulpotomy of Primary Molars of Children Below the Age of Four Years. [NCT05101785] | | 292 participants (Anticipated) | Interventional | 2021-11-01 | Not yet recruiting |
Lidocaine With Epinephrine vs. Bupivacaine With Epinephrine as Local Anesthetic Agents in Wide-awake Hand Surgery: an Outcome Study of Patients' Pain Perception. [NCT02315573] | | 61 participants (Actual) | Interventional | 2014-10-31 | Completed |
Complication in Laparoscopic Renal and Adrenal Surgery (CLARAS): an International Multicenter Study [NCT05322265] | | 350 participants (Anticipated) | Observational | 2017-04-01 | Recruiting |
The Effect of the Popliteal Plexus Block on Postoperative Pain After Total Knee Arthroplasty - a Randomized, Controlled, Double-blinded Study [NCT03439787] | Phase 4 | 15 participants (Actual) | Interventional | 2018-05-15 | Terminated(stopped due to Methodological problems/problems in the study design (competing pain and a placebo effect). No serious adverse events or other safety issues) |
An Open-label, Prospective, Controlled Clinical Trial on Effects and Safety of Adrenal Artery Ablation (Triple A) for Primary Aldosteronism [NCT03398785] | Phase 3 | 66 participants (Actual) | Interventional | 2017-10-01 | Completed |
Nor-epinephrine Versus Midodrine/Octreotide in Patients With Hepatorenal Acute Kidney Injury [NCT04522297] | | 91 participants (Actual) | Interventional | 2018-04-15 | Completed |
Minimum Effective Local Anaesthetic Volume of a 1:1 Mixture of 2% Lidocaine With 5ug/ml of Epinephrine and 0.5% Levobupivacaine Required for Ultrasound Guided Selective Trunk Block: A Dose Finding Study [NCT04773405] | | 25 participants (Actual) | Interventional | 2021-03-10 | Completed |
Intravenous Epinephrine Bolus for Prevention of Postintubation Collapse in Intensive Care Septic Patients Predicted by Shock Index. [NCT06115473] | | 44 participants (Anticipated) | Interventional | 2023-08-01 | Recruiting |
Impact of Adding iPACK Block With Dexamethasone to Existing APS Multimodal Analgesia Protocol for Patients Undergoing Total Knee Arthroplasty [NCT04917055] | Phase 4 | 14 participants (Actual) | Interventional | 2021-06-07 | Terminated(stopped due to staffing) |
An Investigator-Initiated, Double-Blind, Patient-Controlled, Randomized Control Trial Comparing the Effectiveness of Liposomal Bupivacaine to a Solution of Bupivacaine, Epinephrine Clonidine and Dexamethasone in Bilateral, Single Shot, Erector Spinae Plan [NCT04603911] | Phase 2 | 75 participants (Actual) | Interventional | 2020-12-04 | Active, not recruiting |
Analgesic Effect of Adding Popliteal Plexus Block to Standard Saphenous Nerve Block in Patients Scheduled for Elective Arthroscopic Anterior Cruciate Ligament Reconstruction : Randomized Observer Blind Clinical Trial [NCT04020133] | | 58 participants (Anticipated) | Interventional | 2019-09-05 | Recruiting |
Levosimendan Versus Adrenaline in Patients With Low Left Ventricular Function Undergoing Elective On-Pump Coronary Artery Bypass Graft Surgery. A Randomized Controlled Study [NCT05222256] | | 52 participants (Anticipated) | Interventional | 2022-03-31 | Not yet recruiting |
Do Intraoperative Periarticular Injections Improve Postoperative Pain Control in Patients Receiving Duramorph (Preservative Free) During Total Knee Arthroplasty? A Prospective, Double-Blind, Randomized Controlled Trial [NCT02570503] | Phase 4 | 64 participants (Actual) | Interventional | 2015-10-31 | Terminated(stopped due to Study's primary aims are no longer clinically impactful, as intrathecal morphine has fallen out of favor and replaced with different agents so that outpatient/23 hr surgery is more predictably achievable.) |
Efficacy of Peri-Incisional Multimodal Drug Injection in Reducing Post-Operative Pain Following Lumbar Spine Surgery [NCT03513445] | Phase 3 | 0 participants (Actual) | Interventional | 2018-06-01 | Withdrawn(stopped due to No participants enrolled) |
Comparison of the Effect of Vasopressin, Steroid, and Epinephrine Treatment in Patients With Out-of-hospital Cardiac Arrest: Multi-center, Double Blind, Randomized, Placebo-controlled Study [NCT03317197] | Phase 4 | 834 participants (Anticipated) | Interventional | 2018-01-01 | Recruiting |
A Randomized Clinical Trial to Compare the Addition of Epinephrine (no Epinephrine, 100mcg, and 200mcg) to the Standard Dose of Hyperbaric Bupivacaine 12mg, Fentanyl 20mcg and Morphine 150mcg in Scheduled C-sections. [NCT03335293] | Phase 4 | 0 participants (Actual) | Interventional | 2019-10-31 | Withdrawn(stopped due to Due to FDA constraints on the off label use of the medications we will not be able to conduct this evaluation.) |
The Impact of Retropubic Lidocaine vs Saline on Postoperative Urinary Retention Following Midurethral Sling: A Randomized Placebo Controlled Trial [NCT03913845] | Phase 4 | 150 participants (Anticipated) | Interventional | 2019-11-25 | Recruiting |
Adrenal Artery Ablation Treats Primary Aldosteronism With Resistant Hypertension (AAA-RHT) [NCT04345198] | | 36 participants (Actual) | Interventional | 2017-10-01 | Completed |
Impact of intRacoronary adrEnaline on Myocardial reperfuSion in STEMI paTients With Persistent Impaired cORonary Flow After pErcutaneous Coronary Intervention: the RESTORE-SIRIO Randomized Controlled Trial [NCT02405130] | | 0 participants (Actual) | Interventional | 2015-04-30 | Withdrawn |
A Prospective, Randomized Clinical Trial of Two Periarticular Multimodal Drug Injections in Total Hip and Knee Arthroplasty [NCT02543801] | Phase 4 | 239 participants (Actual) | Interventional | 2016-01-25 | Completed |
Prospective, Randomized Controlled Trial Comparing Continuous Posterior Lumbar Plexus Nerve Block vs Periarticular Injection With Ropivacaine or Liposomal Bupivacaine (Exparel®) on Patients Undergoing Total Hip Arthroplasty [NCT02242201] | Phase 4 | 165 participants (Actual) | Interventional | 2014-09-30 | Completed |
[information is prepared from clinicaltrials.gov, extracted Sep-2024] |
Trial | Outcome |
NCT00318292 (1) [back to overview] | Visual Analogue Scale (VAS) Pain Score |
NCT00358579 (5) [back to overview] | Return of Spontaneous Circulation. |
NCT00358579 (5) [back to overview] | Neurological Status on Discharge or at 30 Days Post Arrest, if Not Discharged. |
NCT00358579 (5) [back to overview] | Neurological Status at 1 Year. |
NCT00358579 (5) [back to overview] | Survival to Hospital Discharge. |
NCT00358579 (5) [back to overview] | Survival to Admission. |
NCT00401882 (3) [back to overview] | Adverse Effects |
NCT00401882 (3) [back to overview] | Return of Spontaneous Circulation |
NCT00401882 (3) [back to overview] | Survival to Hospital Discharge |
NCT00435994 (2) [back to overview] | Lung Function |
NCT00435994 (2) [back to overview] | Endothelial Growth Factor (VEGF) |
NCT00485433 (1) [back to overview] | Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) With Activity (NRS-A) Pain Intensity Scores From 0 Through 72 Hours |
NCT00485693 (1) [back to overview] | Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) With Activity (NRS-A) Pain Intensity Scores Through Postoperative Day 4 |
NCT00492973 (5) [back to overview] | Length of Hospital Stay |
NCT00492973 (5) [back to overview] | Knee Society Scores |
NCT00492973 (5) [back to overview] | Knee Range of Motion |
NCT00492973 (5) [back to overview] | Complications, Such as Infections, Hospital Readmissions, Manipulations Under Anesthesia, Etc. |
NCT00492973 (5) [back to overview] | Amount of Pain Medication Taken Per Day |
NCT00529126 (1) [back to overview] | Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) at Rest (NRS-R) Pain Intensity Scores From 0 Through 72 Hours |
NCT00562627 (3) [back to overview] | Time to Readiness for Discharge |
NCT00562627 (3) [back to overview] | Pain at Rest (VAS) |
NCT00562627 (3) [back to overview] | Opioid Use |
NCT00744848 (1) [back to overview] | Area Under the Curve (AUC) of the Numeric Rating Scale at Rest (NRS-R) Pain Intensity Scores |
NCT00813111 (1) [back to overview] | Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) With Activity (NRS-A) Pain Intensity Scores |
NCT00890162 (1) [back to overview] | Reduction in the Number and Timing of Anaphylactic Events in Subjects With a History of Frequent Idiopathic Anaphylaxis. |
NCT00895843 (1) [back to overview] | Number of Patients Needing Rescue Medication |
NCT00901628 (6) [back to overview] | Pain( Visual Analog Scale ) |
NCT00901628 (6) [back to overview] | Maximal Flexion Angle Degree on Postoperative 7 Day |
NCT00901628 (6) [back to overview] | Intravenous Patient Controlled Analgesia(PCA) Consumption During 24 Hours After Surgery |
NCT00901628 (6) [back to overview] | the Proportion of Patients Who Were Satisfied With the Pain Management |
NCT00901628 (6) [back to overview] | The Proportion of Patients Who Could Raise Leg With Replaced Knee Extended |
NCT00901628 (6) [back to overview] | Participant Number of Postoperative Nausea and Vomiting During 24 Hours After Surgery |
NCT01042093 (3) [back to overview] | Narcotic Consumption During Hospitalization |
NCT01042093 (3) [back to overview] | Numerical Rating Scale (NRS) Pain Scores During Hospitalization. |
NCT01042093 (3) [back to overview] | Knee Society Pain Scores at 6 Week Follow-up Appointment |
NCT01080625 (1) [back to overview] | Occurrence of Postreperfusion Syndrome (PRS) |
NCT01143051 (16) [back to overview] | Vital Signs: Systolic Blood Pressure (SBP) |
NCT01143051 (16) [back to overview] | Vital Signs: Heart Rate (HR) |
NCT01143051 (16) [back to overview] | Concentration vs. Time for Total Epinephrine From Time Zero to 6 Hours Post-dose |
NCT01143051 (16) [back to overview] | Time to Reach Peak Concentration (Tmax) for Total Epinephrine |
NCT01143051 (16) [back to overview] | Peak Concentration (Cmax) for Total Epinephrine From Time Zero to 6 Hours Post-dose |
NCT01143051 (16) [back to overview] | Number of Subjects With Significant Changes in Physical Examination |
NCT01143051 (16) [back to overview] | Serum Potassium Levels |
NCT01143051 (16) [back to overview] | Vital Signs: Diastolic Blood Pressure (DBP) |
NCT01143051 (16) [back to overview] | Hand Tremor Scores |
NCT01143051 (16) [back to overview] | Serum Glucose Levels |
NCT01143051 (16) [back to overview] | Area Under the Curve From Time Zero to 6 Hours Post-dose (AUC[0-6]) |
NCT01143051 (16) [back to overview] | Baseline Concentration (C0) of Labeled Epinephrine Total Epinephrine |
NCT01143051 (16) [back to overview] | Half-life (t1/2) for Total Epinephrine |
NCT01143051 (16) [back to overview] | ECG: QT Interval |
NCT01143051 (16) [back to overview] | ECG: QTc Interval |
NCT01143051 (16) [back to overview] | Number of Subjects With Significant Changes in Laboratory Tests |
NCT01188577 (6) [back to overview] | Baseline Concentration (C0) of Total Epinephrine |
NCT01188577 (6) [back to overview] | Half-life (t1/2) of Total Epinephrine |
NCT01188577 (6) [back to overview] | Peak Concentration (Cmax) of Total Epinephrine From Time Zero to 6 Hours Post-dose |
NCT01188577 (6) [back to overview] | Time to Reach Peak Concentration (Tmax) for Total Epinephrine |
NCT01188577 (6) [back to overview] | Area Under the Curve From Time Zero to 6 Hours Post-dose (AUC[0-6]) for Total Epinephrine |
NCT01188577 (6) [back to overview] | Concentration vs. Time for Total Epinephrine From Time Zero to 6 Hours Post-dose |
NCT01243112 (2) [back to overview] | Length of Action |
NCT01243112 (2) [back to overview] | Onset of Action |
NCT01276821 (7) [back to overview] | Mean Change in Clinical Severity Score |
NCT01276821 (7) [back to overview] | Relapse Rate |
NCT01276821 (7) [back to overview] | Persistence of Cough at the End of 1 Week |
NCT01276821 (7) [back to overview] | Need for Unscheduled Medical Visits, if Any, for Same Symptoms to Any Healthcare Facility Within 1 Week |
NCT01276821 (7) [back to overview] | Missed Days of Work of Caregivers |
NCT01276821 (7) [back to overview] | Average Duration of Crying (in Minutes) Among Babies Receiving Nebulisation Therapy. |
NCT01276821 (7) [back to overview] | Patients Meeting Eligibility Criteria for ER/ OPD Discharge at the End of 2 Hours of Observation |
NCT01395043 (2) [back to overview] | Opioid Requirements Postoperative |
NCT01395043 (2) [back to overview] | Postoperative Pain Using Numerical Rating Scale (NRS) 0-10 |
NCT01402869 (3) [back to overview] | Time to Peak Methemoglobin Blood Levels |
NCT01402869 (3) [back to overview] | Peak Methemoglobin Blood Levels |
NCT01402869 (3) [back to overview] | Delta Methemoglobin Blood Level |
NCT01479270 (4) [back to overview] | Intraoperative Time |
NCT01479270 (4) [back to overview] | Narcotic Use |
NCT01479270 (4) [back to overview] | Visual Analog Scale (VAS) for Pain |
NCT01479270 (4) [back to overview] | Quality of Recovery Questionnaire (QoR-40) on Postop Day #1 or #2 |
NCT01583166 (4) [back to overview] | Number of Subjects Who Passed the Voiding Trial After a Midurethral Sling |
NCT01583166 (4) [back to overview] | Post-operative Pain Scale at 6-7 Hours Post op |
NCT01583166 (4) [back to overview] | Post-operative Pain Scores at 2-3 Hours Post op |
NCT01583166 (4) [back to overview] | Visual Analog Scale for Pain: Pre-operative. |
NCT01602692 (7) [back to overview] | Anti-emetic / Intraoperative Medication Administered (mg) |
NCT01602692 (7) [back to overview] | Amount of Post-Operative Narcotic Medication Administered |
NCT01602692 (7) [back to overview] | Unplanned Hospital Readmission |
NCT01602692 (7) [back to overview] | Time to Discharge |
NCT01602692 (7) [back to overview] | Anti-emetic / Intraoperative Fentanyl Administered (Measured in Micrograms) |
NCT01602692 (7) [back to overview] | Post-operative Pain |
NCT01602692 (7) [back to overview] | Post Operative Nausea and Vomiting |
NCT01622296 (1) [back to overview] | Participant Pain Experience After Administration of Local Anesthesia to Numb the Gums and Teeth During Dental Treatment |
NCT01700192 (7) [back to overview] | Number of Participants Who Discontinue Study Drug Due to an AE |
NCT01700192 (7) [back to overview] | Average Total Combined Rhinoconjunctivitis Score (TCS) During Last 8 Weeks of Treatment |
NCT01700192 (7) [back to overview] | Average Total Combined Rhinitis Score (TCRS) During Last 8 Weeks of Treatment |
NCT01700192 (7) [back to overview] | Average Rhinitis Daily Symptom Score (Rhinitis DSS) During Last 8 Weeks of Treatment |
NCT01700192 (7) [back to overview] | Average Rhinitis Daily Medication Score (Rhinitis DMS) During Last 8 Weeks of Treatment |
NCT01700192 (7) [back to overview] | Average Allergic Rhinitis/Rhinoconjunctivitis Symptoms Assessed by Visual Analogue Scale (VAS) During Last 8 Weeks of Treatment |
NCT01700192 (7) [back to overview] | Number of Participants Who Experience At Least One Adverse Event (AE) |
NCT01705964 (5) [back to overview] | Disposition |
NCT01705964 (5) [back to overview] | Change in Percent of Predicted PEFR at t120 |
NCT01705964 (5) [back to overview] | Change in Percent of Predicted Peak Expiratory Flow Rate (PEFR) at t15 |
NCT01705964 (5) [back to overview] | Breaths Per Minute at t120 |
NCT01705964 (5) [back to overview] | Heart Rate at t120 |
NCT01706952 (4) [back to overview] | Heart Rate |
NCT01706952 (4) [back to overview] | Blood Pressure |
NCT01706952 (4) [back to overview] | End Tidal CO2 |
NCT01706952 (4) [back to overview] | To Estimate the Change in Bleeding Category (Surgical Field Improvement) as Measured on a Six-point Scale, Measured From 0 (Best Case) to 5 (Worst Case). |
NCT01759407 (3) [back to overview] | Time to First Opioid Dose |
NCT01759407 (3) [back to overview] | Post-anesthesia Care Unit (PACU) Pain Scores |
NCT01759407 (3) [back to overview] | Intraoperative End-tidal Isoflurane % |
NCT01800877 (1) [back to overview] | MAP While on Vasopressors |
NCT01829399 (2) [back to overview] | Time in Minutes That Tq Remained Inflated |
NCT01829399 (2) [back to overview] | Pain Score at Time of Tq Deflation |
NCT01862614 (1) [back to overview] | Number of Participants Achieving Pulpal Anesthesia. |
NCT01966263 (3) [back to overview] | Six Minute Walking Test (6MWT) |
NCT01966263 (3) [back to overview] | Stair Climbing Task (SCT) |
NCT01966263 (3) [back to overview] | Timed Up and Go Test (TUG) |
NCT01981772 (2) [back to overview] | Pain Measurement as Assessed on a Heft-Parker 170 mm Visual Analog Scale |
NCT01981772 (2) [back to overview] | Postoperative Satisfaction on a 100 mm Visual Analog Scale |
NCT02007434 (11) [back to overview] | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire |
NCT02007434 (11) [back to overview] | Change From Baseline in Submental Skin Laxity Grades (SMSLG) |
NCT02007434 (11) [back to overview] | Bruising Grading Scale Scores |
NCT02007434 (11) [back to overview] | Change From Baseline in Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) |
NCT02007434 (11) [back to overview] | Change From Baseline in Pain Visual Analog Scale Scores |
NCT02007434 (11) [back to overview] | Change From Baseline in Patient-Reported Submental Fat Rating Scale (PR-SMFRS) |
NCT02007434 (11) [back to overview] | Change From Baseline in Subject Self Rating Scale (SSRS) |
NCT02007434 (11) [back to overview] | Change From Baseline in Submental Fat Thickness |
NCT02007434 (11) [back to overview] | Induration Grading Scale Scores |
NCT02007434 (11) [back to overview] | Swelling Grading Scale Scores |
NCT02007434 (11) [back to overview] | Patient Experience Questions |
NCT02104414 (6) [back to overview] | Post Operative Pain Control |
NCT02104414 (6) [back to overview] | Number of Participants With Urinary Retention |
NCT02104414 (6) [back to overview] | Postoperative Opioid Consumption - Hydromorphone I.V |
NCT02104414 (6) [back to overview] | Number of Participants With Pain During Bowel Movements |
NCT02104414 (6) [back to overview] | Number of Participants With Postoperative Nausea and Vomiting |
NCT02104414 (6) [back to overview] | Number of Oxycodone Tablets Taken |
NCT02112370 (8) [back to overview] | Operation Time |
NCT02112370 (8) [back to overview] | Pain Killer Dose |
NCT02112370 (8) [back to overview] | NRS Change |
NCT02112370 (8) [back to overview] | NRS Pain Scores for the First 12 Hours |
NCT02112370 (8) [back to overview] | Blood Loss Amount |
NCT02112370 (8) [back to overview] | Maximum of Measured Diastolic Blood Pressures |
NCT02112370 (8) [back to overview] | Maximum of Measured Heart Rates |
NCT02112370 (8) [back to overview] | Maximum of Measured Systolic Blood Pressures |
NCT02116309 (2) [back to overview] | Number of Patients Who Developed Post-ERCP Pancreatitis |
NCT02116309 (2) [back to overview] | Number of Patients Who Developed Severe Post-ERCP Pancreatitis |
NCT02164929 (8) [back to overview] | Quality of Recovery |
NCT02164929 (8) [back to overview] | Time to First Bowel Movement |
NCT02164929 (8) [back to overview] | Time to First Ingestion of Solid Food |
NCT02164929 (8) [back to overview] | Opioid Related Side Effects |
NCT02164929 (8) [back to overview] | Length of Stay |
NCT02164929 (8) [back to overview] | Number of Epidural-related Side Effects |
NCT02164929 (8) [back to overview] | Pain Scores |
NCT02164929 (8) [back to overview] | Postoperative Opioid Consumption |
NCT02197273 (3) [back to overview] | Length of Stay in Hospital (Days) |
NCT02197273 (3) [back to overview] | Readmission or Emergency Department (ED) Visit Due to Pain Control Within 30 Days |
NCT02197273 (3) [back to overview] | Time to Post-operative Rescue Opioids (Hours) |
NCT02242201 (9) [back to overview] | Change in Short Form-36 (SF-36) Quality of Life Mental Component |
NCT02242201 (9) [back to overview] | Post-Operative Pain Score |
NCT02242201 (9) [back to overview] | Maximum Postoperative Pain Score |
NCT02242201 (9) [back to overview] | Number of Participants Reporting Complications Since Surgery |
NCT02242201 (9) [back to overview] | Total Opioid Consumption During Hospitalization |
NCT02242201 (9) [back to overview] | Number of Participants Reporting a NRS Pain Score Greater Than 3 |
NCT02242201 (9) [back to overview] | Change in Unipedal Stance Time |
NCT02242201 (9) [back to overview] | Hospital Length of Stay |
NCT02242201 (9) [back to overview] | Change in Short Form-36 (SF-36) Quality of Life Physical Component |
NCT02285634 (4) [back to overview] | Change in Heart Rate |
NCT02285634 (4) [back to overview] | Change in Diastolic Blood Pressure |
NCT02285634 (4) [back to overview] | Change in Systolic Blood Pressure |
NCT02285634 (4) [back to overview] | Change in Mean Arterial Blood Pressure |
NCT02299349 (2) [back to overview] | Pain Scores (Visual Analog Pain Scores) |
NCT02299349 (2) [back to overview] | MS04 Equivalent Consumption |
NCT02365961 (5) [back to overview] | Hospital Readmission |
NCT02365961 (5) [back to overview] | Visual Analog Scale |
NCT02365961 (5) [back to overview] | Total Number of Episodes of Nausea and Vomiting |
NCT02365961 (5) [back to overview] | Time in PACU |
NCT02365961 (5) [back to overview] | Opioid Consumption |
NCT02369510 (7) [back to overview] | Block Onset |
NCT02369510 (7) [back to overview] | Motor Recovery |
NCT02369510 (7) [back to overview] | Patient Satisfaction |
NCT02369510 (7) [back to overview] | Sensory Recovery |
NCT02369510 (7) [back to overview] | Incidence of Nausea and Vomiting |
NCT02369510 (7) [back to overview] | Adequacy of Anesthesia |
NCT02369510 (7) [back to overview] | Number of Participants With Hypotension |
NCT02379221 (6) [back to overview] | Participants Anesthetic Preference |
NCT02379221 (6) [back to overview] | Mean Pain Level Associated With Facial Filler Injection to the Nasolabial Fold |
NCT02379221 (6) [back to overview] | Mean Pain Level Associated With Facial Filler Injection to the Lower Lip |
NCT02379221 (6) [back to overview] | Mean Pain Level Associated With Facial Filler Injection at the Upper Lip |
NCT02379221 (6) [back to overview] | Mean Pain Level Associated With the Local Anesthetic Injection |
NCT02379221 (6) [back to overview] | Mean Pain Level Associated With the Local Topical Anesthetic |
NCT02462148 (6) [back to overview] | Rate of Post Operative Nausea and Vomiting |
NCT02462148 (6) [back to overview] | Time to First Opioid Analgesic Request |
NCT02462148 (6) [back to overview] | Verbal Pain Scores |
NCT02462148 (6) [back to overview] | Duration of Sensory Nerve Block |
NCT02462148 (6) [back to overview] | Neurologic Complications |
NCT02462148 (6) [back to overview] | Post Operative Opioid Use and Consumption |
NCT02464176 (4) [back to overview] | Time to First Analgesic Request |
NCT02464176 (4) [back to overview] | Duration of Sensory Blockade |
NCT02464176 (4) [back to overview] | Verbal Numeric Pain Score Comparisons |
NCT02464176 (4) [back to overview] | Total Opioid Consumption |
NCT02478398 (7) [back to overview] | Percentage of Participants Reporting Anaphylaxis and/or Systemic Allergic Reactions |
NCT02478398 (7) [back to overview] | Total Combined Score (TCS) During the Peak Ragweed Season (RS) |
NCT02478398 (7) [back to overview] | Percentage of Participants Treated With Epinephrine |
NCT02478398 (7) [back to overview] | Percentage of Participants Reporting Pre-specified Local Application Site Reactions |
NCT02478398 (7) [back to overview] | Average TCS During the Entire RS |
NCT02478398 (7) [back to overview] | Average Rhinoconjunctivitis (RC) DSS During the Peak RS |
NCT02478398 (7) [back to overview] | Average Rhinoconjunctivitis (RC) DMS During the Peak RS |
NCT02519023 (14) [back to overview] | Maximum Pain Scores as Measured by Numerical Pain Rating Scale (0-10) |
NCT02519023 (14) [back to overview] | Number of Patients Admitted Post Operatively |
NCT02519023 (14) [back to overview] | Overall Benefit of Analgesia Score (OBAS) |
NCT02519023 (14) [back to overview] | Maximal Pain Score for Patient From Time 24-48 Hours After Surgery |
NCT02519023 (14) [back to overview] | Total Opioid Use for Pain Control |
NCT02519023 (14) [back to overview] | Length of Time in Phase 1 and Phase 2 of Recovery |
NCT02519023 (14) [back to overview] | Patient Satisfaction With Pain Management |
NCT02519023 (14) [back to overview] | Maximal Pain Score Patient Felt From 48-72 Hours After Surgery |
NCT02519023 (14) [back to overview] | Maximal Pain Score of Patient From Time 0-24 Hours After Surgery |
NCT02519023 (14) [back to overview] | Number of Participants With Nausea and Vomiting |
NCT02519023 (14) [back to overview] | Quality of Recovery 15 (QoR15) Score |
NCT02519023 (14) [back to overview] | Total Opioid Taken by Patient as Tabulated and Converted to Morphine Equivalents |
NCT02519023 (14) [back to overview] | Total Opioid Taken by Patient as Tabulated and Converted to Morphine Equivalents |
NCT02519023 (14) [back to overview] | Opioid Used From 24-48 Hours Post Surgery |
NCT02525718 (4) [back to overview] | Opioid Consumption |
NCT02525718 (4) [back to overview] | Length of Hospital Stay |
NCT02525718 (4) [back to overview] | Pain Score Using 10-point Visual Analog Scale (VAS) |
NCT02525718 (4) [back to overview] | Quality of Recovery Score |
NCT02538679 (1) [back to overview] | Morphine Requirement |
NCT02543801 (3) [back to overview] | Length of Stay |
NCT02543801 (3) [back to overview] | Narcotic Consumption |
NCT02543801 (3) [back to overview] | Pain Score |
NCT02570503 (1) [back to overview] | Narcotic Use During Hospitalization |
NCT02658149 (5) [back to overview] | Pain Score at 3-24 Hours |
NCT02658149 (5) [back to overview] | Pain Score at 3 Hours |
NCT02658149 (5) [back to overview] | Pain Score at 24-48 Hours |
NCT02658149 (5) [back to overview] | Opioid Usage In-hospital at 48 Hours |
NCT02658149 (5) [back to overview] | Opioid Usage In-hospital at 24 Hours |
NCT02658240 (4) [back to overview] | Oral Morphine Equivalents of Postoperative Opioid Requirements for 48 Hours |
NCT02658240 (4) [back to overview] | Postoperative Pain Score at Resting |
NCT02658240 (4) [back to overview] | Postoperative Pain Score With Movement |
NCT02658240 (4) [back to overview] | The Time to Ambulation |
NCT02659501 (5) [back to overview] | The Effect of Liposomal Bupivacaine on Average Postoperative Pain Levels on Postoperative Day 1. |
NCT02659501 (5) [back to overview] | The Effect of Liposomal Bupivacaine on Postoperative Opioid Consumption |
NCT02659501 (5) [back to overview] | The Effect of Liposomal Bupivacaine on Length of Hospital Stay |
NCT02659501 (5) [back to overview] | The Effect of Liposomal Bupivacaine on Postoperative Diazepam Consumption |
NCT02659501 (5) [back to overview] | The Effect of Liposomal Bupivacaine on Antiemetic Consumption |
NCT02701296 (6) [back to overview] | Sensation in the Peroneal Nerve Distribution |
NCT02701296 (6) [back to overview] | Pain Intensity |
NCT02701296 (6) [back to overview] | Dorsiflexion in the Peroneal Nerve Distribution |
NCT02701296 (6) [back to overview] | Cold Sensation in the Tibial Nerve Distribution |
NCT02701296 (6) [back to overview] | Opioid Consumption |
NCT02701296 (6) [back to overview] | Plantar Flexion in the Tibial Nerve Distribution |
NCT02701582 (9) [back to overview] | Area Under Curve of MAP Below 65 |
NCT02701582 (9) [back to overview] | Creatinine Change |
NCT02701582 (9) [back to overview] | Fluid Balance Measured by Inputs and Outputs (I/Os) of All Measurable Fluid in Peri-operative Period |
NCT02701582 (9) [back to overview] | Pulmonary Status as Measured by the Number of Participants Who Require Supplemental Oxygen |
NCT02701582 (9) [back to overview] | Patients Requiring Fluid Bolus for Management |
NCT02701582 (9) [back to overview] | Organ Oxygenation as Measured by Serum Lactate |
NCT02701582 (9) [back to overview] | Organ Oxygenation as Measured by Arterial Blood Gas Values |
NCT02701582 (9) [back to overview] | Number of Patients Treated for Hypotension With Phenylephrine Drip |
NCT02701582 (9) [back to overview] | Number of ICU Stays Greater Than 1.5 Days |
NCT02726620 (43) [back to overview] | Timing of Cardiovascular Drugs for MAP < 60 mmHg |
NCT02726620 (43) [back to overview] | Timing of Cardiovascular Drugs for MAP < 55 mmHg |
NCT02726620 (43) [back to overview] | Timing of Cardiovascular Drugs for MAP < 50 mmHg |
NCT02726620 (43) [back to overview] | Postoperative Rise in Creatinine Levels |
NCT02726620 (43) [back to overview] | Intravenous Anesthetic Drug Use During Intraoperative Hypotension: MAP < 65 mmHg |
NCT02726620 (43) [back to overview] | Intravenous Anesthetic Drug Use During Intraoperative Hypotension: MAP < 60 mmHg |
NCT02726620 (43) [back to overview] | Intravenous Anesthetic Drug Use During Intraoperative Hypotension: MAP < 55 mmHg |
NCT02726620 (43) [back to overview] | Intraoperative Administration of Intravenous Fluids |
NCT02726620 (43) [back to overview] | Incidence of a MAP < 60 mmHg for > 20 Minutes |
NCT02726620 (43) [back to overview] | Incidence of a MAP < 60 mmHg for > 10 Minutes |
NCT02726620 (43) [back to overview] | Incidence of a MAP < 60 mmHg |
NCT02726620 (43) [back to overview] | Incidence of a MAP < 55 mmHg for > 20 Minutes |
NCT02726620 (43) [back to overview] | Incidence of a MAP < 55 mmHg for > 10 Minutes |
NCT02726620 (43) [back to overview] | Incidence of a MAP < 55 mmHg |
NCT02726620 (43) [back to overview] | Incidence of a MAP < 50 mmHg for > 20 Minutes |
NCT02726620 (43) [back to overview] | Time to Discharge Readiness at the Postanesthesia Care Unit (PACU) |
NCT02726620 (43) [back to overview] | Incidence of a MAP < 50 mmHg for > 10 Minutes |
NCT02726620 (43) [back to overview] | Incidence of a MAP < 50 mmHg |
NCT02726620 (43) [back to overview] | In-hospital Mortality |
NCT02726620 (43) [back to overview] | Estimated Intraoperative Blood Loss |
NCT02726620 (43) [back to overview] | Depth and Duration of Intraoperative Hypotension - Threshold MAP 75 mmHg |
NCT02726620 (43) [back to overview] | Depth and Duration of Intraoperative Hypotension - Threshold MAP 70 mmHg |
NCT02726620 (43) [back to overview] | Depth and Duration of Intraoperative Hypotension - Threshold MAP 65 mmHg |
NCT02726620 (43) [back to overview] | Depth and Duration of Intraoperative Hypotension - Threshold MAP 60 mmHg |
NCT02726620 (43) [back to overview] | Depth and Duration of Intraoperative Hypotension - Threshold MAP 55 mmHg |
NCT02726620 (43) [back to overview] | Average Use of Cardiovascular Drugs: Glycopyrrolate |
NCT02726620 (43) [back to overview] | Depth and Duration of Intraoperative Hypotension - Threshold MAP 50 mmHg |
NCT02726620 (43) [back to overview] | Average Use of Cardiovascular Drugs: Phenylephrine |
NCT02726620 (43) [back to overview] | Average Use of Cardiovascular Drugs: Norepinephrine |
NCT02726620 (43) [back to overview] | Average Use of Cardiovascular Drugs: Epinephrine |
NCT02726620 (43) [back to overview] | Average Use of Cardiovascular Drugs: Ephedrine |
NCT02726620 (43) [back to overview] | 30-day Mortality |
NCT02726620 (43) [back to overview] | Intravenous Anesthetic Drug Use During Intraoperative Hypotension: MAP < 50 mmHg |
NCT02726620 (43) [back to overview] | Inhaled Anesthetic Drug Use During Intraoperative Hypotension: MAP < 65 mmHg |
NCT02726620 (43) [back to overview] | Inhaled Anesthetic Drug Use During Intraoperative Hypotension: MAP < 60 mmHg |
NCT02726620 (43) [back to overview] | Inhaled Anesthetic Drug Use During Intraoperative Hypotension: MAP < 55 mmHg |
NCT02726620 (43) [back to overview] | Inhaled Anesthetic Drug Use During Intraoperative Hypotension: MAP < 50 mmHg |
NCT02726620 (43) [back to overview] | Usage Frequency of Cardiovascular Drugs: Phenylephrine |
NCT02726620 (43) [back to overview] | Usage Frequency of Cardiovascular Drugs: Norepinephrine |
NCT02726620 (43) [back to overview] | Usage Frequency of Cardiovascular Drugs: Glycopyrrolate |
NCT02726620 (43) [back to overview] | Usage Frequency of Cardiovascular Drugs: Ephinephrine |
NCT02726620 (43) [back to overview] | Usage Frequency of Cardiovascular Drugs: Ephedrine |
NCT02726620 (43) [back to overview] | Timing of Cardiovascular Drugs for MAP < 65 mmHg |
NCT02740127 (3) [back to overview] | Post-operative Pain the First 24hrs |
NCT02740127 (3) [back to overview] | Post-Operative Pain Medication Usage in Post Anesthesia Care Unit (PACU) |
NCT02740127 (3) [back to overview] | Length of Hospital Stay |
NCT02741713 (5) [back to overview] | Percentage of Participants With Episodes of Nausea or Vomiting |
NCT02741713 (5) [back to overview] | Post-operative Axillary Pain |
NCT02741713 (5) [back to overview] | Time From Block Placement to Onset of Axillary Pain |
NCT02741713 (5) [back to overview] | Total Opioid Usage |
NCT02741713 (5) [back to overview] | Numerical Rating Scale Pain Scores (0-10) at Rest |
NCT02793947 (3) [back to overview] | Total Narcotic Consumption |
NCT02793947 (3) [back to overview] | Number of Participants With Medication-related Side Effects |
NCT02793947 (3) [back to overview] | Visual Analog Scale Pain Assessment |
NCT02895035 (4) [back to overview] | Maximum Intraoperative Change in Pupil Diameter |
NCT02895035 (4) [back to overview] | Number of Eyes With Pupil Diameter Less Than 6 mm During Cortical Clean-up |
NCT02895035 (4) [back to overview] | Number of Eyes With Pupil Diameter Less Than 6 mm at Any Time During Surgery |
NCT02895035 (4) [back to overview] | Mean Area Under the Curve Change From Baseline in Pupil Diameter Over Time to the End of Cataract Surgery |
NCT02909140 (9) [back to overview] | Pupil Size (mm) Immediately After Nuclear Disassembly |
NCT02909140 (9) [back to overview] | Pupil Size Immediately Prior to Intraocular Lens (IOL) Insertion |
NCT02909140 (9) [back to overview] | Pupil Size Upon Completion of Surgery |
NCT02909140 (9) [back to overview] | Percentage of Patients in Each Arm That Required Another Mydriatic Agent |
NCT02909140 (9) [back to overview] | Pupil Size Immediately Prior to Capsulorrhexis |
NCT02909140 (9) [back to overview] | Mean Time Taken to Perform Phacoemulsification in Each Arm |
NCT02909140 (9) [back to overview] | Cumulative Energy Dispersed for Each Arm |
NCT02909140 (9) [back to overview] | Mean Time Taken to Perform Phacoemulsification |
NCT02909140 (9) [back to overview] | Percentage of Patients in Each Arm That Required Use of an Iris Expansion Device During the Procedure |
NCT02967172 (4) [back to overview] | Opioid Use in First 24 Hours Post-surgery |
NCT02967172 (4) [back to overview] | Change in Post-operative Visual Analog Pain Scores (VAS) |
NCT02967172 (4) [back to overview] | Post-operative Length of Stay |
NCT02967172 (4) [back to overview] | Patients Returning Home Following Surgery |
NCT02988050 (1) [back to overview] | Patients Satisfaction |
NCT02988219 (2) [back to overview] | The Prevention of Cardiac Arrhythmias Occurence by Epidural Anesthesia Added to General Anesthesia Evaluated by a Number and Type of Arrhythmias Observed |
NCT02988219 (2) [back to overview] | Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative Period |
NCT03001453 (5) [back to overview] | Change in Patient-reported Visual Analog Scale (VAS) Pain Intensity Score |
NCT03001453 (5) [back to overview] | Number of Patients That Experienced a Fall |
NCT03001453 (5) [back to overview] | Length of Stay (LOS, in Days) |
NCT03001453 (5) [back to overview] | Patient Morphine Equivalent Consumption |
NCT03001453 (5) [back to overview] | Time to Ambulation More Than 20 Feet (in Hours) |
NCT03007966 (12) [back to overview] | Number of Participants With Presence of Opioid Related Side Effects--Itching |
NCT03007966 (12) [back to overview] | Number of Participants With Presence of Opioid Related Side Effects--Nausea |
NCT03007966 (12) [back to overview] | Number of Participants With Presence of Opioid Related Side Effects--Nausea |
NCT03007966 (12) [back to overview] | Number of Participants With Presence of Opioid Related Side Effects--Vomiting |
NCT03007966 (12) [back to overview] | Number of Participants With Presence of Opioid Related Side Effects--Vomiting |
NCT03007966 (12) [back to overview] | Post-operative Verbal Pain Score at Rest |
NCT03007966 (12) [back to overview] | Post-operative Verbal Pain Score With Activity |
NCT03007966 (12) [back to overview] | Post-operative Verbal Pain Score With Movement |
NCT03007966 (12) [back to overview] | Time to First Oral Analgesic |
NCT03007966 (12) [back to overview] | Total Opioid Consumption |
NCT03007966 (12) [back to overview] | Post-operative Verbal Pain Score at Rest |
NCT03007966 (12) [back to overview] | Number of Participants With Presence of Opioid Related Side Effects--Itching |
NCT03011333 (2) [back to overview] | Mean Total Postoperative Opioid Consumption (in Morphine Equivalents) |
NCT03011333 (2) [back to overview] | Mean Area Under the Curve (AUC) of the NRS-A (Windowed Worst Observation Carried Forward) Pain Intensity Scores |
NCT03020407 (5) [back to overview] | 72-hour Cumulative Amount of Intravenous Fluid (mL) After Treatment |
NCT03020407 (5) [back to overview] | Change in Sequential Organ Failure Assessment (SOFA) Score in 72 Hours After Treatment |
NCT03020407 (5) [back to overview] | 30-day Mortality |
NCT03020407 (5) [back to overview] | 6-hour Cumulative Amount of Intravenous Fluid (mL) |
NCT03020407 (5) [back to overview] | Percentage Change of 6-hour Lactate |
NCT03087604 (2) [back to overview] | Time Required to Place the Epidural Catheter |
NCT03087604 (2) [back to overview] | Success Rate of Placement of a Thoracic Epidural |
NCT03119181 (1) [back to overview] | Subject-reported Visual Analog Scale (VAS) Pain Score Following Tympanic Membrane Tap for Subjects Treated With Active Tymbion Iontophoresis Compared to VAS Score for Subjects Treated With Sham Tymbion Iontophoresis. |
NCT03228914 (1) [back to overview] | Surgical Field Visualization During Sinus Surgery as Indicated by Score on Boezaart Grading Scale |
NCT03366298 (4) [back to overview] | Plasma Catecholamine Levels (Maximum Concentration, Area-under-curve (AUC)) |
NCT03366298 (4) [back to overview] | Plasma Catecholamine Levels (Maximum Concentration, Cmax) |
NCT03366298 (4) [back to overview] | Plasma Catecholamine Levels (Time to Maximum Concentration, Tmax) |
NCT03366298 (4) [back to overview] | Adverse Events Following Self-administration of Adrenaline Via Autoinjector Device |
NCT03383588 (1) [back to overview] | Amount of Supplemental Oxycodone Used |
NCT03408483 (11) [back to overview] | Opioid Consumption (Oral Morphine Equivalents) |
NCT03408483 (11) [back to overview] | Pain Scores Using Visual Analog Scale (VAS) Scores |
NCT03408483 (11) [back to overview] | Pain Scores Using Visual Analog Scale (VAS) Scores |
NCT03408483 (11) [back to overview] | Pain Scores Using Visual Analog Scale (VAS) Scores |
NCT03408483 (11) [back to overview] | Pain Scores Using Visual Analog Scale (VAS) Scores |
NCT03408483 (11) [back to overview] | Patient Satisfaction |
NCT03408483 (11) [back to overview] | Distance Ambulated |
NCT03408483 (11) [back to overview] | Distance Ambulated |
NCT03408483 (11) [back to overview] | Hours to Hospital Discharge |
NCT03408483 (11) [back to overview] | Opioid Consumption (Oral Morphine Equivalents) |
NCT03408483 (11) [back to overview] | Opioid Consumption (Oral Morphine Equivalents) |
NCT03562481 (4) [back to overview] | Mean Time to Lower Lip Numbness Following Injection |
NCT03562481 (4) [back to overview] | Mean Time to Baseline Lip Sensation |
NCT03562481 (4) [back to overview] | Mean Pain Scores Following Injection |
NCT03562481 (4) [back to overview] | Average Serum Lidocaine Concentration at 15 Minutes Post Injection |
NCT03661996 (8) [back to overview] | Mean Change From Baseline in Average Daily Pain With Walking NPRS (0-10) Score by Subject Type |
NCT03661996 (8) [back to overview] | Determination of Optimal Procedure for Administering CNTX-4975-05 With Regards to Pain, Participant Satisfaction, and Investigator's Satisfaction |
NCT03661996 (8) [back to overview] | "Mean Change From Baseline in KOOS Symptoms Subscale Score by Subject Type" |
NCT03661996 (8) [back to overview] | "Mean Change From Baseline in KOOS Pain With Walking Single Question Score by Subject Type" |
NCT03661996 (8) [back to overview] | "Mean Change From Baseline in KOOS Pain Subscale Score by Subject Type" |
NCT03661996 (8) [back to overview] | "Mean Change From Baseline in KOOS Knee-Related Quality of Life Subscale Score by Subject Type" |
NCT03661996 (8) [back to overview] | "Mean Change From Baseline in KOOS Function (Sport and Recreational Activities) Subscale Score by Subject Type" |
NCT03661996 (8) [back to overview] | "Mean Change From Baseline in KOOS Function (Daily Living) Subscale Score by Subject Type" |
NCT03682224 (9) [back to overview] | VAS Pain Score |
NCT03682224 (9) [back to overview] | Mortality |
NCT03682224 (9) [back to overview] | Treatment Cost |
NCT03682224 (9) [back to overview] | Total Morphine Equivalents Consumed |
NCT03682224 (9) [back to overview] | Prolonged Air Leak |
NCT03682224 (9) [back to overview] | Pharmacy Cost |
NCT03682224 (9) [back to overview] | Hospital Stay |
NCT03682224 (9) [back to overview] | Atrial Fibrillation/Other Arrhythmia |
NCT03682224 (9) [back to overview] | Pneumothorax |
NCT03723447 (4) [back to overview] | Cumulative 48-hour Post Surgical Opiate Use (Oral Morphine Equivalent) |
NCT03723447 (4) [back to overview] | Post-op Pain Score (Visual Analog Scale) |
NCT03723447 (4) [back to overview] | Postoperative Length of Stay |
NCT03723447 (4) [back to overview] | Bowel Motility |
NCT03887650 (10) [back to overview] | Assessment of Patient Overall Satisfaction With Pain Control |
NCT03887650 (10) [back to overview] | Pain Assessment at Post Anesthesia Care Unit (PACU)-96 Postoperative Hours |
NCT03887650 (10) [back to overview] | Day of the Final Opioids Used |
NCT03887650 (10) [back to overview] | Hospital Length-of-stay |
NCT03887650 (10) [back to overview] | Time to First Opioid Medication |
NCT03887650 (10) [back to overview] | Total Opioid Consumption |
NCT03887650 (10) [back to overview] | Motor Recovery |
NCT03887650 (10) [back to overview] | Incidence of Distress From Block Numbness |
NCT03887650 (10) [back to overview] | Duration of Sensory Nerve Block |
NCT03887650 (10) [back to overview] | Total Amount of Opioid Consumed During the Indicated Time Periods |
NCT04023695 (2) [back to overview] | Pain Outcome: Visual Analog Scale |
NCT04023695 (2) [back to overview] | Pain Outcome: Visual Analog Scale |
NCT04065451 (6) [back to overview] | en Bloc Resection |
NCT04065451 (6) [back to overview] | Frequency of Immediate Bleeding |
NCT04065451 (6) [back to overview] | Quality of the Mound |
NCT04065451 (6) [back to overview] | Immediate Post-polypectomy Pain |
NCT04065451 (6) [back to overview] | Immediate Post Polypectomy Pain (1hour) |
NCT04065451 (6) [back to overview] | Sydney Resection Quotient |
NCT04203225 (2) [back to overview] | Need for Additional Local Anesthetic |
NCT04203225 (2) [back to overview] | Visual Analog Scale Pain Score |
NCT04207840 (6) [back to overview] | C[Max], Maximum Plasma Concentration of Albuterol or Epinephrine |
NCT04207840 (6) [back to overview] | AUC(0-tm)_TOT, Area Under the Curve (AUC) of Total (Exogenous and Endogenous, if Available) Active Product Ingredient (API) From Time 0 to Time (tm) |
NCT04207840 (6) [back to overview] | AUC(0-tm)_DE, Area Under the Curve (AUC) of Exogenous Active Product Ingredient (API) From Time 0 to Time (tm) |
NCT04207840 (6) [back to overview] | AUC(0-inf), Area Under the Curve (AUC) of Albuterol or Epinephrine From Time 0 to Infinity |
NCT04207840 (6) [back to overview] | t[Max], Time at Which Maximum Plasma Concentration of Albuterol or Epinephrine is Observed |
NCT04207840 (6) [back to overview] | t[1/2], Terminal Elimination Half-life of Albuterol or Epinephrine |
NCT04369950 (8) [back to overview] | Time Until First Opioid Request |
NCT04369950 (8) [back to overview] | Total Amount of Opioid Used |
NCT04369950 (8) [back to overview] | Total Amount of Opioid Used |
NCT04369950 (8) [back to overview] | Total Amount of Opioid Used |
NCT04369950 (8) [back to overview] | Total Amount of Opioid Used |
NCT04369950 (8) [back to overview] | Number of Participants Who Had Mild, Moderate or Severe Nausea as Measured by a 3 Point Scale |
NCT04369950 (8) [back to overview] | Number of Participants Who Had Mild, Moderate or Severe Pruritis as Measured by a 3 Point Scale |
NCT04369950 (8) [back to overview] | Pain as Measured by a 11 Point Verbal Scale |
NCT04688346 (3) [back to overview] | Hemostasis Efficacy |
NCT04688346 (3) [back to overview] | Cardiovascular Outcomes |
NCT04688346 (3) [back to overview] | Cardiovascular Outcomes |
NCT05244525 (6) [back to overview] | Total Operative Time |
NCT05244525 (6) [back to overview] | Surgeon-rated Visual Clarity as Assessed by the Visual Analog Scale |
NCT05244525 (6) [back to overview] | Percentage of Participants for Whom Intra-operative Arthroscopic Pump Pressure Was Increased to 45mmHg or Higher During the Surgical Procedure |
NCT05244525 (6) [back to overview] | Number of Subjects Who Experience Intraoperative Adverse Events |
NCT05244525 (6) [back to overview] | Intraoperative Mean Arterial Pressure |
NCT05244525 (6) [back to overview] | Number of Subjects Who Experience Post Operative Adverse Events |
NCT05439460 (1) [back to overview] | Change in Systemic Vascular Resistance Index (SVRI) to Pulmonary Vascular Resistance Index (PVRI) Ratio (Rp:Rs Ratio) |
NCT05867342 (7) [back to overview] | Number of Nostrils With Continuous Fresh Bleeding |
NCT05867342 (7) [back to overview] | Postoperative Bloody Discharge Grading Score |
NCT05867342 (7) [back to overview] | Surgical Field Grading Score |
NCT05867342 (7) [back to overview] | Estimated Blood Loss During Surgery |
NCT05867342 (7) [back to overview] | Number of Days With Postoperative Bloody Nasal Discharge |
NCT05867342 (7) [back to overview] | Duration of Surgery |
NCT05867342 (7) [back to overview] | Number of Extra Pledgets Used |
Visual Analogue Scale (VAS) Pain Score
Visual Analogue Scale (VAS) pain score on a scale from 0 (None) to 10 (Worst) points. (NCT00318292)
Timeframe: 30 minutes post-op
Intervention | points on a scale (Mean) |
---|
Preemptive Local Analgesia (PLA) | 2.5 |
Placebo | 4.4 |
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Return of Spontaneous Circulation.
Return of spontaneous circulation is defined as the presence of any palpable pulse detected by manual palpation of a major artery. This is measured as number of participants who had return of spontaneous circulation during resuscitation. (NCT00358579)
Timeframe: during resuscitation
Intervention | Participants (Number) |
---|
Adrenaline | 106 |
Vasopressin | 119 |
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Neurological Status on Discharge or at 30 Days Post Arrest, if Not Discharged.
Neurological status is assessed by the Glasgow-Pittsburgh outcome categories, to evaluate quality of life after successful resuscitation. Good neurological status is defined as cerebral performance categories(CPC)/overall performance categories(OPC):1 and 2.CPC/OPC 1 indicates good cerebral & overall performance. CPC/OPC 2 indicates moderate cerebral & overall disability. CPC/OPC 3 indicates severe cerebral & overall disability. CPC/OPC 4 indicates coma, vegetative state. CPC/OPC 5 indicates brain dead/death. (NCT00358579)
Timeframe: at 30 days post arrest
Intervention | Participants (Number) |
---|
| Cerebral Performance Categories 1 | Cerebral Performance Categories 2 | Overall Performance Categories 1 | Overall Performance Categories 2 |
---|
Adrenaline | 5 | 0 | 2 | 3 |
,Vasopressin | 4 | 1 | 5 | 0 |
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Neurological Status at 1 Year.
Neurological status is assessed by the Glasgow-Pittsburgh outcome categories, to evaluate quality of life after successful resuscitation. Good neurological status is defined as cerebral performance categories(CPC)/overall performance categories(OPC): 1 and 2. CPC/OPC 1 indicates good cerebral & overall performance. CPC/OPC 2 indicates moderate cerebral & overall disability. CPC/OPC 3 indicates severe cerebral & overall disability. CPC/OPC 4 indicates coma, vegetative state. CPC/OPC 5 indicates brain dead/death. (NCT00358579)
Timeframe: at 1 year post arrest
Intervention | Participants (Number) |
---|
| Cerebral Performance Categories 1 | Cerebral Performance Categories 2 | Overall Performance Categories 1 | Overall Performance Categories 2 |
---|
Adrenaline | 5 | 0 | 3 | 2 |
,Vasopressin | 4 | 1 | 3 | 1 |
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Survival to Hospital Discharge.
Survival to hospital discharge is defined as the patient leaving the hospital alive or survival to 30 days post cardiac arrest,whichever came first. This therefore measures the number of participants who was discharged alive or survived to 30 days post cardiac arrest, whichever came first. (NCT00358579)
Timeframe: at 30 days post arrest
Intervention | Participants (Number) |
---|
Adrenaline | 8 |
Vasopressin | 11 |
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Survival to Admission.
Survival to admission is defined as the presence of pulse on admission to hospital (discharged from Emergency Department and admitted to Intensive Care Units /wards). This measures the number of participants with pulse and who were admitted to hospital. (NCT00358579)
Timeframe: No specific time frame. Survival to admission refers to sustained return of spontaneous circulation until admission and transfer of care to Intensive Care Units /wards
Intervention | Participants (Number) |
---|
Adrenaline | 59 |
Vasopressin | 83 |
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Adverse Effects
(NCT00401882)
Timeframe: 30 days
Intervention | Participants (Count of Participants) |
---|
Additional Doses of Epinephrine | 0 |
Metoprolol Instead of Additional Epinephrine Doses | 0 |
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Return of Spontaneous Circulation
The patient will be evaluated for sufficiently stable and organized rhythm and blood pressure. (NCT00401882)
Timeframe: After electrical defibrillation
Intervention | Participants (Count of Participants) |
---|
Additional Doses of Epinephrine | 0 |
Metoprolol Instead of Additional Epinephrine Doses | 1 |
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Survival to Hospital Discharge
the number of patients who are alive at hospital discharge (NCT00401882)
Timeframe: from time of arrest to discharge or death
Intervention | Participants (Count of Participants) |
---|
Additional Epinephrine Doses | 0 |
Metoprolol Instead of Additional Epinephrine Doses | 0 |
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Lung Function
Lung functions were obtained under sedation using Chloral Hydrate. Forced expiratory flows are a lung volume at which the airway pressure is equal to 30 cm H2O (V30). Forced expiratory flows are measured at 75% FVC (FEF75). Measurements were repeated post bronchodilator and again post Epinephrine. A higher Z-score reflects better lung function. (NCT00435994)
Timeframe: Baseline, Post bronchodilator (up to 10 minutes, Post-epinephrine (up to 30 minutes)
Intervention | Z score (Mean) |
---|
| Baseline | Post Bronchodilator | Post Epinephrine |
---|
Healthy Control | 0.071 | 0.186 | 0.041 |
,Respiratory Syncytial Virus | -3.179 | -3.345 | -2.430 |
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Endothelial Growth Factor (VEGF)
Analysis for VEGF level by ELISA (NCT00435994)
Timeframe: During nasal wash
Intervention | pg/dl (Mean) |
---|
Healthy Control | 183.526 |
Bronchiolitis and Respiratory Syncytial Virus-Nasal Wash Only | 568.867 |
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Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) With Activity (NRS-A) Pain Intensity Scores From 0 Through 72 Hours
"The subject's pain intensity was to be assessed with activity (NRS-A), after the subject had moved himself from a supine position in bed to a sitting up position at the edge of the bed. The subject was to respond to the following question: On a scale of 0 to 10, where 0=no pain and 10=worst possible pain, how much pain did you have while sitting up?" (NCT00485433)
Timeframe: 0 to 72 hours
Intervention | Units on a scale*hours (Mean) |
---|
Bupivacaine HCl 105mg | 298.1 |
SKY0402 Low Dose | 286.9 |
SKY0402 Middle Dose | 274.6 |
SKY0402 High Dose | 274.4 |
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Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) With Activity (NRS-A) Pain Intensity Scores Through Postoperative Day 4
"The subject's pain intensity was to be assessed with activity (NRS-A) after actively flexing the involved knee to the maximum flexion point possible. The subject was asked to respond to the following question: On a scale of 0 to 10, where 0 = no pain and 10 = worst possible pain, how much pain did you have while bending your knee?" (NCT00485693)
Timeframe: 0 to 96 hours
Intervention | Units on a scale*hours (Mean) |
---|
Bupivacaine HCl | 20.4 |
SKY0402 Low Dose | 20.7 |
SKY0402 Low-mid Dose | 19.5 |
SKY0402 High-mid Dose | 18.8 |
SKY0402 High Dose | 19.1 |
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Length of Hospital Stay
(NCT00492973)
Timeframe: days after surgery
Intervention | days (Mean) |
---|
Control Group | 3.5 |
Corticosteroid | 2.6 |
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Knee Society Scores
The Knee Society Score is on a scale of 0 to 100, with 0 being the worst possible score, and 100 being the best possible score. The Knee Society Score takes into account subjective patient reports of pain and functional ability as well as clinical measures of passive knee range of motion. (NCT00492973)
Timeframe: 3 months postoperative
Intervention | units on a scale (Mean) |
---|
Control Group | 87.1 |
Corticosteroid | 83.3 |
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Knee Range of Motion
(NCT00492973)
Timeframe: 3 months
Intervention | degrees (Mean) |
---|
Control Group | 112.5 |
Corticosteroid | 112.4 |
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Complications, Such as Infections, Hospital Readmissions, Manipulations Under Anesthesia, Etc.
(NCT00492973)
Timeframe: any point during the first postoperative year
Intervention | Number of participants with complication (Number) |
---|
Control Group | 0 |
Corticosteroid | 3 |
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Amount of Pain Medication Taken Per Day
(NCT00492973)
Timeframe: Average of 3 days after surgery
Intervention | mg/day morphine equivalant (Mean) |
---|
Control Group | 47.8 |
Corticosteroid | 46.0 |
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Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) at Rest (NRS-R) Pain Intensity Scores From 0 Through 72 Hours
"To assess pain intensity at rest (NRS-R), the subject was to assume a resting position that did not exacerbate his or her postoperative pain. The subject was to rest in this position for at least 5 minutes before responding to the following question: On a scale of 0 to 10, where 0=no pain and 10=worst possible pain, how much pain are you having right now?" (NCT00529126)
Timeframe: 0 to 72 hours
Intervention | units on a scale*hrs (Mean) |
---|
SKY0402 300mg | 175 |
SKY0402 225mg | 172 |
SKY0402 75mg | 225 |
Bupivacaine HCl | 331 |
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Time to Readiness for Discharge
Each postoperative day, discharge readiness was assessed by an orthopaedic surgeon, a pain nurse, a ward nurse, and a physiotherapist according to the following criteria: no evidence for surgical complications, VAS pain at rest ≤30 mm which is controlled by oral analgesics, ability to eat and drink, ability to walk with elbow crutches, and ability to climb ≥8 stairs. (NCT00562627)
Timeframe: up to 10 days postoperative
Intervention | days (Mean) |
---|
LIA IV (Local Infiltration Analgesia, Intravenous) | 4 |
LIA IA, (Local Infiltration Analgesia, Intra-articular) | 3.5 |
Epidural | 5.5 |
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Pain at Rest (VAS)
VAS (pain at rest) 0-100 mm. VAS 0 mm means no pain and VAS 100 mm means maximal pain. (NCT00562627)
Timeframe: 48 hours postoperative
Intervention | Units on a scale (Mean) |
---|
LIA IV (Local Infiltration Analgesia, Intravenous) | 18 |
LIA IA, (Local Infiltration Analgesia, Intra-articular) | 12 |
Epidural | 30 |
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Opioid Use
Morphine used by patient controlled analgesia. Amount of used morphine during the first 48 hours after surgery were documented in the CRF by the pain nurses. (NCT00562627)
Timeframe: 48 hours postoperative
Intervention | mg (Mean) |
---|
LIA IV (Local Infiltration Analgesia, Intravenous) | 77 |
LIA IA, (Local Infiltration Analgesia, Intra-articular) | 49 |
Epidural | 54 |
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Area Under the Curve (AUC) of the Numeric Rating Scale at Rest (NRS-R) Pain Intensity Scores
"To assess pain intensity at rest (NRS-R), the subject was to assume a resting position that did not exacerbate his or her postoperative pain. The subject was to rest in this position for at least 5 minutes before responding to the following question, On a scale of 0 to 10, where 0=no pain and 10=worst possible pain, how much pain are you having right now?" (NCT00744848)
Timeframe: through 96 hours
Intervention | Units on a scale*hours (Mean) |
---|
Bupivacaine HCl | 359 |
SKY0402 | 396 |
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Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) With Activity (NRS-A) Pain Intensity Scores
"Assessments of postoperative pain included pain intensity at rest (using the NRS at rest [NRS-R] and with activity [using the NRS-A]) where the prescribed activity was raising both arms.~Pain intensity was assessed on a scale of 0 to 10, where 0=no pain and 10=worst possible pain." (NCT00813111)
Timeframe: through 72 hours
Intervention | Units on a scale*hours (Mean) |
---|
SKY0402 | 441 |
Bupivacaine HCl | 467 |
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Reduction in the Number and Timing of Anaphylactic Events in Subjects With a History of Frequent Idiopathic Anaphylaxis.
To determine if treatment with omalizumab over 6 months will produce a reduction in the number and timing of anaphylactic events in subjects with a history of frequent idiopathic anaphylaxis. Ordinal outcome of participants based on number of events in 6 months after baseline and timing of first event. Events were calculated based on detailed event logs maintained by the patients and collected every 2-4 weeks based on injection schedule. Mean percent change in number of events experienced while on study agent for each subject and results presented as a group. (NCT00890162)
Timeframe: 6 months
Intervention | percentage of change of events (Mean) |
---|
Omalizumab | 32 |
Placebo | 6 |
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Number of Patients Needing Rescue Medication
Number of patients who required rescue medication within 6 hours (NCT00895843)
Timeframe: At 6 hours
Intervention | Participants (Number) |
---|
Conventional Ibuprofen | 32 |
Brufen Retard | 29 |
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Pain( Visual Analog Scale )
An independent investigator who was blinded to randomization assessed pain level using 0 to 10 visual analog scale (VAS) that ranged from 0 (no pain) to 10 (worst imaginable pain)at the night after operation. (NCT00901628)
Timeframe: the night after surgery
Intervention | units on a scale (Mean) |
---|
Periarticular Injection Group | 2.3 |
No Injection Group | 6.4 |
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Maximal Flexion Angle Degree on Postoperative 7 Day
An independent investigator measured the maximal flexion angle (degree) of replaced knee with 28 centimeter armed goniometer on postoperative 7 day (NCT00901628)
Timeframe: postoperative 7 day
Intervention | degree (Mean) |
---|
Periarticular Injection Group | 92.3 |
No Injection Group | 95.2 |
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Intravenous Patient Controlled Analgesia(PCA) Consumption During 24 Hours After Surgery
Fentanyl based PCA consumption via PCA pump (microgram) (NCT00901628)
Timeframe: 24 hours postoperative
Intervention | microgram (Mean) |
---|
Periarticular Injection Group | 169.4 |
No Injection Group | 262.3 |
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the Proportion of Patients Who Were Satisfied With the Pain Management
(NCT00901628)
Timeframe: postoperative 7 day
Intervention | participants (Number) |
---|
Periarticular Injection Group | 38 |
No Injection Group | 39 |
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The Proportion of Patients Who Could Raise Leg With Replaced Knee Extended
(NCT00901628)
Timeframe: 24 hours postoperative
Intervention | participants (Number) |
---|
Periarticular Injection Group | 18 |
No Injection Group | 6 |
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Participant Number of Postoperative Nausea and Vomiting During 24 Hours After Surgery
An independent investigator assessed participant number of postoperative nausea and vomiting during 24 hours after surgery. Nausea was defined as a subjective unpleasant sensation associated with awareness of the urge to vomit; and vomiting, as the forceful expulsion of gastric contents from the mouth. (NCT00901628)
Timeframe: 24 hours after surgery
Intervention | participants (Number) |
---|
Periarticular Injection Group | 22 |
No Injection Group | 15 |
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Narcotic Consumption During Hospitalization
A variety of pain medications were used after surgery to keep patients comfortable. Narcotic use was recorded as morphine equivalents. We report the mean narcotic consumption for each group for the day of surgery as well as post operative day 1,2, and 3. (NCT01042093)
Timeframe: 4 days
Intervention | mg (Mean) |
---|
| Morphine Equivalent Day of Surgery | Morphine Equivalent Post Operative Day 1 | Morphine Equivalent Post Operative Day 2 | Morphine Equivalent Post Operative Day 3 |
---|
ROP/EPI | 52.50 | 51.08 | 36.76 | 15.54 |
,ROP/EPI/CLO | 55.20 | 64.61 | 50.07 | 21.97 |
,ROP/EPI/TOR | 43.09 | 47.95 | 42.69 | 18.72 |
,ROP/EPI/TOR/CLO | 46.92 | 46.54 | 40.71 | 20.45 |
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Numerical Rating Scale (NRS) Pain Scores During Hospitalization.
Patient pain was assessed during hospitalization using the VAS Pain Scale, a numerical rating scale ranging from 0 (no pain) to 10 (severe pain). A lower score represents a better outcome. Pain was assessed preoperatively, 1 hour postoperatively in the post anesthesia unit, and then every 8 hours on the Orthopedic inpatient unit, for a duration of 2 days. (NCT01042093)
Timeframe: 2 days after surgery
Intervention | scores on a scale 0-10 (Mean) |
---|
| Vas Pain Scale - 1 Hour Post Op | Vas Pain Scale - 8 Hour Post Op | Vas Pain Scale - 16 Hour Post Op | Vas Pain Scale - 24 Hour Post Op | Vas Pain Scale - 32 Hour Post Op | Vas Pain Scale - 40 Hour Post Op | Vas Pain Scale - 48 Hour Post Op | Vas Pain Scale Preoperatively |
---|
ROP/EPI | 1.60 | 2.82 | 2.41 | 2.96 | 3.13 | 2.80 | 2.11 | 2.13 |
,ROP/EPI/CLO | 2.67 | 3.93 | 2.75 | 3.63 | 3.62 | 3.28 | 2.56 | 2.43 |
,ROP/EPI/TOR | 1.90 | 1.52 | 2.22 | 2.56 | 2.66 | 2.35 | 1.97 | 2.47 |
,ROP/EPI/TOR/CLO | 1.06 | 1.52 | 1.85 | 2.33 | 2.18 | 2.54 | 2.41 | 1.93 |
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Knee Society Pain Scores at 6 Week Follow-up Appointment
Patients were assessed for pain at their 6 week follow-up appointment using the Knee Society Rating Scale. Using this scale patients are given a pain score ranging from 0 (severe pain) to 50 (No Pain). This is determined as follows: No pain/50 points, Mild or occasional pain/45 points, pain with stairs only/40 points, pain with walking and stairs/30 points, Moderate/occasional pain/ 20 points,continual pain/10 points, severe pain/0 points. We report the mean score for each group. A higher score represents a better outcome. (NCT01042093)
Timeframe: 6 weeks after surgery
Intervention | Scores on a scale 0-50 (Mean) |
---|
ROP/EPI/TOR/CLO | 45 |
REP/EPI/TOR | 43 |
REP/EPI/CLO | 45 |
REP/EPI | 45 |
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Occurrence of Postreperfusion Syndrome (PRS)
the number of patients who showed PRS (hypotension defined as < 30% of baseline mean arterial pressure [MAP] lasting over 1 min immediately after reperfusion of liver graft) was divided by the total number of patients enrolled for each group (NCT01080625)
Timeframe: immediately after reperfusion
Intervention | percentage of participants (Number) |
---|
Phenylephrine | 45 |
Epinephrine | 39 |
Control | 87 |
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Vital Signs: Systolic Blood Pressure (SBP)
Subject vital signs, i.e., blood pressure and heart rate, were measured prior to study drug dosing (baseline) and up to 360 minutes after dosing during the study visit. (NCT01143051)
Timeframe: Pre-dose (baseline) to 360 minutes post-dose
Intervention | mmHg (Mean) |
---|
| Pre-dose (Baseline) | 10 min post-dose | 30 min post-dose | 60 min post-dose | 120 min post-dose | 180 min post-dose | 360 min post-dose |
---|
Treatment C | 111 | 121 | 116 | 115 | 114 | 115 | 113 |
,Treatment T1 | 110 | 123 | 116 | 113 | 112 | 114 | 113 |
,Treatment T2 | 112 | 122 | 117 | 113 | 114 | 113 | 113 |
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Vital Signs: Heart Rate (HR)
Subject vital signs, i.e., blood pressure and heart rate, were measured prior to study drug dosing (baseline) and up to 360 minutes after dosing during the study visit. (NCT01143051)
Timeframe: Pre-dose (baseline) to 360 minutes post-dose
Intervention | beats per minute (Mean) |
---|
| Pre-dose (Baseline) | 10 min post-dose | 30 min post-dose | 60 min post-dose | 120 min post-dose | 180 min post-dose | 360 min post-dose |
---|
Treatment C | 58 | 62 | 61 | 61 | 58 | 63 | 61 |
,Treatment T1 | 60 | 67 | 63 | 67 | 60 | 66 | 64 |
,Treatment T2 | 62 | 69 | 64 | 67 | 60 | 66 | 64 |
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Concentration vs. Time for Total Epinephrine From Time Zero to 6 Hours Post-dose
Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 5, 15, 30, 45, 60, 90, 120, 180, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method. (NCT01143051)
Timeframe: Pre-dose to 6 hours post-dose
Intervention | pg/mL (Mean) |
---|
| Total Epinephrine, 0 min (Baseline) | Total Epinephrine, 5 min post-dose | Total Epinephrine, 15 min post-dose | Total Epinephrine, 30 min post-dose | Total Epinephrine, 45 min post-dose | Total Epinephrine, 60 min post-dose | Total Epinephrine, 90 min post-dose | Total Epinephrine, 120 min post-dose | Total Epinephrine, 180 min post-dose | Total Epinephrine, 240 min post-dose | Total Epinephrine, 360 min post-dose |
---|
Treatment C | 7.8 | 130.2 | 38.5 | 16.8 | 20.9 | 18.0 | 16.7 | 13.1 | 8.4 | 9.8 | 38.3 |
,Treatment T1 | 9.3 | 339.6 | 48.9 | 12.7 | 8.6 | 7.6 | 5.7 | 8.7 | 12.0 | 12.9 | 31.1 |
,Treatment T2 | 8.9 | 442.4 | 62.4 | 17.4 | 13.0 | 14.5 | 13.7 | 15.5 | 10.4 | 11.5 | 29.4 |
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Time to Reach Peak Concentration (Tmax) for Total Epinephrine
Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 5, 15, 30, 45, 60, 90, 120, 180, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method. tmax is the amount of time it takes for epinephrine to reach peak concentration in plasma during the treatment period. (NCT01143051)
Timeframe: Pre-dose to 6 hours post-dose
Intervention | min (Mean) |
---|
Treatment T1 | 34.6 |
Treatment T2 | 37.0 |
Treatment C | 38.0 |
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Peak Concentration (Cmax) for Total Epinephrine From Time Zero to 6 Hours Post-dose
Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 5, 15, 30, 45, 60, 90, 120, 180, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method. Peak (maximum) concentration (Cmax) is the highest concentration of epinephrine measured in plasma during the treatment period. (NCT01143051)
Timeframe: Pre-dose to 6 hours post-dose
Intervention | pg/mL (Mean) |
---|
Treatment T1 | 340 |
Treatment T2 | 444 |
Treatment C | 139 |
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Number of Subjects With Significant Changes in Physical Examination
Physical examinations were performed as a part of Screening and End-of-Study (EOS) procedures. This outcome is a count of the number of subjects that showed a clinically significant change in the EOS physical examination compared to the Screening Visit. (NCT01143051)
Timeframe: Approximately 6 weeks
Intervention | Participants (Count of Participants) |
---|
Randomized Subjects | 0 |
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Serum Potassium Levels
Blood samples used to measure subject serum glucose and potassium levels were collected prior to study drug dosing (baseline) and up to 360 minutes post-dose. (NCT01143051)
Timeframe: Pre-dose (baseline) to 360 minutes post-dose
Intervention | mmol/L (Mean) |
---|
| Pre-dose (Baseline) | 15 min post-dose | 30 min post-dose | 60 min post-dose | 120 min post-dose | 360 min post-dose |
---|
Treatment C | 4 | 4 | 4 | 4 | 4 | 4 |
,Treatment T1 | 4 | 4 | 4 | 4 | 4 | 4 |
,Treatment T2 | 4 | 4 | 4 | 4 | 4 | 4 |
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Vital Signs: Diastolic Blood Pressure (DBP)
Subject vital signs, i.e., blood pressure and heart rate, were measured prior to study drug dosing (baseline) and up to 360 minutes after dosing during the study visit. (NCT01143051)
Timeframe: Pre-dose (baseline) to 360 minutes post-dose
Intervention | mmHg (Mean) |
---|
| Pre-dose (Baseline) | 10 min post-dose | 30 min post-dose | 60 min post-dose | 120 min post-dose | 180 min post-dose | 360 min post-dose |
---|
Treatment C | 61 | 65 | 65 | 63 | 62 | 59 | 62 |
,Treatment T1 | 62 | 63 | 64 | 63 | 61 | 62 | 62 |
,Treatment T2 | 61 | 64 | 64 | 64 | 63 | 60 | 62 |
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Hand Tremor Scores
Subjects evaluated hand tremor experiences using a scale from 0 to 3 (0: No tremor; 1: Mild, perceivable; 2: Moderate, observable; and 3: Severe, interfering with hand activities). Hand tremors were evaluated prior to study drug dosing (baseline) and up to 360 minutes post-dose. (NCT01143051)
Timeframe: Pre-dose (baseline) to 360 minutes post-dose
Intervention | score on a scale (Mean) |
---|
| Pre-dose (Baseline) | 10 min post-dose | 60 min post-dose | 360 min post-dose |
---|
Treatment C | 0.0 | 0.1 | 0.0 | 0.0 |
,Treatment T1 | 0.0 | 0.1 | 0.0 | 0.0 |
,Treatment T2 | 0.0 | 0.2 | 0.0 | 0.0 |
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Serum Glucose Levels
Blood samples used to measure subject serum glucose and potassium levels were collected prior to study drug dosing (baseline) and up to 360 minutes post-dose. (NCT01143051)
Timeframe: Pre-dose (baseline) to 360 minutes post-dose
Intervention | mg/dL (Mean) |
---|
| Pre-dose (Baseline) | 15 min post-dose | 30 min post-dose | 60 min post-dose | 120 min post-dose | 360 min post-dose |
---|
Treatment C | 84 | 96 | 98 | 94 | 83 | 80 |
,Treatment T1 | 83 | 101 | 94 | 86 | 81 | 82 |
,Treatment T2 | 83 | 105 | 99 | 86 | 82 | 82 |
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Area Under the Curve From Time Zero to 6 Hours Post-dose (AUC[0-6])
Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 5, 15, 30, 45, 60, 90, 120, 180, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method. Area under the curve from time zero to 6 hours post-dose (AUC[0-6]) was calculated using the trapezoidal rule. (NCT01143051)
Timeframe: Pre-dose to 6 hours post-dose
Intervention | pg*min/mL (Mean) |
---|
Treatment T1 | 7938 |
Treatment T2 | 9438 |
Treatment C | 7218 |
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Baseline Concentration (C0) of Labeled Epinephrine Total Epinephrine
Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at Baseline (prior to dosing) in each treatment period following a specified washout period (3-14 days), and were analyzed using an established analysis method. Baseline concentration (C0) is the concentration of epinephrine measured in the plasma at this time point. (NCT01143051)
Timeframe: 0 to 30 minutes prior to dosing
Intervention | pg/mL (Mean) |
---|
Treatment T1 | 9.3 |
Treatment T2 | 8.9 |
Treatment C | 7.8 |
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Half-life (t1/2) for Total Epinephrine
Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 5, 15, 30, 45, 60, 90, 120, 180, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method. Half-life (t1/2) is the amount of time it takes for epinephrine decrease to half the peak concentration in plasma during the treatment period. (NCT01143051)
Timeframe: Pre-dose to 6 hours post-dose
Intervention | min (Mean) |
---|
Treatment T1 | 125.9 |
Treatment T2 | 158.8 |
Treatment C | 237.3 |
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ECG: QT Interval
Subject QT and QTc Intervals were recorded using a 12-Lead ECG prior to study drug dosing (baseline) and up to 360 minutes after dosing during the study visit. (NCT01143051)
Timeframe: Pre-dose (baseline) to 360 minutes post-dose
Intervention | msec (Mean) |
---|
| Pre-dose (Baseline) | 30 min post-dose | 90 min post-dose | 360 min post-dose |
---|
Treatment C | 423 | 413 | 407 | 400 |
,Treatment T1 | 416 | 404 | 399 | 399 |
,Treatment T2 | 407 | 405 | 401 | 400 |
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ECG: QTc Interval
Subject QT and QTc Intervals were recorded using a 12-Lead ECG prior to study drug dosing (baseline) and up to 360 minutes after dosing during the study visit. (NCT01143051)
Timeframe: Pre-dose (baseline) to 360 minutes post-dose
Intervention | msec (Mean) |
---|
| Pre-dose (Baseline) | 30 min post-dose | 90 min post-dose | 360 min post-dose |
---|
Treatment C | 403 | 412 | 403 | 402 |
,Treatment T1 | 407 | 408 | 401 | 403 |
,Treatment T2 | 407 | 411 | 401 | 403 |
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Number of Subjects With Significant Changes in Laboratory Tests
Laboratory tests (CBC, serum comprehensive metabolic panel, urinalysis, and urinary pregnancy test for women of childbearing potential) were performed as a part of Screening and End-of-Study (EOS) procedures. This outcome is a count of the number of subjects that showed a clinically significant change in the EOS laboratory tests compared to the Screening Visit. (NCT01143051)
Timeframe: Approximately 6 weeks
Intervention | Participants (Count of Participants) |
---|
Randomized Subjects | 0 |
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Baseline Concentration (C0) of Total Epinephrine
Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at Baseline (prior to dosing) in each treatment period following a specified washout period (3-14 days), and were analyzed using an established analysis method. Baseline concentration (C0) is the concentration of epinephrine measured in the plasma at this time point. (NCT01188577)
Timeframe: 0 to 30 minutes prior to dosing
Intervention | pg/mL (Mean) |
---|
Treatment T | 2.6 |
Treatment C | 4.3 |
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Half-life (t1/2) of Total Epinephrine
Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 2, 5, 7.5, 10, 12.5, 15, 20, 25, 30, 45, 60, 90, 120, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method. Half-life (t1/2) is the amount of time it takes for epinephrine to decrease to half the peak concentration in plasma during the treatment period. (NCT01188577)
Timeframe: Pre-dose to 6 hours post-dose
Intervention | min (Mean) |
---|
Treatment T | 145.9 |
Treatment C | 289.8 |
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Peak Concentration (Cmax) of Total Epinephrine From Time Zero to 6 Hours Post-dose
Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 2, 5, 7.5, 10, 12.5, 15, 20, 25, 30, 45, 60, 90, 120, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method. Peak (maximum) concentration (Cmax) is the highest concentration of epinephrine measured in plasma during the treatment period. (NCT01188577)
Timeframe: Pre-dose to 6 hours post-dose
Intervention | pg/mL (Mean) |
---|
Treatment T | 862 |
Treatment C | 190 |
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Time to Reach Peak Concentration (Tmax) for Total Epinephrine
Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 2, 5, 7.5, 10, 12.5, 15, 20, 25, 30, 45, 60, 90, 120, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method. Tmax is the amount of time it takes for epinephrine to reach peak concentration in plasma during the treatment period. (NCT01188577)
Timeframe: Pre-dose to 6 hours post-dose
Intervention | min (Mean) |
---|
Treatment T | 2.3 |
Treatment C | 3.4 |
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Area Under the Curve From Time Zero to 6 Hours Post-dose (AUC[0-6]) for Total Epinephrine
Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 2, 5, 7.5, 10, 12.5, 15, 20, 25, 30, 45, 60, 90, 120, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method. Area under the curve from time zero to 6 hours post-dose (AUC[0-6]) was calculated using the trapezoidal rule. (NCT01188577)
Timeframe: Pre-dose to 6 hours post-dose
Intervention | pg*min/mL (Mean) |
---|
Treatment T | 8498 |
Treatment C | 6191 |
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Concentration vs. Time for Total Epinephrine From Time Zero to 6 Hours Post-dose
Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 2, 5, 7.5, 10, 12.5, 15, 20, 25, 30, 45, 60, 90, 120, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method. (NCT01188577)
Timeframe: Pre-dose to 6 hours post-dose
Intervention | pg/mL (Mean) |
---|
| 0 min (Baseline) | 2 min post-dose | 5 min post-dose | 7.5 min post-dose | 10 min post-dose | 12.5 min post-dose | 15 min post-dose | 20 min post-dose | 25 min post-dose | 30 min post-dose | 45 min post-dose | 60 min post-dose | 90 min post-dose | 120 min post-dose | 240 min post-dose | 360 min post-dose |
---|
Treatment C | 4.3 | 189.0 | 99.1 | 48.8 | 39.7 | 33.9 | 32.0 | 30.1 | 20.3 | 17.7 | 19.8 | 13.2 | 11.2 | 6.9 | 17.7 | 17.2 |
,Treatment T | 2.6 | 861.5 | 379.4 | 186.6 | 118.3 | 75.6 | 46.8 | 22.9 | 10.9 | 10.5 | 10.5 | 8.7 | 3.5 | 6.5 | 16.1 | 17.1 |
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Length of Action
The time from onset of local anesthesia until cessation of effect by sensation of sharp measured in 15 minute increments. (NCT01243112)
Timeframe: Up to 12 hours
Intervention | minutes (Mean) |
---|
| 1% Lidocaine With Epinephrine | 0.25% Bupivacaine With Epinephrine | 0.5% Lidocaine and 0.125% Bupivacaine With Epineph | 1% Lidocaine and 0.25% Bupivacaine With Epinephrin |
---|
Study Group | 6.63 | 7.02 | 7.48 | 7.16 |
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Onset of Action
Time from infusion of local anesthetic to loss of sensation to sharp. (NCT01243112)
Timeframe: Up to 5 minutes
Intervention | second (Mean) |
---|
| 1% Lidocaine With Epinephrine | 0.25% Bupivacaine With Epinephrine | 0.5% Lidocaine and 0.125% Bupivacaine With Epineph | 1% Lidocaine and 0.25% Bupivacaine With Epinephrin |
---|
Study Group | 29 | 19 | 26 | 12 |
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Mean Change in Clinical Severity Score
"Mean changes in the Clinical Severity Score after 2 sessions of nebulisation as compared to baseline.~Clinical Severity Score devised by Wang et al, is an objective scoring system that measures the degree of respiratory distress in young children.~The scoring system assesses respiratory rate, wheezing, retraction, and general condition,scores ranging from 0 to 3, with higher scores indicating severe illness and vice versa.~The total scores range from 0 to 12, with increased severity receiving a higher score (Wang et al, 1992).~This scoring systems have previously been validated in a number of well designed randomized controlled trials(Anil 2010, Kuzik 2007, Sarrell 2002, and Mandelberg 2003). A 1 point improvement in the clinical severity score implies approximately 7% betterment of symptoms on the scale." (NCT01276821)
Timeframe: 2 hours
Intervention | units on a scale (Mean) |
---|
Standard | 2.26 |
Study | 3.57 |
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Relapse Rate
To study the number of patients in either group who need another unscheduled medical visit within the initial 24 hours of ER/ OPD visit (NCT01276821)
Timeframe: 24 hours
Intervention | Participants (Number) |
---|
| Hospital Re-visit within 24 hours | No Hospital Re-visit within 24 hours |
---|
Standard | 15 | 35 |
,Study | 5 | 45 |
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Persistence of Cough at the End of 1 Week
Number of patients in each intervention group whose parents reported the persistence of initial cough at the end of 1 week in their children. (NCT01276821)
Timeframe: 7 days
Intervention | participants (Number) |
---|
| Persistence of cough at the end of 1 week | Absence of cough at the end of 1 week |
---|
Standard | 37 | 13 |
,Study | 31 | 19 |
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Need for Unscheduled Medical Visits, if Any, for Same Symptoms to Any Healthcare Facility Within 1 Week
(NCT01276821)
Timeframe: 7 days
Intervention | participants (Number) |
---|
| Unscheduled medical Visits in 1 week | No Unscheduled medical visits in 1 week |
---|
Standard | 23 | 27 |
,Study | 18 | 32 |
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Missed Days of Work of Caregivers
Number of patients in each intervention group whose parents reported at least 1 day of missed work due to the illness of child within the week following the initial hospital visit on 7 day follow-up call. (NCT01276821)
Timeframe: 7 days
Intervention | participants (Number) |
---|
Standard | 10 |
Study | 3 |
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Average Duration of Crying (in Minutes) Among Babies Receiving Nebulisation Therapy.
The outcomes tries to compare the influence of duration of crying among babies receiving nebulization which interferes with drug delivery and henceforth might create a confounding bias while interpreting results. (NCT01276821)
Timeframe: 2 hours
Intervention | Minutes (Mean) |
---|
Standard | 2.16 |
Study | 2.03 |
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Patients Meeting Eligibility Criteria for ER/ OPD Discharge at the End of 2 Hours of Observation
(NCT01276821)
Timeframe: At the end of 2 hours
Intervention | participants (Number) |
---|
| Meets Criteria for ER/OPD discharge after 120 mins | Does not meet criteria for ER/OPD discharge |
---|
Standard | 15 | 35 |
,Study | 35 | 15 |
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Opioid Requirements Postoperative
Supplementary opioid requirements for the first 48 hours from arriving in the post anesthesia care unit. Results are total opioid-requirements for the first 48 hours. Way of administration was intravenous in all but 6 administrations. If given orally, a 1:3 ratio was used for conversion from oral to intravenous morphine. (NCT01395043)
Timeframe: 48 hours from arriving in the post anesthesia care unit.
Intervention | mg iv morphin equivalent (Mean) |
---|
Bilateral Ultrasoundguide TAP-catheter | 35 |
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Postoperative Pain Using Numerical Rating Scale (NRS) 0-10
"NRS is a pain score and the score can vary between 0 and 10 by which 0 means no pain and 10 equals the worst possible pain.~NRS was evaluated at the time 0, 1, 2, 4, 8 , 12, 18 , 24 and 36 hours after arriving in the post anesthesia care unit at rest and during coughing." (NCT01395043)
Timeframe: 0-36 hours postoperative
Intervention | Units on Numerical Rating Score (Median) |
---|
| NRS at rest, all times | Overall NRS when coughing, all times |
---|
Bilateral Ultrasoundguide TAP-catheter | 3 | 5 |
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Time to Peak Methemoglobin Blood Levels
The length of time between the administration of local anesthetic (Prilocaine and Lidocaine Groups) or start of restorative dental procedures (No local anesthetic Group) and the time at which the maximum methemoglobin blood level is observed. (NCT01402869)
Timeframe: Measured at 10 second intervals during dental treatment for an average of 2 hours
Intervention | minutes (Mean) |
---|
Prilocaine | 62.73 |
Lidocaine | 57.50 |
No Local Anesthetic | 29.50 |
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Peak Methemoglobin Blood Levels
The maximum percentage of methemoglobin in blood (NCT01402869)
Timeframe: Measured at 10 second intervals during dental treatment for an average of 2 hours
Intervention | percentage of methemoglobin in blood (Mean) |
---|
Prilocaine | 3.55 |
Lidocaine | 1.63 |
No Local Anesthetic | 1.60 |
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Delta Methemoglobin Blood Level
Change in percentage of methemoglobin in blood from baseline level to peak level (NCT01402869)
Timeframe: From administration of local anesthetic or start of restorative procedures to time at which maximum methemoglobin blood level was documented during dental treatment for an average of 2 hours
Intervention | percentage of methemoglobin in blood (Mean) |
---|
Prilocaine | 2.73 |
Lidocaine | 0.78 |
No Local Anesthetic | 0.76 |
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Intraoperative Time
The total time in the operating room will be recorded to see if there is a difference between groups. (NCT01479270)
Timeframe: the total intraoperative time in minutes
Intervention | Minutes (Median) |
---|
TAP Block | 47.4 |
No Block | 34.5 |
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Narcotic Use
narcotic use in mg of Morphine will be recorded (NCT01479270)
Timeframe: Postop Day #0 and Day #1
Intervention | mg of morphine (Median) |
---|
| Post operative day #0 | Post operative day #1 |
---|
No Block | 11.8 | 9.0 |
,Tap Block | 11.7 | 7.5 |
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Visual Analog Scale (VAS) for Pain
visual analogue scales for pain will be completed on post-operative day #0 and #1, pain is assessed on a 10-point visual analogue scale (0 = no pain; 1 to 3 = mild; 4 to 6 = moderate pain; 7 to 10 = severe pain.) (NCT01479270)
Timeframe: 2 and 24 hours post operative
Intervention | units on a scale (Median) |
---|
| 2 hours post operative | 24 hours post operative |
---|
No Block | 6.0 | 5.0 |
,Tap Block | 5.0 | 5.0 |
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Quality of Recovery Questionnaire (QoR-40) on Postop Day #1 or #2
40 question survey completed on paper or by telephone on post-operative day #1 or #2, designed to measure health status after surgery and anesthesia. Scale ranges from 40 (extremely poor qualify of recovery) to 200 (excellent quality of recovery). (NCT01479270)
Timeframe: Postop Day #1 or Day #2
Intervention | units on a scale (Median) |
---|
TAP Block | 168.0 |
No Block | 169.5 |
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Number of Subjects Who Passed the Voiding Trial After a Midurethral Sling
Study team assessment of whether the use of local anesthetic has any affect on the percentage of patients who pass their post-operative bladder challenge. This is determined by their voided volume and post-void residual. (NCT01583166)
Timeframe: 2 weeks
Intervention | Participants (Count of Participants) |
---|
Marcaine + Epinephrine | 31 |
Saline + Epinephrine | 32 |
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Post-operative Pain Scale at 6-7 Hours Post op
Visual analog score at 6 hours post op will be compared in the two groups. The scale ranges from 0 (no pain) to a maximum of 10 (unbearable pain) (NCT01583166)
Timeframe: 6-7 hours
Intervention | units on a scale (Mean) |
---|
Marcaine + Epinephrine | 3.1 |
Saline + Epinephrine | 4.1 |
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Post-operative Pain Scores at 2-3 Hours Post op
Visual analog score at 2 hours post op will be compared in the two groups. The scale ranges from 0 (no pain) to a maximum of 10 (unbearable pain) (NCT01583166)
Timeframe: 2-3 hours
Intervention | units on a scale (Mean) |
---|
Marcaine + Epinephrine | 3 |
Saline + Epinephrine | 2.9 |
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Visual Analog Scale for Pain: Pre-operative.
Participants asked to report on pre-operative level of pain using a Visual Analog Scale. The scale is participant reported and ranges from 0 representing no pain to 10 representing unbearable pain. (NCT01583166)
Timeframe: At enrollment
Intervention | Reported Pain Level score on VAS (Mean) |
---|
Marcaine + Epinephrine | 0.0 |
Saline + Epinephrine | 0.0 |
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Anti-emetic / Intraoperative Medication Administered (mg)
The secondary outcomes that will be measured in this study include the amount of anti-emetic medication used in the first 24 hours post-op. This data will be attained by reviewing the medical record and through the validated survey questions. (NCT01602692)
Timeframe: Up to 24 hours following surgery
Intervention | mg (Mean) |
---|
| Mean Intraoperative hydromorphone | Mean Intraoperative midazolam | Mean Intraoperative ketorolac | Mean Intraoperative dexamethasone | Mean Intraoperative ondansetron |
---|
Tumescent Solution With Dilute Epinephrine | 0.98 | 2.00 | 11.25 | 6.40 | 3.60 |
,Tumescent Solution With Dilute Lidocaine and Epinephrine | 1.06 | 1.90 | 16.50 | 6.00 | 4.05 |
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Amount of Post-Operative Narcotic Medication Administered
Aim 1 is to determine the effect of dilute lidocaine in tumescent solution on post-operative pain following breast reduction surgery. The amount of narcotic medication administered (in Postanesthesia Care Unit (PACU), phase 2 and up to 24 hours post-op) determined by reviewing the medical record. (NCT01602692)
Timeframe: Up to 24 hours following surgery
Intervention | mg (Mean) |
---|
| PACU IV hydromorphone | First 24 hr Post-op oxycodone |
---|
Tumescent Solution With Dilute Epinephrine | 0.89 | 32.19 |
,Tumescent Solution With Dilute Lidocaine and Epinephrine | 0.55 | 29.47 |
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Unplanned Hospital Readmission
The patient's medical record will be reviewed to see if the patient was readmitted to the hospital (unplanned) due to complications related to this surgery. (NCT01602692)
Timeframe: Up to 1 week following surgery
Intervention | Participants (Count of Participants) |
---|
Tumescent Solution With Dilute Epinephrine | 0 |
Tumescent Solution With Dilute Lidocaine and Epinephrine | 0 |
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Time to Discharge
The patient's medical record will be reviewed to determine the time it took for the patient to be transitioned from the PACU (post anesthesia care unit) till discharge. This includes the time spent in the PACU, time spent in phase 2 and the total time to discharge. (NCT01602692)
Timeframe: Up to 24 hours following surgery
Intervention | minutes (Mean) |
---|
Tumescent Solution With Dilute Epinephrine | 158 |
Tumescent Solution With Dilute Lidocaine and Epinephrine | 153 |
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Anti-emetic / Intraoperative Fentanyl Administered (Measured in Micrograms)
The secondary outcomes that will be measured in this study include the amount of anti-emetic medication used in the first 24 hours post-op. This data will be attained by reviewing the medical record and through the validated survey questions. (NCT01602692)
Timeframe: Up to 24 hours following surgery
Intervention | micrograms (Mean) |
---|
Tumescent Solution With Dilute Epinephrine | 131.30 |
Tumescent Solution With Dilute Lidocaine and Epinephrine | 120.00 |
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Post-operative Pain
Aim 1 is to determine the effect of dilute lidocaine in tumescent solution on post-operative pain following breast reduction surgery. The data points that will be statistically compared will be pain scores determined via a validated pain survey (pain levels on a scale of 0-10 where 10 is the worst pain) and the amount of narcotic medication administered (in Postanesthesia Care Unit (PACU), phase 2 and up to 24 hours post-op) determined from responses to survey questions and by reviewing the medical record. (NCT01602692)
Timeframe: Up to 24 hours following surgery
Intervention | score on a scale (Mean) |
---|
| End of PACU Mean Pain Level | First 24 hrs Post-op Mean Current Pain | First 24 hrs Post-op Mean Worst Pain | First 24 hrs Post-op Mean Least Pain |
---|
Tumescent Solution With Dilute Epinephrine | 5.47 | 4.00 | 6.44 | 2.00 |
,Tumescent Solution With Dilute Lidocaine and Epinephrine | 4.47 | 4.28 | 6.68 | 2.53 |
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Post Operative Nausea and Vomiting
The secondary outcomes that will be measured in this study include number of episodes of post-operative nausea (subjective feeling vs. emesis). This data will be attained by reviewing the medical record and through the validated survey questions. (NCT01602692)
Timeframe: Up to 24 hours following surgery
Intervention | episodes (Number) |
---|
| Nausea | Vomiting |
---|
Tumescent Solution With Dilute Epinephrine | 8 | 2 |
,Tumescent Solution With Dilute Lidocaine and Epinephrine | 10 | 4 |
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Participant Pain Experience After Administration of Local Anesthesia to Numb the Gums and Teeth During Dental Treatment
"Two treatment visits were required for bilateral, mandibular dental operative restorations. At each visit, local anesthetic was delivered to the right or left side of the dentition using one of the two anesthetic types. The administering operator stepped out of the room after each injection was completed, and the participant was asked by a trained research assistant to record a visual analog scale (VAS) pain score. The VAS was used to assess pain sensitivity, and utilizes a 100mm horizontal line, with scores ranging from 0 (no pain) to 100 (pain as bad as it can be)." (NCT01622296)
Timeframe: immediately after anesthetic injection
Intervention | units on a scale (Mean) |
---|
| Pain on inferior alveolar nerve block | Pain on long buccal nerve block |
---|
Buffered Lidocaine | 33.1 | 9.8 |
,Lidocaine | 43 | 7.3 |
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Number of Participants Who Discontinue Study Drug Due to an AE
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. (NCT01700192)
Timeframe: Up to 52 weeks
Intervention | Participants (Number) |
---|
MK-8237 | 73 |
Placebo | 19 |
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Average Total Combined Rhinoconjunctivitis Score (TCS) During Last 8 Weeks of Treatment
The TCS is the sum of the rhinoconjunctivitis DSS (rhinitis DSS and conjunctivitis DSS; range: 0 to 18) and the rhinoconjunctivitis DMS (rhinitis DMS and conjunctivitis DMS; range: 0 to 20); the total possible TCS ranges from 0 to 38 points with higher scores indicative of greater symptom severity. The endpoint was calculated as the average daily diary entry score from the last 8 weeks of treatment. (NCT01700192)
Timeframe: Last 8 weeks of treatment (Weeks 44 to 52)
Intervention | Score on a Scale (Mean) |
---|
MK-8237 | 6.40 |
Placebo | 7.62 |
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Average Total Combined Rhinitis Score (TCRS) During Last 8 Weeks of Treatment
The TCRS is the sum of the rhinitis Daily Symptom Score (DSS; range: 0 to 12) and the rhinitis Daily Medication Score (DMS; range: 0 to 12); the total possible TCRS ranges from 0 to 24 points with higher scores indicative of greater symptom severity. The endpoint was calculated as the average daily diary entry score from the last 8 weeks of treatment. (NCT01700192)
Timeframe: Last 8 weeks of treatment (Weeks 44 to 52)
Intervention | Score on a Scale (Mean) |
---|
MK-8237 | 4.67 |
Placebo | 5.49 |
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Average Rhinitis Daily Symptom Score (Rhinitis DSS) During Last 8 Weeks of Treatment
The Rhinitis DSS ranges from a score of 0 to 12 (higher scores indicative of greater symptom severity). The endpoint was calculated as the average daily diary entry score from the last 8 weeks of treatment. (NCT01700192)
Timeframe: Last 8 weeks of treatment (Weeks 44 to 52)
Intervention | Score on a Scale (Mean) |
---|
MK-8237 | 3.83 |
Placebo | 4.46 |
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Average Rhinitis Daily Medication Score (Rhinitis DMS) During Last 8 Weeks of Treatment
The Rhinitis DMS ranges from a score of 0 to 12 (higher scores indicative of greater symptomatic medication use). The endpoint was calculated as the average daily diary entry score from the last 8 weeks of treatment. (NCT01700192)
Timeframe: Last 8 weeks of treatment (Weeks 44 to 52)
Intervention | Score on a Scale (Mean) |
---|
MK-8237 | 0.84 |
Placebo | 1.03 |
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Average Allergic Rhinitis/Rhinoconjunctivitis Symptoms Assessed by Visual Analogue Scale (VAS) During Last 8 Weeks of Treatment
"Participants indicated the severity of symptoms in the past week on a VAS with a score range of 0 (no symptoms) to 100 (severe symptoms). Symptoms were assessed during 2 clinic visits occurring during the final 8 weeks of treatment (VAS score reflects the mean of 2 scores)." (NCT01700192)
Timeframe: Last 8 weeks of treatment (Weeks 44 to 52)
Intervention | Score on a Scale (Mean) |
---|
MK-8237 | 42.29 |
Placebo | 47.96 |
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Number of Participants Who Experience At Least One Adverse Event (AE)
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. (NCT01700192)
Timeframe: Up to 54 weeks
Intervention | Participants (Number) |
---|
MK-8237 | 676 |
Placebo | 539 |
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Disposition
Disposition from the ED or rates of discharge. (NCT01705964)
Timeframe: At the time a dispostion from the ED is completed (usually within 4 hours of the study intervention)
Intervention | Participants (Count of Participants) |
---|
IM Epinephrine 1:1000 | 15 |
No Intervention | 12 |
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Change in Percent of Predicted PEFR at t120
Change in percent of predicted Peak Expiratory Flow Rate (PEFR) 120 minutes after study intervention compared to baseline (NCT01705964)
Timeframe: 120 minutes after the study intervention
Intervention | percentage of PEFR (Mean) |
---|
IM Epinephrine 1:1000 | 64.51 |
No Intervention | 56.18 |
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Change in Percent of Predicted Peak Expiratory Flow Rate (PEFR) at t15
Change in percent of predicted Peak Expiratory Flow Rate (PEFR) 15 minutes after the study intervention (t15). (NCT01705964)
Timeframe: 15 minutes after the study intervention
Intervention | percentage of predicted (Mean) |
---|
IM Epinephrine 1:1000 | 59.56 |
No Intervention | 52.45 |
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Breaths Per Minute at t120
breaths per minute at t120 minutes compared to baseline (NCT01705964)
Timeframe: breaths per minute 120 minutes after the study intervention
Intervention | breaths per minute (Mean) |
---|
IM Epinephrine 1:1000 | 24.29 |
No Intervention | 29.29 |
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Heart Rate at t120
Heart rate at t120 minutes in beats per minute (BPM) (NCT01705964)
Timeframe: up to 120 minutes after the study intervention
Intervention | Beats per minute (Mean) |
---|
IM Epinephrine 1:1000 | 147.65 |
No Intervention | 142.29 |
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Heart Rate
"The heart rate (heart beats for minutes) will be recorded every 15 minutes, until the surgery is over or until 300 minutes.~The Co-investigator will record this data in a special data sheeet For the secondary objective of Heart rate, we calculated the average within sides treated with cocaine vs adrenaline and assessed its difference" (NCT01706952)
Timeframe: Every 15 minutes until 300 minutes
Intervention | Heart Beats per minute (Mean) |
---|
Cocaine SIDE | 74.68 |
Adrenaline SIDE | 73.62 |
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Blood Pressure
"The mean blood pressure, defined as the average arterial pressure during a single cardiac cycle, will be recorded every 15 minutes, until the surgery is over or until 300 minutes.~For the secondary objective of blood pressure, we calculated the mean within sides treated with cocaine vs adrenaline and assessed its difference" (NCT01706952)
Timeframe: Every 15 minutes or until 300 minutes
Intervention | mmHg (Mean) |
---|
Cocaine SIDE | 68.02 |
Adrenaline SIDE | 68.41 |
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End Tidal CO2
"The concentration of carbon dioxide (CO2) in the respiratory gases will be recorded every 15 minutes or until 300 minutes.~For the secondary objective of concentration of carbon dioxide, we calculated the mean within sides treated with cocaine vs adrenaline and assessed its difference" (NCT01706952)
Timeframe: Every 15 minutes or until 300 minutes
Intervention | Percentage of carbon dioxide (Mean) |
---|
Cocaine SIDE | 32.26 |
Adrenaline SIDE | 31.69 |
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To Estimate the Change in Bleeding Category (Surgical Field Improvement) as Measured on a Six-point Scale, Measured From 0 (Best Case) to 5 (Worst Case).
"0 No bleeding.~Slight bleeding - no suctioning of blood required.~Slight bleeding - occasional suctioning required. Surgical field not threatened.~Slight bleeding - frequent suctioning required. Bleeding threatens surgical field a few seconds after suction is removed.~Moderate bleeding - frequent suctioning required. Bleeding threatens surgical field directly after suction is removed.~Severe bleeding - constant suctioning required. Bleeding appears faster than can be removed by suction. Surgical field severely threatened and surgery not possible.~For the primary objective of surgical field grade, we calculated the mean within sides treated with cocaine vs adrenaline and assessed its difference" (NCT01706952)
Timeframe: Every 15 minutes until 300 minutes
Intervention | units on a scale (Mean) |
---|
Cocaine SIDE | 2.17 |
Adrenaline SIDE | 2.04 |
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Time to First Opioid Dose
Median time between PACU discharge and first opioid dose on the ward. (NCT01759407)
Timeframe: From PACU discharge until first opioid dose on the ward, assessed up to 24 hours
Intervention | hours (Median) |
---|
Femoral Nerve Block | 3.3 |
Standard Anesthetic Management | 3.8 |
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Post-anesthesia Care Unit (PACU) Pain Scores
Hannallah et al developed the Objective Pain Scale (OPS) to monitor pain in children after surgery. Parameters: (1) systolic blood pressure, (2) crying, (3) movement, (4) agitation (confused, excited), (5) complains of pain (may not be possible in younger children). Interpretation: minimum score: 0; maximum score: 10; maximum score if too young to complain of pain: 8; the higher the score, the greater the degree of pain. (NCT01759407)
Timeframe: 30 mins after surgery
Intervention | pain score (Median) |
---|
Femoral Nerve Block | 0 |
Standard Anesthetic Management | 3 |
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Intraoperative End-tidal Isoflurane %
Median end-tidal isoflurane concentration per participant during the average 1 1/2 hr. surgery. (NCT01759407)
Timeframe: 1 1/2 hr.
Intervention | percentage of isoflurane (Median) |
---|
Femoral Nerve Block | 1.1 |
Standard Anesthetic Management | 1.5 |
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MAP While on Vasopressors
The primary feasibility outcome will be the difference in the means of mean arterial pressures (MAP) while on vasopressors and we define acceptable adherence (the threshold for feasibility) by a difference of at least 5 mmHg while on vasopressors (rejecting the null hypothesis of a difference of less than 5 mmHg - see proposed sample size). (NCT01800877)
Timeframe: While on vasopressors from randomization until 28 days
Intervention | mmHg (Mean) |
---|
Liberal Approach | 79 |
Restrictive Approach | 70 |
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Time in Minutes That Tq Remained Inflated
15 minutes after either Bupivacaine or placebo injection, Tq was inflated to 100 mm Hg over subjects systolic blood pressure. When the subject found the Tq too uncomfortable, the Tq was deflated and the time documented. Approximately one month later, each subject had the opposite injection of either placebo or Bupivacaine on the same arm, and the duration of Tq inflation was again measured. Due to a strong crossover effect, only the data assessed from the first intervention was analyzed. (NCT01829399)
Timeframe: Tq was inflated 15 minutes after injection of Bupivacaine or placebo and remained inflated until subject could no longer tolerate it. Maximum allowable inflation time per session was 60 minutes.
Intervention | Minutes (Mean) |
---|
Bupivacaine Axillary Ring on 1st Visit | 30.5 |
Saline Axillary Ring on 1st Visit (Control Group) | 22.4 |
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Pain Score at Time of Tq Deflation
A visual analog pain score (VAS) from 0 to 10 was assessed at the time of Tq deflation. 0 indicating no pain, and 10 indicating the worst possible pain. All participants requested deflation prior to the maximum allowable 60 minutes, Subjects were instructed to request deflation at the same degree of discomfort for each visit. Due to a strong crossover effect, only the data assessed from the first intervention was analyzed. (NCT01829399)
Timeframe: Tq will be deflated upon subject's request. VAS is assessed at time of deflation for degree of discomfort prompting deflation request, up to 60 minutes post intervention.
Intervention | scores on a scale (Mean) |
---|
Bupivacaine Ring 1st Visit | 6.1 |
Saline Axillary Ring on 1st Visit (Control Group) | 5.0 |
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Number of Participants Achieving Pulpal Anesthesia.
An electric pulp tester will be used to test the lower jaw teeth (molars, premolars, and incisors) for anesthesia (numbness) in 4-minute time cycles for 60 minutes. Measurements of less than 80 on the EPT is considered not numb (anesthesia failure). Readings of 80 equate to anesthetic success. (NCT01862614)
Timeframe: 60 minutes per injection sequence.
Intervention | Participants (Count of Participants) |
---|
Articaine | 52 |
Buffered Articaine | 57 |
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Six Minute Walking Test (6MWT)
"The 6MWT assesses endurance and ability to walk over longer distances. The 6MWT was first described as a field test for physical fitness in 1963 and then as a 12-minute walk test in people with chronic bronchitis. The 6MWT was found to perform as well as the 12-minute walk, and is now used to assess the submaximal level of functional performance at a similar level required for daily physical activities.~Used in many conditions, such as osteoarthritis, cardiopulmonary disease, stroke, traumatic brain injury, patients who have undergone an amputation, Parkinson's disease, and Alzheimer's disease, as well as in elderly populations and children." (NCT01966263)
Timeframe: 1 year
Intervention | meters (Mean) |
---|
Local Infiltration Analgesia (LIA) | 489 |
Femoral Nerve Block (FNB) | 505 |
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Stair Climbing Task (SCT)
The SCT assesses the ability to ascend and descend a flight of stairs, as well as lower extremity strength, power, and balance. (NCT01966263)
Timeframe: one year
Intervention | seconds (Mean) |
---|
Local Infiltration Analgesia (LIA) | 14.3 |
Femoral Nerve Block (FNB) | 13.8 |
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Timed Up and Go Test (TUG)
"The TUG assesses basic mobility skill as well as strength, balance, and agility. Originally developed for frail elderly people as the Get-Up and Go Test in 1986, it was adapted in 1991 to include the time component. The TUG is used in a range of populations from children to the elderly and for many conditions, including osteoarthritis, joint arthroplasty, rheumatoid arthritis, hip fractures, stroke, vertigo, and cerebral palsy." (NCT01966263)
Timeframe: 1 year
Intervention | seconds (Mean) |
---|
Local Infiltration Analgesia (LIA) | 7.8 |
Femoral Nerve Block (FNB) | 7.6 |
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Pain Measurement as Assessed on a Heft-Parker 170 mm Visual Analog Scale
"Patients will rate pain on a Heft-Parker visual analog scale during needle insertion, placement, and solution deposition phases of the anesthetic injection(s). Patients will also rate pain during the incision and dissection phases of the incision and drainage procedure. The number of millimeters along the scale are reported. No pain corresponded to 0 mm. Mild pain was defined as greater than 0 mm and less than or equal to 54 mm. Mild pain included the descriptors of faint, weak, and mild pain. Moderate pain was defined as greater than 54 mm and less than 114 mm and included the descriptor moderate. Severe pain was defined as equal to or greater than 114 mm up to and including 170 mm. Severe pain included the descriptors of strong, intense, and maximum possible." (NCT01981772)
Timeframe: during incision/drainage on Day 0
Intervention | units on a scale (Mean) |
---|
Buffered Lidocaine | 69.3 |
Nonbuffered Lidocaine | 59.2 |
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Postoperative Satisfaction on a 100 mm Visual Analog Scale
"Patients will rate their level of satisfaction with the incision and drainage procedure using a visual analog scale. The scale ranges from not satisfied, to somewhat satisfied, to moderately satisfied, to completely satisfied. Not satisfied corresponded to 0 mm. Somewhat satisfied was defined as greater than 0 mm and less than or equal to 33 mm. Moderately satisfied was defined as greater than 33 mm and less than 66 mm. Completely satisfied was defined as equal to or greater than 66 mm. Measurements along the scale were collected and analyzed by randomization test." (NCT01981772)
Timeframe: immediately post-procedure on Day 0
Intervention | units on a scale (Mean) |
---|
Buffered Lidocaine | 92.7 |
Nonbuffered Lidocaine | 89.5 |
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Change From Baseline in Pain Assessment Using McGill Pain Questionnaire
Participants rated 15 pain characteristics by using a number to signify how much of that specific type of pain they were experiencing using the Short-Form McGill Pain Questionnaire. The pain characteristic options included Throbbing, Shooting, Stabbing, Sharp, Cramping, Gnawing, Hot-burning, Aching, Heavy, Tender, Splitting, Tiring-exhausting, Sickening, Fearful, and Punishing- cruel. Participants assessed the intensity of each characteristic using the following score system: none (0), mild (1), moderate (2), and severe (3). In addition, present pain was assessed on a scale from 0 (no pain) to 5 (excruciating). (NCT02007434)
Timeframe: Baseline (predose) and Day 84
Intervention | units on a scale (Mean) |
---|
| Throbbing | Shooting | Stabbing | Sharp | Cramping | Gnawing | Hot-Burning | Aching | Heavy | Tender | Splitting | Tiring-Exhausting | Sickening | Fearful | Punishing-Cruel | Present pain |
---|
Paradigm 1 / Deoxycholic Acid Injection | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 |
,Paradigm 1 / Placebo | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 |
,Paradigm 2 / Deoxycholic Acid Injection | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.1 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 |
,Paradigm 2 / Placebo | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 |
,Paradigm 3 / Deoxycholic Acid Injection | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.1 | 0.1 | 0.1 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 |
,Paradigm 3 / Placebo | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 |
,Paradigm 4 / Deoxycholic Acid Injection | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 |
,Paradigm 4 / Placebo | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 |
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Change From Baseline in Submental Skin Laxity Grades (SMSLG)
Skin laxity assessment was based on clinical evaluation and palpation of the submental area on the following scale: 1 = no laxity; 2 = mild laxity; 3 = moderate laxity; 4 = severe laxity. A negative change from Baseline indicates improvement. (NCT02007434)
Timeframe: Baseline and Day 84
Intervention | units on a scale (Mean) |
---|
Paradigm 1 / Deoxycholic Acid Injection | 0.2 |
Paradigm 1 / Placebo | 0.0 |
Paradigm 2 / Deoxycholic Acid Injection | 0.1 |
Paradigm 2 / Placebo | 0.5 |
Paradigm 3 / Deoxycholic Acid Injection | 0.3 |
Paradigm 3 / Placebo | 0.5 |
Paradigm 4 / Deoxycholic Acid Injection | 0.3 |
Paradigm 4 / Placebo | 0.3 |
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Bruising Grading Scale Scores
"The following grading system was used for the assessment of bruising:~Bruising absent (0)~Bruising associated with 1 to 3 needle insertion points (1)~Bruising spreading beyond 4 or more individual needle insertion points but contained within the treatment area (2)~Bruising covering the entire treatment area but contained within the treatment area (3)~Bruising of the neck and face beyond the treatment area (4)" (NCT02007434)
Timeframe: Day 84
Intervention | units on a scale (Mean) |
---|
Paradigm 1 / Deoxycholic Acid Injection | 0.0 |
Paradigm 1 / Placebo | 0.0 |
Paradigm 2 / Deoxycholic Acid Injection | 0.0 |
Paradigm 2 / Placebo | 0.0 |
Paradigm 3 / Deoxycholic Acid Injection | 0.0 |
Paradigm 3 / Placebo | 0.0 |
Paradigm 4 / Deoxycholic Acid Injection | 0.0 |
Paradigm 4 / Placebo | 0.0 |
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Change From Baseline in Clinician-Reported Submental Fat Rating Scale (CR-SMFRS)
The CR-SMFRS score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme. A negative change from Baseline indicates improvement. (NCT02007434)
Timeframe: Baseline and Day 84
Intervention | units on a scale (Mean) |
---|
Paradigm 1 / Deoxycholic Acid Injection | -0.6 |
Paradigm 1 / Placebo | -0.7 |
Paradigm 2 / Deoxycholic Acid Injection | -0.6 |
Paradigm 2 / Placebo | -0.8 |
Paradigm 3 / Deoxycholic Acid Injection | -0.4 |
Paradigm 3 / Placebo | 0.0 |
Paradigm 4 / Deoxycholic Acid Injection | -0.4 |
Paradigm 4 / Placebo | -0.3 |
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Change From Baseline in Pain Visual Analog Scale Scores
Participants were provided with a scale 100 mm in length and were asked to mark the place on the line that best represents his or her pain associated with the area treated with study drug. The scale ranged from 0 (no pain) to 100 (most severe pain possible). (NCT02007434)
Timeframe: Baseline and Day 84
Intervention | units on a scale (Median) |
---|
Paradigm 1 / Deoxycholic Acid Injection | 0.0 |
Paradigm 1 / Placebo | 0.0 |
Paradigm 2 / Deoxycholic Acid Injection | 0.0 |
Paradigm 2 / Placebo | 0.0 |
Paradigm 3 / Deoxycholic Acid Injection | 0.0 |
Paradigm 3 / Placebo | 0.0 |
Paradigm 4 / Deoxycholic Acid Injection | 0.0 |
Paradigm 4 / Placebo | 0.0 |
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Change From Baseline in Patient-Reported Submental Fat Rating Scale (PR-SMFRS)
"The PR-SMFRS is based on the participant's response to the question How much fat do you have under your chin right now? answered on a 5-point ordinal scale (0-4) with 0 = no chin fat at all, 1 = a slight amount of chin fat, 2 = a moderate amount of chin fat, 3 = a large amount of chin fat, and 4 = a very large amount of chin fat. A negative change from Baseline indicates improvement." (NCT02007434)
Timeframe: Baseline and Day 84
Intervention | units on a scale (Mean) |
---|
Paradigm 1 / Deoxycholic Acid Injection | -1.2 |
Paradigm 1 / Placebo | -0.7 |
Paradigm 2 / Deoxycholic Acid Injection | -0.9 |
Paradigm 2 / Placebo | -0.5 |
Paradigm 3 / Deoxycholic Acid Injection | -0.8 |
Paradigm 3 / Placebo | -0.8 |
Paradigm 4 / Deoxycholic Acid Injection | -0.7 |
Paradigm 4 / Placebo | -0.5 |
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Change From Baseline in Subject Self Rating Scale (SSRS)
The SSRS assesses participant's satisfaction with their appearance in association with the face and chin on a 7-point scale from 0 to 6: where 0 = Extremely dissatisfied, 1 = Dissatisfied, 2 = Slightly dissatisfied, 3 = Neither satisfied nor dissatisfied, 4 = Slightly satisfied, 5 = Satisfied and 6 = Extremely satisfied. A positive change from Baseline indicates improvement. (NCT02007434)
Timeframe: Baseline and Day 84
Intervention | units on a scale (Mean) |
---|
Paradigm 1 / Deoxycholic Acid Injection | 2.8 |
Paradigm 1 / Placebo | 2.3 |
Paradigm 2 / Deoxycholic Acid Injection | 3.2 |
Paradigm 2 / Placebo | 1.8 |
Paradigm 3 / Deoxycholic Acid Injection | 2.3 |
Paradigm 3 / Placebo | 2.3 |
Paradigm 4 / Deoxycholic Acid Injection | 2.4 |
Paradigm 4 / Placebo | 2.0 |
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Change From Baseline in Submental Fat Thickness
Submental thickness was measured using caliper devices. (NCT02007434)
Timeframe: Baseline and Day 84
Intervention | mm (Mean) |
---|
Paradigm 1 / Deoxycholic Acid Injection | -1.4 |
Paradigm 1 / Placebo | -2.3 |
Paradigm 2 / Deoxycholic Acid Injection | -1.6 |
Paradigm 2 / Placebo | -0.3 |
Paradigm 3 / Deoxycholic Acid Injection | -0.9 |
Paradigm 3 / Placebo | -2.3 |
Paradigm 4 / Deoxycholic Acid Injection | -1.5 |
Paradigm 4 / Placebo | -2.8 |
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Induration Grading Scale Scores
"The following grading system was used for the assessment of induration:~Induration absent to minimal (0)~Induration associated with at least approximately 30% of the treatment area (1)~Induration associated with greater than approximately 30% to at least 60% of the treatment area (2)~Induration covering the entire treatment area but contained within the treatment area (3)~Induration of the neck and face beyond the treatment area (4)" (NCT02007434)
Timeframe: Day 84
Intervention | units on a scale (Mean) |
---|
Paradigm 1 / Deoxycholic Acid Injection | 0.0 |
Paradigm 1 / Placebo | 0.0 |
Paradigm 2 / Deoxycholic Acid Injection | 0.1 |
Paradigm 2 / Placebo | 0.0 |
Paradigm 3 / Deoxycholic Acid Injection | 0.0 |
Paradigm 3 / Placebo | 0.0 |
Paradigm 4 / Deoxycholic Acid Injection | 0.1 |
Paradigm 4 / Placebo | 0.0 |
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Swelling Grading Scale Scores
"The following grading system was used for the assessment of swelling:~Swelling/edema absent (0)~Minimal swelling/edema contained within treatment area (1)~Modest swelling/edema contained within treatment area (2)~Substantial swelling/edema contained within treatment area (3)~Swelling/edema of the neck and face beyond the treatment area (4)" (NCT02007434)
Timeframe: Day 84
Intervention | units on a scale (Mean) |
---|
Paradigm 1 / Deoxycholic Acid Injection | 0.0 |
Paradigm 1 / Placebo | 0.0 |
Paradigm 2 / Deoxycholic Acid Injection | 0.0 |
Paradigm 2 / Placebo | 0.0 |
Paradigm 3 / Deoxycholic Acid Injection | 0.0 |
Paradigm 3 / Placebo | 0.0 |
Paradigm 4 / Deoxycholic Acid Injection | 0.0 |
Paradigm 4 / Placebo | 0.0 |
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Patient Experience Questions
"Participants were asked to complete 3 patient experience questions, each answered as Yes or No:~Given your experience in this study:~Would you recommend this procedure to a friend?~Would you agree to receive additional treatments?~Has the treatment you received in this study affected your normal activities?~The percentage of participants answering Yes on each question is reported." (NCT02007434)
Timeframe: Day 84
Intervention | percentage of participants (Number) |
---|
| Recommend to a Friend | Receive Additional Treatments | Normal Activity Affected |
---|
Paradigm 1 / Deoxycholic Acid Injection | 81 | 81 | 13 |
,Paradigm 1 / Placebo | 33 | 67 | 0 |
,Paradigm 2 / Deoxycholic Acid Injection | 81 | 88 | 13 |
,Paradigm 2 / Placebo | 50 | 50 | 0 |
,Paradigm 3 / Deoxycholic Acid Injection | 94 | 94 | 19 |
,Paradigm 3 / Placebo | 100 | 100 | 0 |
,Paradigm 4 / Deoxycholic Acid Injection | 72 | 78 | 11 |
,Paradigm 4 / Placebo | 75 | 100 | 25 |
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Post Operative Pain Control
The primary objective is to evaluate analgesia following local infiltration of 30 mL Exparel or the same volume of 0.25% bupivacaine HCl with epinephrine or normal saline. The intensity of pain will be measured using a numerical rating scale (NRS-11) in which 0 represents no pain, and 10 represents extreme pain. (NCT02104414)
Timeframe: up to 4 days
Intervention | score on a scale (Mean) |
---|
| Hour 1 | Hour 2 | Day 1 | Day 2 | Day 3 | Day 4 |
---|
Bupivacaine HCl With Epinephrine | 1.33 | 1.0 | 6.5 | 4.5 | 5.0 | 3.0 |
,Exparel | 0 | 0 | 5.75 | 3 | 2.25 | 2.67 |
,Normal Saline | 7 | 2.5 | 5.5 | 4 | 3 | 2 |
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Number of Participants With Urinary Retention
(NCT02104414)
Timeframe: up to 4 days
Intervention | Participants (Count of Participants) |
---|
| Day 1 | Day 2 | Day 3 | Day 4 |
---|
Bupivacaine HCl With Epinephrine | 0 | 0 | 0 | 0 |
,Exparel | 0 | 0 | 0 | 0 |
,Normal Saline | 0 | 0 | 0 | 0 |
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Postoperative Opioid Consumption - Hydromorphone I.V
(NCT02104414)
Timeframe: 1 hour and 2 hours post op
Intervention | mg (Mean) |
---|
| Hour 1 | Hour 2 |
---|
Bupivacaine HCl With Epinephrine | 0 | 0 |
,Exparel | 0.35 | 0.5 |
,Normal Saline | 0.8 | 0.6 |
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Number of Participants With Pain During Bowel Movements
Number of participants with pain during postoperative bowel movements (NCT02104414)
Timeframe: Hourly from PACU arrival to discharge and Q4H from 10:00-22:00 postoperatively for 4 days
Intervention | Participants (Count of Participants) |
---|
| Day 1 | Day 2 | Day 3 | Day 4 |
---|
Bupivacaine HCl With Epinephrine | 1 | 3 | 4 | 4 |
,Exparel | 1 | 2 | 5 | 5 |
,Normal Saline | 1 | 1 | 2 | 2 |
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Number of Participants With Postoperative Nausea and Vomiting
Number of participants with postoperative nausea and vomiting episodes (NCT02104414)
Timeframe: up to 4 days
Intervention | Participants (Count of Participants) |
---|
| Hour 1 | Hour 2 | Day 1 | Day 2 | Day 3 | Day 4 |
---|
Bupivacaine HCl With Epinephrine | 0 | 0 | 0 | 0 | 0 | 0 |
,Exparel | 0 | 0 | 0 | 0 | 0 | 0 |
,Normal Saline | 0 | 0 | 0 | 0 | 0 | 0 |
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Number of Oxycodone Tablets Taken
Number of postoperative opioid consumption - oxycodone tablets (5mg each) (NCT02104414)
Timeframe: up to 4 days
Intervention | tablets (Mean) |
---|
| Hour 1 | Hour 2 | Day 1 | Day 2 | Day 3 | Day 4 |
---|
Bupivacaine HCl With Epinephrine | 0 | 0 | 2.67 | 1.67 | 1.5 | 1 |
,Exparel | 0 | 0 | 2.2 | 2 | 1.4 | 2 |
,Normal Saline | 0 | 0 | 1.5 | 2.5 | 2.5 | 1.5 |
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Operation Time
The amount of time taken from start to the end of surgery (NCT02112370)
Timeframe: participants were followed for the duration of the operation, an average of approximately 2.5 hours
Intervention | minutes (Mean) |
---|
Normal Saline Injection | 163.6 |
Ropivacaine With Epinephrine Injection | 155.3 |
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Pain Killer Dose
Change in pain killer usage with time (NCT02112370)
Timeframe: 0, 1, 2, 4, 6, 9, 12, 24, and 48 hours post operation
Intervention | vials (15mg ketorolac per vial) (Mean) |
---|
| 0 hour | 1 hour | 2 hour | 4 hour | 6 hour | 9 hour | 12 hour | 24 hour | 48 hour |
---|
Normal Saline Injection | 1 | 0.35 | 0.31 | 0.07 | 0.18 | 0.14 | 0.18 | 0.20 | 0.01 |
,Ropivacaine With Epinephrine Injection | 0.84 | 0.31 | 0.26 | 0.11 | 0.15 | 0.12 | 0.19 | 0.16 | 0.07 |
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NRS Change
"Change in NRS score a with time The numerical rating scale is utilized to assess the postoperative pain change for the first 12 hours according to location.~Range: 0(minimal pain, better outcome) ~ 10(maximum pain, worse outcome)" (NCT02112370)
Timeframe: 0, 1, 2, 4, 6, 9, 12, 24, and 48 hours post operation
Intervention | scores on a scale (Mean) |
---|
| 0 hour | 1 hour | 2 hour | 4 hour | 6 hour | 9 hour | 12 hour | 24 hour | 48 hour |
---|
Normal Saline Injection | 5.73 | 5.05 | 4.55 | 3.55 | 3.39 | 3.28 | 3.19 | 2.93 | 2.27 |
,Ropivacaine With Epinephrine Injection | 5.68 | 4.7 | 4.11 | 3.34 | 3.28 | 3.14 | 3.18 | 2.95 | 2.08 |
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NRS Pain Scores for the First 12 Hours
"The numerical rating scale is utilized to assess the postoperative pain change for the first 12 hours according to location.~Range: 0(minimal pain, better outcome) ~ 10(maximum pain, worse outcome)~Unlike the general NRS pain score as reported in the post-operative 48 hour result which deals with post-operative discomfort in general, this outcome measures the pain score of the specific location in which flap dissection had taken place." (NCT02112370)
Timeframe: Postoperative 12 hours
Intervention | points (Mean) |
---|
| Swallowing difficulty | Anterior neck pain | Right chest pain | Left chest pain | Back pain | Posterior neck pain |
---|
Normal Saline Injection | 4.93 | 4.50 | 3.99 | 3.74 | 0.65 | 1.47 |
,Ropivacaine With Epinephrine Injection | 4.12 | 3.69 | 3.16 | 4.51 | 0.28 | 1.65 |
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Blood Loss Amount
The blood loss amount is estimated at the end of surgery. (NCT02112370)
Timeframe: participants were followed for the duration of the operation, an average of approximately 2.5 hours
Intervention | ml (Mean) |
---|
Normal Saline Injection | 30 |
Ropivacaine With Epinephrine Injection | 18 |
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Maximum of Measured Diastolic Blood Pressures
The maximal diastolic blood pressure is monitored during surgery. (NCT02112370)
Timeframe: participants were followed for the duration of the operation, an average of approximately 2.5 hours
Intervention | mmHg (Mean) |
---|
Normal Saline Injection | 91 |
Ropivacaine With Epinephrine Injection | 86 |
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Maximum of Measured Heart Rates
The maximal heart rate is monitored during surgery. (NCT02112370)
Timeframe: participants were followed for the duration of the operation, an average of approximately 2.5 hours
Intervention | beats per minute (Mean) |
---|
Normal Saline Injection | 88 |
Ropivacaine With Epinephrine Injection | 99 |
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Maximum of Measured Systolic Blood Pressures
The maximal systolic blood pressure is monitored during surgery. (NCT02112370)
Timeframe: participants were followed for the duration of the operation, an average of approximately 2.5 hours
Intervention | mmHg (Mean) |
---|
Normal Saline Injection | 142 |
Ropivacaine With Epinephrine Injection | 145 |
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Number of Patients Who Developed Post-ERCP Pancreatitis
The primary outcome variable of interest is the incidence of post ERCP pancreatitis (PEP) as defined by the consensus guidelines as 1) New or increased abdominal pain that is clinically consistent with a syndrome of acute pancreatitis and 2) amylase or lipase ≥ 3x the upper limit of normal 24 hours after the procedure and 3) Hospitalization or prolongation of existing hospitalization for at least 2 days. (NCT02116309)
Timeframe: 24 hours after ERCP
Intervention | Participants (Count of Participants) |
---|
Rectal Indomethacin Only | 31 |
Rectal Indomethacin Plus Papillary Spray of Epinephrine | 32 |
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Number of Patients Who Developed Severe Post-ERCP Pancreatitis
Severity of PEP defined using the consensus grading as Mild PEP that results in hospitalization (or prolongation of existing hospitalization) for ≤3 days. Moderate PEP will be defined as PEP that results in hospitalization (or prolongation of existing hospitalization) for 4-10 days. Severe PEP will be defined as PEP that results in hospitalization (or prolongation of existing hospitalization) for > 10 days, or leads to the development of pancreatic necrosis or pseudocyst, or requires additional endoscopic, percutaneous, or surgical intervention. (NCT02116309)
Timeframe: up to 30 days after ERCP
Intervention | Participants (Count of Participants) |
---|
Rectal Indomethacin Only | 4 |
Rectal Indomethacin Plus Papillary Spray of Epinephrine | 7 |
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Quality of Recovery
Quality of Recovery Score (QoR-15) is measured on a scale of 0-150 (0=poor, 150 = excellent). Scores were collected daily for 72 hours and then averaged. (NCT02164929)
Timeframe: 72 hours
Intervention | Units on a scale (Mean) |
---|
Paravertebral Block | 89.5 |
TAP Block | 117 |
Epidural | 115.5 |
No Block (PCA Alone) | 99 |
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Time to First Bowel Movement
(NCT02164929)
Timeframe: Participants will be followed for the duration of hospital stay, an estimated 1 week
Intervention | days (Mean) |
---|
Paravertebral Block | 1 |
TAP Block | 2 |
Epidural | 1 |
No Block (PCA Alone) | 2 |
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Time to First Ingestion of Solid Food
(NCT02164929)
Timeframe: Participants will be followed for the duration of hospital stay, an estimated 1 week
Intervention | Days (Mean) |
---|
Paravertebral Block | 1 |
TAP Block | 2 |
Epidural | 0.75 |
No Block (PCA Alone) | 1.5 |
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Length of Stay
(NCT02164929)
Timeframe: Participants will be followed for the duration of hospital stay, an estimated 1 week
Intervention | Days (Mean) |
---|
Paravertebral Block | 2.66 |
TAP Block | 4.33 |
Epidural | 4 |
No Block (PCA Alone) | 3.5 |
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Pain Scores
"Pain scores at rest and with activity using a verbal rating scales (VRS) of 0-10, where 0 represents no pain and 10 represents worst pain ever, at 30, 60, 90, 120 min and every 6 hours for 24 hours and every 12 hours for 48 hours and once a day thereafter until discharge. Data were collected at the indicated time points and an average pain score was calculated." (NCT02164929)
Timeframe: Participants will be followed for the duration of hospital stay, an estimated 1 week
Intervention | Units on a scale (Mean) |
---|
Paravertebral Block | 4.66 |
TAP Block | 2.66 |
Epidural | 1.75 |
No Block (PCA Alone) | 6 |
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Postoperative Opioid Consumption
If opioid other than fentanyl is used, the dose will be converted to morphine equivalent. (NCT02164929)
Timeframe: 24 hours after surgery
Intervention | mcg (Mean) |
---|
Paravertebral Block | 734 |
TAP Block | 666 |
Epidural | 125 |
No Block (PCA Alone) | 1017.5 |
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Length of Stay in Hospital (Days)
(NCT02197273)
Timeframe: Participants were followed for the duration of hospital stay, an expected average of 3 days
Intervention | days (Median) |
---|
Standard of Care Analgesia | 2.0 |
Liposomal Bupivacaine | 2.0 |
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Readmission or Emergency Department (ED) Visit Due to Pain Control Within 30 Days
(NCT02197273)
Timeframe: Date of discharge through 30 days following discharge
Intervention | participants (Number) |
---|
Standard of Care Analgesia | 2 |
Liposomal Bupivacaine | 4 |
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Time to Post-operative Rescue Opioids (Hours)
(NCT02197273)
Timeframe: Immediately following discharge from operating room until the participant was discharged from the hospital, an expected average of 3 days
Intervention | hours (Median) |
---|
Standard of Care Analgesia | 7.7 |
Liposomal Bupivacaine | 11.8 |
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Post-Operative Pain Score
Pain intensity (NRS) assessment at 3 month follow-up. Pain was measured on an ascending numeric rating scale (NRS) from 0-10 where 1-3 equaled mild pain, 4-6 equaled moderate pain, 7-9 equaled severe pain, and 10 equaled worst possible pain. (NCT02242201)
Timeframe: 3 month follow-up
Intervention | units on a scale (Median) |
---|
| Pain at rest | Pain with movement |
---|
PAI Liposomal Bupivacaine | 0 | 1 |
,PAI Ropivacaine | 0 | 1 |
,PNB Bupivacaine | 0 | 0 |
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Maximum Postoperative Pain Score
Pain was measured on an ascending numeric rating scale (NRS) from 0-10 where 1-3 equaled mild pain, 4-6 equaled moderate pain, 7-9 equaled severe pain, and 10 equaled worst possible pain. (NCT02242201)
Timeframe: Post-Operative Day 1 (0600-1200)
Intervention | units on a scale (Median) |
---|
PNB Bupivacaine | 3.0 |
PAI Ropivacaine | 4.0 |
PAI Liposomal Bupivacaine | 3.0 |
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Number of Participants Reporting Complications Since Surgery
Complications were collected by telephone interview after surgery. (NCT02242201)
Timeframe: Post-operative Day 1 Through 3 - Month Follow-up
Intervention | Participants (Count of Participants) |
---|
| Operative extremity neurologic changes | Wound infection | Fall requiring medical attention |
---|
PAI Liposomal Bupivacaine | 2 | 1 | 1 |
,PAI Ropivacaine | 1 | 1 | 2 |
,PNB Bupivacaine | 1 | 0 | 1 |
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Total Opioid Consumption During Hospitalization
Measured in daily oral morphine equivalents (OME) (NCT02242201)
Timeframe: Preoperative, Intraoperative, Postanesthesia Care Unit (PACU), Post Operative Day (POD) 0, day 1, and day 2
Intervention | Oral morphine equivalent in milligrams (Median) |
---|
| Preoperative | Intraoperative | Postanesthesia Care Unit (PACU) | Post Operative Day (POD) 0 post PACU | POD 1 | POD 2 |
---|
PAI Liposomal Bupivacaine | 15 | 10 | 0 | 11.3 | 15 | 11.3 |
,PAI Ropivacaine | 15 | 10 | 0 | 15 | 33.8 | 15 |
,PNB Bupivacaine | 15 | 10 | 0 | 7.5 | 22.5 | 15 |
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Number of Participants Reporting a NRS Pain Score Greater Than 3
Pain was measured on an ascending numeric rating scale (NRS) from 0-10 where 1-3 equaled mild pain, 4-6 equaled moderate pain, 7-9 equaled severe pain, and 10 equaled worst possible pain. (NCT02242201)
Timeframe: 3 month follow up
Intervention | Participants (Count of Participants) |
---|
| Pain at rest | Pain with movement |
---|
PAI Liposomal Bupivacaine | 1 | 2 |
,PAI Ropivacaine | 1 | 4 |
,PNB Bupivacaine | 0 | 0 |
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Change in Unipedal Stance Time
Length of time in seconds a patient could stand on involved leg (NCT02242201)
Timeframe: Baseline, 3 months
Intervention | seconds (Median) |
---|
| Baseline | 3 months |
---|
PAI Liposomal Bupivacaine | 30 | 30 |
,PAI Ropivacaine | 30 | 30 |
,PNB Bupivacaine | 24.5 | 30 |
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Hospital Length of Stay
Discharge readiness was evaluated by the surgical team during morning and afternoon physical therapy sessions. (NCT02242201)
Timeframe: Post-operative Day 1 through discharge (approximately 3 days)
Intervention | days (Median) |
---|
PNB Bupivacaine | 2 |
PAI Ropivacaine | 2 |
PAI Liposomal Bupivacaine | 2 |
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Change in Heart Rate
Change from baseline in heart rate. (NCT02285634)
Timeframe: baseline, 30 minutes
Intervention | beats/min (Mean) |
---|
Oxymetazoline 0.05% | 2.8 |
Phenylephrine 0.25% | 5.2 |
Lidocaine 1% Plus Epinephrine 1:100,000 | 7.5 |
Bacteriostatic 0.9% NaCL | 6.8 |
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Change in Diastolic Blood Pressure
Change from baseline in diastolic blood pressure. (NCT02285634)
Timeframe: baseline, 30 minutes
Intervention | mmHg (Mean) |
---|
Oxymetazoline 0.05% | 5.7 |
Phenylephrine 0.25% | 7.9 |
Lidocaine 1% Plus Epinephrine 1:100,000 | 6.2 |
Bacteriostatic 0.9% NaCL | 9.3 |
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Change in Systolic Blood Pressure
Change from baseline in systolic blood pressure. (NCT02285634)
Timeframe: baseline, 30 minutes
Intervention | mmHg (Mean) |
---|
Oxymetazoline 0.05% | 7.5 |
Phenylephrine 0.25% | 8.2 |
Lidocaine 1% Plus Epinephrine 1:100,000 | 3.5 |
Bacteriostatic 0.9% NaCL | 8.9 |
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Change in Mean Arterial Blood Pressure
Change in mean arterial blood pressure from the baseline measurement (NCT02285634)
Timeframe: baseline, 30 minutes
Intervention | mmHg (Mean) |
---|
Oxymetazoline 0.05% | 5.1 |
Phenylephrine 0.25% | 6.4 |
Lidocaine 1% Plus Epinephrine 1:100,000 | 4.6 |
Bacteriostatic 0.9% NaCL | 6.5 |
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Pain Scores (Visual Analog Pain Scores)
visual analog pain scores (scale 0=no pain; 10=worst pain imaginable) (NCT02299349)
Timeframe: 1 day following surgery
Intervention | units on a scale (Mean) |
---|
Bupivacaine Liposome Suspension | 2.6 |
Concentrated Multi Drug Injection | 3.3 |
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MS04 Equivalent Consumption
in hospital total MS04 equivalent consumption (NCT02299349)
Timeframe: 1 day following surgery
Intervention | mg (Median) |
---|
Bupivacaine Liposome Suspension | 10.0 |
Concentrated Multi Drug Injection | 15.0 |
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Hospital Readmission
Number of participants that were readmitted to the hospital (NCT02365961)
Timeframe: 3 months
Intervention | Participants (Count of Participants) |
---|
FI Block | 1 |
Local Injection | 2 |
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Visual Analog Scale
Pain, as measured by Visual Analog Scale (VAS). Scores are ranged from 0-10, 0 is no pain and 10 is worst possible pain. The unit of measure is units on a scale. (NCT02365961)
Timeframe: 3 Months
Intervention | units on a scale (Mean) |
---|
FI Block | 2.65 |
Local Injection | 2.50 |
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Total Number of Episodes of Nausea and Vomiting
Occurrences of periods of nausea and vomiting (NCT02365961)
Timeframe: From end of surgery to discharge from PACU
Intervention | Number of episodes (Number) |
---|
FI Block | 11 |
Local Injection | 7 |
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Time in PACU
Measured time subjects spent in the post anesthesia care unit. (NCT02365961)
Timeframe: Duration of PACU stay in minutes from end of surgery to discharge from PACA
Intervention | Minutes (Mean) |
---|
FI Block | 150.04 |
Local Injection | 151.59 |
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Opioid Consumption
Opioid consumption, as measured by narcotic usage (morphine milligram equivalents) (NCT02365961)
Timeframe: 3 Months
Intervention | morphine milligram equivalents (Mean) |
---|
FI Block | 26.87 |
Local Injection | 30.32 |
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Block Onset
Time to a onset of T4 level of anesthesia or the highest level achieved in 15min (NCT02369510)
Timeframe: up to 15 min
Intervention | minutes (Median) |
---|
Low-dose Epinephrine | 6 |
High-dose Epinephrine | 8 |
No Epinephrine | 8 |
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Motor Recovery
Time to Bromage 3 motor recovery (NCT02369510)
Timeframe: up to 4 hours
Intervention | minutes (Median) |
---|
Low-dose Epinephrine | 150 |
High-dose Epinephrine | 172 |
No Epinephrine | 120 |
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Patient Satisfaction
"Patient satisfaction score was elicited upon arrival to the recovery room on a 1-5 Likert scale. Number of participants selecting the highest score of 5 or completely satisfied." (NCT02369510)
Timeframe: up to 3 hours
Intervention | percentage of participants (Number) |
---|
Low-dose Epinephrine | 90 |
High-dose Epinephrine | 85 |
No Epinephrine | 87 |
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Sensory Recovery
Time to T10 sensory recovery as measured by pinprick sensation (NCT02369510)
Timeframe: up to 3 hours
Intervention | minutes (Median) |
---|
Low-dose Epinephrine | 135 |
High-dose Epinephrine | 165 |
No Epinephrine | 120 |
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Incidence of Nausea and Vomiting
(NCT02369510)
Timeframe: up to 3 hours
Intervention | Participants (Count of Participants) |
---|
| 2 minutes | 25 minutes |
---|
High-dose Epinephrine | 0 | 6 |
,Low-dose Epinephrine | 2 | 3 |
,No Epinephrine | 4 | 1 |
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Adequacy of Anesthesia
As measured by pinprick sensation and/or patient discomfort as measured by verbal pain score on a scale of 0=no pain to 10=worst imaginable pain, obtained within 3 hours of receiving anesthesia. (NCT02369510)
Timeframe: up to 3 hrs
Intervention | units on a scale (Median) |
---|
Low-dose Epinephrine | 0 |
High-dose Epinephrine | 0 |
No Epinephrine | 0 |
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Number of Participants With Hypotension
Incidence of hypotension as measured by participants needing vasopressor agents (NCT02369510)
Timeframe: at 2 minutes and at 25 minutes
Intervention | Participants (Count of Participants) |
---|
| 2 minutes | 25 minutes |
---|
High-dose Epinephrine | 2 | 9 |
,Low-dose Epinephrine | 5 | 3 |
,No Epinephrine | 8 | 3 |
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Participants Anesthetic Preference
Patient will complete a questionnaire to evaluate his/her preference of anesthetic modality. (NCT02379221)
Timeframe: one week post treatment
Intervention | participant preference selection (Number) |
---|
Injectable | 32 |
Topical | 16 |
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Mean Pain Level Associated With Facial Filler Injection to the Nasolabial Fold
Participant will complete a questionnaire to evaluate his/her pain level perception using a Visual Analog Scale (VAS) during injection of HA filler to the nasolabial fold. The Visual Analog scale uses a 10 cm horizontal line with 'no pain' labeled on the left end of line and 'worst pain' on the right end of line. Participant marks their pain level at any point on the line from no pain to worst pain. No pain= 0 cm, Worst pain=10cm (NCT02379221)
Timeframe: 5-10 minutes post procedure
Intervention | units on a scale (Mean) |
---|
Injectable | 0.76 |
Topical | 2.82 |
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Mean Pain Level Associated With Facial Filler Injection to the Lower Lip
A mean level of pain for all participants completing the Visual Analog Scale (VAS) during injection of HA filler to the lower lip. The Visual Analog scale uses a 10 cm horizontal line with 'no pain' labeled on the left end of line and 'worst pain' on the right end of line. Participant marks their pain level at any point on the line from no pain to worst pain. No pain= 0 cm, Worst pain=10cm. The total score was divided by 48. (NCT02379221)
Timeframe: 5-10 minutes post procedure
Intervention | units on a scale (Mean) |
---|
Injectable | 1.47 |
Topical | 4.38 |
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Mean Pain Level Associated With Facial Filler Injection at the Upper Lip
Participant will complete a questionnaire to evaluate his/her pain level perception using a Visual Analog Scale (VAS) during injection of HA filler to the upper lip. The Visual Analog scale uses a 10 cm horizontal line with 'no pain' labeled on the left end of line and 'worst pain' on the right end of line. Participant marks their pain level at any point on the line from no pain to worst pain. No pain= 0 cm, Worst pain=10cm (NCT02379221)
Timeframe: 5-10 minutes post procedure
Intervention | units on a scale (Mean) |
---|
Injectable | 0.89 |
Topical | 3.67 |
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Mean Pain Level Associated With the Local Anesthetic Injection
Participant will complete a questionnaire to evaluate his/her pain level perception using a Visual Analog Scale (VAS) during injection to the upper and lower lip. The Visual Analog scale uses a 10 cm horizontal line with 'no pain' labeled on the left end of line and 'worst pain' on the right end of line. Participant marks their pain level at any point on the line from no pain to worst pain. No pain= 0 cm, Worst pain=10cm (NCT02379221)
Timeframe: 5-10 minutes post-procedure
Intervention | unit on a scale (Mean) |
---|
Upper Lip | 2.14 |
Lower Lip | 1.89 |
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Mean Pain Level Associated With the Local Topical Anesthetic
Participant will complete a questionnaire to evaluate his/her pain level perception using a Visual Analog Scale (VAS) during application of topical anesthesia to the upper and lower lip. The Visual Analog scale uses a 10 cm horizontal line with 'no pain' labeled on the left end of line and 'worst pain' on the right end of line. Participant marks their pain level at any point on the line from no pain to worst pain. No pain= 0 cm, Worst pain=10cm (NCT02379221)
Timeframe: 5-10 min post procedure
Intervention | units on a scale (Mean) |
---|
Upper Lip | 0.05 |
Lower Lip | 0.11 |
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Rate of Post Operative Nausea and Vomiting
Number of participants that experienced nausea and vomiting was recorded. (NCT02462148)
Timeframe: 0 to 30 hours
Intervention | Participants (Count of Participants) |
---|
4 mg Perineural Dexamethasone Group | 5 |
1 mg Perineural Dexamethasone Group | 14 |
Placebo Group | 4 |
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Time to First Opioid Analgesic Request
Time it took for the first opioid analgesic request was recorded. (NCT02462148)
Timeframe: 0 to 36 hours
Intervention | minutes (Mean) |
---|
4 mg Perineural Dexamethasone Group | 686.18 |
1 mg Perineural Dexamethasone Group | 654.97 |
Placebo Group | 658.17 |
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Verbal Pain Scores
Verbal Pain Scores will be compared between groups as obtained every six hours during hospitalization. Patients will be asked to provide verbal pain scores both at rest and with movement on a scale of 0-10 (0 being no pain and 10 being the worst pain). These scores will be taken at 0, 6, 12, 18, 24, and 30 hours. (NCT02462148)
Timeframe: 0 to 30 hours
Intervention | units on a scale (Mean) |
---|
| 0h | 6h | 12h | 18h | 24h | 30h |
---|
1 mg Perineural Dexamethasone | 2.3 | 1.3 | 2.1 | 1.8 | 1.8 | 3.1 |
,4mg Perineural Dexamethasone | 2.1 | 0.8 | 1.7 | 1.6 | 1.5 | 2.4 |
,Placebo | 2.1 | 1.1 | 3.0 | 3.3 | 3.1 | 4.3 |
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Duration of Sensory Nerve Block
The primary outcome will be time to resolution of the nerve block as assessed by pinprick over the saphenous nerve distribution. Testing will occur every two hours. (NCT02462148)
Timeframe: 12 to 48 hours
Intervention | hours (Mean) |
---|
4 mg Perineural Dexamethasone Group | 37.00 |
1 mg Perineural Dexamethasone Group | 31.75 |
Placebo Group | 29.67 |
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Neurologic Complications
Each patient will be followed for neurologic complications (paresthesias, etc) if they should occur. (NCT02462148)
Timeframe: throughout study completion, up to 48 hours
Intervention | neurological complications (Mean) |
---|
4 mg Perineural Dexamethasone Group | 0 |
1 mg Perineural Dexamethasone Group | 0 |
Placebo Group | 0 |
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Post Operative Opioid Use and Consumption
Amount of opioid use and consumption was recorded. (NCT02462148)
Timeframe: 0-30 hours
Intervention | mg oxycodone equivalents (Mean) |
---|
4 mg Perineural Dexamethasone Group | 27.16 |
1 mg Perineural Dexamethasone Group | 26.04 |
Placebo Group | 42.33 |
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Time to First Analgesic Request
Time (in minutes) will be recorded to first analgesic request following the block placement (NCT02464176)
Timeframe: 30 hours
Intervention | minutes (Median) |
---|
4 mg Dexamethasone Group | 474 |
8 mg Dexamethasone Group | 533 |
Control Group | 432 |
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Duration of Sensory Blockade
The primary outcome will be duration of sensory blockade in the distribution of the lumbar plexus as determined by pin-prick sensation as tested every two hours with pin-prick sensation. (NCT02464176)
Timeframe: 30 hours
Intervention | hours (Mean) |
---|
4 mg Dexamethasone Group | 18.5 |
8 mg Dexamethasone Group | 18.1 |
Control Group | 19.6 |
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Verbal Numeric Pain Score Comparisons
This secondary outcome includes pain scores utilizing the verbal numeric pain score scale (0 to 11). Higher values indicate worse outcomes (higher pain scores). Lower values are better. (NCT02464176)
Timeframe: 24 hour
Intervention | scores on a scale (Median) |
---|
4 mg Dexamethasone Group | 3 |
8 mg Dexamethasone Group | 2 |
Control Group | 3 |
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Total Opioid Consumption
(NCT02464176)
Timeframe: 30 hours
Intervention | oxycodone mg equivalents (Median) |
---|
4 mg Dexamethasone Group | 36.6 |
8 mg Dexamethasone Group | 30 |
Control Group | 39.2 |
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Percentage of Participants Reporting Anaphylaxis and/or Systemic Allergic Reactions
For the purposes of this study, systemic allergic reactions are allergic reactions that occur away from the site of study drug application (allergic reactions other than local application site reactions). Anaphylaxis is a severe allergic reaction that typically involves more than one body system. (NCT02478398)
Timeframe: Up to 35 weeks
Intervention | Percentage of Participants (Number) |
---|
Short Ragweed Pollen Allergen Extract | 0.58 |
Placebo | 0.20 |
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Total Combined Score (TCS) During the Peak Ragweed Season (RS)
TCS is daily symptom score (DSS) plus daily medication score (DMS), assessed in the peak RS (15 consecutive RS days with the highest 15-day average pollen count). The rhinoconjunctivitis (RC) DSS assesses 6 allergy symptoms measured on a scale of 0 to 3 (0=no symptoms, 3=severe symptoms; score range: 0-18). Lower DSS indicates less RC symptoms. The RC DMS is based on use of RC rescue medications (loratadine, olopatadine, mometasone), with different rescue medications being assigned different scores/dose unit (score range: 0-20). Lower DMS indicates less RC medication use. Summed RC DSS+DMS could range from 0 to 38; a lower score indicates less RC symptoms and medication use. Components that contribute to DSS and DMS endpoints are collected in an electronic diary (e-diary) completed by the participant/parent/guardian. Evaluation is based on average TCS during peak RS. (NCT02478398)
Timeframe: The 15-day period during the ragweed season with the highest moving pollen average
Intervention | Score on a scale (Least Squares Mean) |
---|
Short Ragweed Pollen Allergen Extract | 4.39 |
Placebo | 7.12 |
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Percentage of Participants Treated With Epinephrine
Self-injectable epinephrine was provided to each participant/parent/guardian at randomization in countries where it is a regulatory requirement, and was to be available around the time treatment is administered at home. Self-injectable epinephrine was intended for immediate self-administration for an anaphylactic reaction, including symptoms/signs of upper airway obstruction. Instances of treatment with forms of epinephrine other than systemic epinephrine (e.g., inhaled racepinephrine) were counted as use of epinephrine. (NCT02478398)
Timeframe: Up to 35 weeks
Intervention | Percentage of Participants (Number) |
---|
Short Ragween Pollen Allergen Extract | 0.19 |
Placebo | 0.20 |
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Percentage of Participants Reporting Pre-specified Local Application Site Reactions
Pre-specified local application site reactions, irrespective of causality, included AEs related to lip swelling/edema, mouth swelling/edema, palatal swelling/edema, swollen tongue/edema, oropharyngeal swelling/edema, pharyngeal edema/throat tightness, oral pruritus, throat irritation, tongue pruritus, and ear pruritus. (NCT02478398)
Timeframe: Up to 35 weeks
Intervention | Percentage of Participants (Number) |
---|
Short Ragween Pollen Allergen Extract | 64.52 |
Placebo | 26.92 |
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Average TCS During the Entire RS
TCS is DSS plus DMS, assessed here during the entire RS. This starts from the first day of 3 consecutive days with ragweed pollen counts ≥10 grains/m^3 through the last day of the last occurrence of 3 consecutive days with ragweed pollen counts ≥10 grains/m^3. The duration of the entire RS is up to 13 weeks; this duration varies by site/region. The RC DSS assesses 6 allergy symptoms measured on a scale of 0 to 3 (score range: 0-18). A lower DSS indicates less RC symptoms. The RC DMS is based on use of RC rescue medications (loratadine, olopatadine, mometasone) with different scores/dose unit (score range: 0-20). A lower DMS indicates less RC medication use. The sum of RC DSS+DMS ranges from 0 to 38, with a lower score indicating less RC symptoms and medication use. Components contributing to the TCS for the entire RS are collected in an e-diary completed by the participant/parent/guardian. (NCT02478398)
Timeframe: Up to 13 weeks
Intervention | Score on a scale (Least Squares Mean) |
---|
Short Ragweed Pollen Allergen Extract | 3.88 |
Placebo | 5.75 |
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Average Rhinoconjunctivitis (RC) DSS During the Peak RS
The DSS consists of a total of 6 rhinoconjunctivitis symptoms: 4 rhinitis symptoms (runny nose, stuffy nose, sneezing, itchy nose) and 2 conjunctivitis symptoms (itchy eyes, watery eyes). The components that contribute to the DSS endpoint are collected in an e-diary completed by the participant/parent/guardian. The RC DSS is measured on a 4-point scale from 0 to 3 as follows: 0 (no sign/symptom evident) to 3 (sign/symptom that is hard to tolerate; may cause interference with activities of daily living and/or sleeping). The maximum DSS is 18 points if a participant experiences all 6 symptoms with an intensity of 3 for each symptom. The minimum DSS is 0 points if a participant experiences no symptoms. A lower DSS means symptoms are less severe. The evaluation is based on the average DSS during the peak RS. (NCT02478398)
Timeframe: The 15-day period during the ragweed season with the highest moving pollen average
Intervention | Score on a scale (Least Squares Mean) |
---|
Short Ragweed Pollen Allergen Extract | 2.55 |
Placebo | 3.95 |
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Average Rhinoconjunctivitis (RC) DMS During the Peak RS
This DMS endpoint consists of a total of scores for use of RC medications: loratadine syrup or tablets (6 points), olopatadine (6 points), and mometasone (8 points). The score range of the RC DMS is 0-20 points, and a lower DMS means that less medication is used. The method used for analysis of the RC DMS is a zero-inflated log-normal model, which takes the average RC DMS during the peak RS as the response and adjusts for the same terms as in the ANOVA model. The components that contribute to the DMS endpoint are collected in an e-diary completed by the participant/parent/guardian. (NCT02478398)
Timeframe: The 15-day period during the ragweed season with the highest moving pollen average
Intervention | Score on a scale (Mean) |
---|
Short Ragweed Pollen Allergen Extract | 2.01 |
Placebo | 3.85 |
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Maximum Pain Scores as Measured by Numerical Pain Rating Scale (0-10)
the Numerical rating scale goes from 0 (lowest) to 10 (highest). Higher values are a worse outcome. The maximal number for maximal pain scores from 0-72 hours is 30. Thus the range for this outcome is 0 to 30 with 30 being a worse outcome. This is because the 0-72 hour maximal pain scores are additive from the 0-24, 24-48, and 48-72 hours. Each 24 hour subset has a maximal score of 10 and adding all three results in maximal score of 30. (NCT02519023)
Timeframe: 0-72 hours post-procedure
Intervention | scores on a scale (Median) |
---|
TAP-Block With Liposomal Bupivacaine | 8 |
Surgical Infiltration With Bupivacaine | 13 |
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Number of Patients Admitted Post Operatively
(NCT02519023)
Timeframe: 72 hours post-procedure
Intervention | Participants (Count of Participants) |
---|
TAP-Block With Liposomal Bupivacaine | 11 |
Surgical Infiltration With Bupivacaine | 16 |
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Overall Benefit of Analgesia Score (OBAS)
The overall benefit of analgesia score is based off 7 questions given to patients it is scored 0-28. 28 is considered a worse outcome. (NCT02519023)
Timeframe: 72 hours post-procedure
Intervention | scores on a scale (Median) |
---|
TAP-Block With Liposomal Bupivacaine | 2 |
Surgical Infiltration With Bupivacaine | 3 |
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Maximal Pain Score for Patient From Time 24-48 Hours After Surgery
the maximal pain score felt by patient during this time period. This is based on a numerical rating scale of 0-10. 0 is best outcome and 10 is worst outcome. (NCT02519023)
Timeframe: 24-48 hours after surgery
Intervention | units on a scale (Median) |
---|
TAP-Block With Liposomal Bupivacaine | 3 |
Surgical Infiltration With Bupivacaine | 4 |
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Total Opioid Use for Pain Control
total opioid used from time 0 after surgery through 72 hours after surgery was complete. (NCT02519023)
Timeframe: 72 hours
Intervention | mg Morphine equivalents (Median) |
---|
TAP-Block With Liposomal Bupivacaine | 20.8 |
Surgical Infiltration With Bupivacaine | 25.0 |
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Length of Time in Phase 1 and Phase 2 of Recovery
time from start of recovery until patient was deemed ready to discharge from phase 2 recovery. Phase 2 recovery is the phase of the post anesthesia care where patients are readied to be discharge form the post anesthesia care unit. There are guidelines with regards to when patients are able to be discharged and when those points are met by the patient they are deemed ready to discharge. (NCT02519023)
Timeframe: an expected average of 120 mins
Intervention | hours (Median) |
---|
TAP-Block With Liposomal Bupivacaine | 3.3 |
Surgical Infiltration With Bupivacaine | 3.1 |
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Patient Satisfaction With Pain Management
number of patients who answered yes to if they were satisfied with their pain management (NCT02519023)
Timeframe: at 72 hours after surgery
Intervention | Participants (Count of Participants) |
---|
TAP-Block With Liposomal Bupivacaine | 30 |
Surgical Infiltration With Bupivacaine | 24 |
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Maximal Pain Score Patient Felt From 48-72 Hours After Surgery
the maximal pain score felt by patient during this time period. This is based on a numerical rating scale of 0-10. 0 is best outcome and 10 is worst outcome. (NCT02519023)
Timeframe: 48-72 hours after surgery
Intervention | units on a scale (Median) |
---|
TAP-Block With Liposomal Bupivacaine | 2 |
Surgical Infiltration With Bupivacaine | 3 |
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Maximal Pain Score of Patient From Time 0-24 Hours After Surgery
the maximal pain score felt by patient during this time period. This is based on a numerical rating scale of 0-10. 0 is best outcome and 10 is worst outcome. (NCT02519023)
Timeframe: 0-24 hours after surgery
Intervention | units on a scale (Median) |
---|
TAP-Block With Liposomal Bupivacaine | 3 |
Surgical Infiltration With Bupivacaine | 5 |
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Number of Participants With Nausea and Vomiting
(NCT02519023)
Timeframe: 72 hours post-procedure
Intervention | Participants (Count of Participants) |
---|
TAP-Block With Liposomal Bupivacaine | 10 |
Surgical Infiltration With Bupivacaine | 16 |
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Quality of Recovery 15 (QoR15) Score
The quality of recovery is a survey given to patients. It is 15 questions. The scale of the QOR 15 Score is 0 to 150. 150 is a better outcome. (NCT02519023)
Timeframe: 72 hours post-procedure
Intervention | scores on a scale (Median) |
---|
TAP-Block With Liposomal Bupivacaine | 126 |
Surgical Infiltration With Bupivacaine | 115 |
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Total Opioid Taken by Patient as Tabulated and Converted to Morphine Equivalents
opioid use from time 48-72 hours in mg morphine equivalents (NCT02519023)
Timeframe: 48-72 hours after end of surgery
Intervention | mg morphine equivalents (Median) |
---|
TAP-Block With Liposomal Bupivacaine | 0 |
Surgical Infiltration With Bupivacaine | 5 |
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Total Opioid Taken by Patient as Tabulated and Converted to Morphine Equivalents
(NCT02519023)
Timeframe: 0-24 post-procedure
Intervention | mg of morphine equivalents (Median) |
---|
TAP-Block With Liposomal Bupivacaine | 7.5 |
Surgical Infiltration With Bupivacaine | 22.5 |
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Opioid Used From 24-48 Hours Post Surgery
opioids in mg of morphine equivalents used from 24-48 hours after surgery (NCT02519023)
Timeframe: 24-48 hours after the end of surgery
Intervention | mg of morphine equivalents (Median) |
---|
TAP-Block With Liposomal Bupivacaine | 0 |
Surgical Infiltration With Bupivacaine | .5 |
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Opioid Consumption
"Total opioid consumption in the first 24 hrs of recovery after surgery as measured in morphine equivalents. This involves converting the dose of a non-morphine narcotic (e.g. IV hydromorphone or oral hydrocodone) into the equi-analgesic dose of morphine, so that the total amount of narcotic utilized by the patient can be compared. This is a standard technique for comparison utilized in the pain management literature." (NCT02525718)
Timeframe: 24 hrs
Intervention | Morphine equivalents (Median) |
---|
Placebo | 114 |
0.25 % Bupivacaine w/ Epinephrine & 4mg Dexamethasone | 92 |
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Length of Hospital Stay
Number of postoperative days patients stay in the hospital after surgery (NCT02525718)
Timeframe: 4 days
Intervention | Days (Median) |
---|
Placebo | 1 |
0.25 % Bupivacaine w/ Epinephrine & 4mg Dexamethasone | 1 |
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Pain Score Using 10-point Visual Analog Scale (VAS)
"A study-specific pain form was provided to the patient and nursing staff that consisted of standard visual analogue scale (VAS) for patients to rate their pain level. Pain level was rated as a categorical level from 0 to 10, in 1 unit increments, with 0 being no pain at all and 10 being worst pain imaginable. Thus a total of 10 pain grades were possible." (NCT02525718)
Timeframe: 24 hrs
Intervention | score on a scale (Median) |
---|
Placebo | 4 |
0.25 % Bupivacaine w/ Epinephrine & 4mg Dexamethasone | 4 |
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Quality of Recovery Score
"The primary outcome measure is a well-validated and widely used survey measuring the quality of recovery from anesthesia entitled the Global 40 Item Quality of Recovery survey. This is a 40 question survey administered to patients to allow them to rate their quality of recovery along a number of different dimensions, including emotional state, physical comfort, psychological support, physical independence, and pain. The score ranges from 40 to 200, with 40 representing a very poor overall quality of recovery and 200 representing the best possible recovery. The following reference explains the Global 40 Item Quality of Recovery survey in detail:~Myles, P.S., et al., Validity and reliability of a postoperative quality of recovery score: the QoR-40. Br J Anaesth, 2000. 84(1): p. 11-5.~PMID: 10740540" (NCT02525718)
Timeframe: 24 hours post-operatively
Intervention | score on a scale (Median) |
---|
Placebo | 165 |
0.25 % Bupivacaine w/ Epinephrine & 4mg Dexamethasone | 169 |
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Morphine Requirement
Compare ultrasound-guided block of the transversus abdominis plane (TAP) vs laparoscopic-guided TAP block, versus no TAP block on opioid consumption in the first 24 hours. Patients hospital chart was queried for use of any intravenous opioid in the first 24 hours after surgery including fentanyl or hydromorphone and conversion to morphine per standard opioid dose conversion. Total morphine equivalents then summed for the 24 hour postoperative period and compared between groups. (NCT02538679)
Timeframe: 24 hours
Intervention | mg (Mean) |
---|
PLACEBO | 31.4 |
US TAP Bupivacaine/Epinephrine | 39 |
Lap TAP Bupivacaine/Epinephrine | 22.8 |
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Length of Stay
Measured in hours (NCT02543801)
Timeframe: Start of surgery to hospital discharge up to 140 hours
Intervention | Hours (Mean) |
---|
Hip Cohort Liposomal Bupivacaine | 33.8 |
Hip Cohort Ropivacaine | 50.3 |
Knee Cohort Liposomal Bupivacaine | 36.0 |
Knee Cohort Ropivacaine | 38.4 |
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Narcotic Consumption
Total amount of narcotics administered as calculated in oral morphine equivalent dose immediate post operatively up to 48 hours. (NCT02543801)
Timeframe: Starting immediately post operatively up to 48 hours
Intervention | morphine equivalents (Mean) |
---|
Hip Cohort Liposomal Bupivacaine | 48.8 |
Hip Cohort Ropivacaine | 57.4 |
Knee Cohort Liposomal Bupivacaine | 52.2 |
Knee Cohort Ropivacaine | 50.0 |
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Pain Score
"Self-reported pain score 0-10 (0=no pain - 10=worst possible pain experienced) and higher scores indicate a worse outcome~Pain scores, collected every 4 hours per hospital care standards, were averaged (post-operatively up to 48 hours) to obtain individual mean pain scores and a mean score for the group was then calculated." (NCT02543801)
Timeframe: Starting post operatively and then every four hours up to 48 hours
Intervention | score on a scale (Mean) |
---|
Hip Cohort Liposomal Bupivacaine | 3.78 |
Hip Cohort Ropivacaine | 3.85 |
Knee Cohort Liposomal Bupivacaine | 3.3 |
Knee Cohort Ropivacaine | 3.4 |
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Narcotic Use During Hospitalization
The amount of narcotic pain medication needed for patient to be comfortable. This is measured in morphine equivalents since there are many pain medications other than morphine. (NCT02570503)
Timeframe: 0-24 hours post surgery period, 24 - 48 hours post surgery period, and Full 48 hours post surgery period
Intervention | mg morphine equivalents (Mean) |
---|
| 0 to 24 hour post surgery period | 24 to 48 hour post surgery period | Full 48 hour post surgery period |
---|
Placebo | 72.3 | 72.8 | 145.7 |
,ROP/KET/CLON/EPI/SAL | 58.9 | 66.5 | 125.6 |
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Pain Score at 3-24 Hours
Visual Analog Scale 0-10; 0 = no pain, 10 = worst pain (NCT02658149)
Timeframe: measured once during time frame 3 hours-24 hours postoperative
Intervention | units on a scale (Mean) |
---|
Psoas Compartment Block | 1.9 |
Periarticular Local Anesthetic | 1.3 |
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Pain Score at 3 Hours
Visual Analog Scale 0-10; 0 = no pain, 10 = worst pain (NCT02658149)
Timeframe: 3 hours postoperative
Intervention | units on a scale (Mean) |
---|
Psoas Compartment Block | 4.0 |
Periarticular Local Anesthetic | 2.9 |
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Pain Score at 24-48 Hours
Visual Analog Scale 0-10; 0 = no pain, 10 = worst pain (NCT02658149)
Timeframe: measured once during time froma 24-48 hours postoperative
Intervention | units on a scale (Mean) |
---|
Psoas Compartment Block | 1.9 |
Periarticular Local Anesthetic | 1.7 |
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Opioid Usage In-hospital at 48 Hours
Total amount of opioids used per patient (measured with Morphine Equivalent Units) (NCT02658149)
Timeframe: 48 hours postoperatively
Intervention | Morphine Equivalent Units (Oral) (Mean) |
---|
Psoas Compartment Block | 22.3 |
Periarticular Local Anesthetic | 20.8 |
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Opioid Usage In-hospital at 24 Hours
Total amount of opioids used per patient (measured with Morphine Equivalent Units) (NCT02658149)
Timeframe: 24 hours postoperatively
Intervention | Morphine Equivalent Units (Oral) (Mean) |
---|
Psoas Compartment Block | 19.5 |
Periarticular Local Anesthetic | 16.7 |
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Oral Morphine Equivalents of Postoperative Opioid Requirements for 48 Hours
Total amounts of postoperative opioid requirements for 48 hours postoperatively (NCT02658240)
Timeframe: Postoperative 48 hours
Intervention | Oral Morphine Equivalent (mg) (Mean) |
---|
Compartment Block | 101.0 |
Infiltration | 115.6 |
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Postoperative Pain Score at Resting
The Visual Analog Pain Score (VAS) at resting on the scale of 10 (0= No pain, 10= Worst pain) at 48 hours postoperatively (NCT02658240)
Timeframe: Postoperative 48 hours
Intervention | units on a scale (Median) |
---|
Compartment Block | 1 |
Infiltration | 2 |
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Postoperative Pain Score With Movement
The Visual Analog Pain Score (VAS) with movement on the scale of 10 (0= No pain, 10= Worst pain) at 48 hours postoperatively (NCT02658240)
Timeframe: Postoperative 48 hours
Intervention | units on a scale (Mean) |
---|
Compartment Block | 3 |
Infiltration | 4 |
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The Time to Ambulation
The time to ambulation during 48 hours postoperative period (NCT02658240)
Timeframe: Postoperative 48 hours
Intervention | Hours (Median) |
---|
Compartment Block | 21.3 |
Infiltration | 22 |
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The Effect of Liposomal Bupivacaine on Average Postoperative Pain Levels on Postoperative Day 1.
Postoperative pain levels were determined with a numeric rating scale (NRS), rating pain from 0 - 10, where 0 = no pain, 10 = worst possible pain. Higher scores indicate a worse outcome. Pain levels were determined during routine vital signs every 4 hours post-operatively. (NCT02659501)
Timeframe: Average Pain Scores 24 hours Post-Operatively
Intervention | score on a scale (Mean) |
---|
Bupivacaine With Epinephrine Injections | 3.66 |
Liposomal Bupivacaine | 3.68 |
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The Effect of Liposomal Bupivacaine on Postoperative Opioid Consumption
Postoperative opioid consumption will be determined in each group. Opioid consumption post-operatively will be determined for patients in each group in standardized units of morphine milligram dosing equivalents per hour. (NCT02659501)
Timeframe: 24 hours
Intervention | Morphine equivalent dosage per hour (Mean) |
---|
Bupivacaine With Epinephrine Injections | 1.31 |
Liposomal Bupivacaine | .76 |
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The Effect of Liposomal Bupivacaine on Length of Hospital Stay
Length of hospital stay will be determined for patients in each group, in total hours. (NCT02659501)
Timeframe: 24-60 hours
Intervention | hrs (Mean) |
---|
Bupivacaine With Epinephrine Injections | 46.7 |
Liposomal Bupivacaine | 29.8 |
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The Effect of Liposomal Bupivacaine on Postoperative Diazepam Consumption
Benzodiazepine consumption, in mg of diazepam, was recorded for all patients and compared over the first 24 hours post-operatively. (NCT02659501)
Timeframe: 24 hours
Intervention | mg of diazepam/hr (Mean) |
---|
Bupivacaine With Epinephrine Injections | 0.35 |
Liposomal Bupivacaine | 0.18 |
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The Effect of Liposomal Bupivacaine on Antiemetic Consumption
The effect of liposomal bupivacaine on antiemetic consumption was assessed in mg of ondansetron consumed over first 24 hours post-operatively. (NCT02659501)
Timeframe: 24 hours
Intervention | mg of ondansetron (Mean) |
---|
Bupivacaine With Epinephrine Injections | 7.33 |
Liposomal Bupivacaine | 5.75 |
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Sensation in the Peroneal Nerve Distribution
Number of participants with self reported on a 3-point scale; 0=normal (No Sensory Block), 1= absent cold perception but touch sensation in tact (Partial Sensory Block), 2= absence of touch sensation (Complete Sensory Block) (NCT02701296)
Timeframe: Upon emergence from anesthesia in the PACU
Intervention | Participants (Count of Participants) |
---|
| Complete Sensory Block | Partial Sensory Block | No Sensory Block |
---|
Posterior Capsular Injection | 2 | 3 | 37 |
,Tibial Nerve Block | 1 | 11 | 24 |
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Pain Intensity
Mean Numeric Pain Rating Scale (NPRS) self-reported pain Intensity on a 11-point score (0=no pain to 10= worst possible) in Post Anesthesia Care Unit (PACU) and every 6 hours for 48 hours post surgery (NCT02701296)
Timeframe: 48 hours post surgery
Intervention | pain score (Mean) |
---|
| PACU Admission | PACU Discharge | 6th hour | 12th hour | 18th hour | 24th hour | 30th hour | 36th hour | 42nd hour | 48th hour |
---|
Posterior Capsular Injection | 3.5 | 2.1 | 1.9 | 2.0 | 2.3 | 2.7 | 2.6 | 2.5 | 3.2 | 2.5 |
,Tibial Nerve Block | 3.2 | 1.5 | 2.0 | 1.2 | 3.2 | 3.4 | 3.0 | 2.7 | 3.2 | 3.4 |
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Dorsiflexion in the Peroneal Nerve Distribution
Number of participants with a blinded nurse assessment on a 3-point scale 0= normal (No Motor Block), 1= weak (Partial Motor Block), 2 = absent (Complete Motor Block) (NCT02701296)
Timeframe: Upon emergence from anesthesia in the PACU
Intervention | Participants (Count of Participants) |
---|
| Complete Motor Block | Partial Motor Block | No Motor Block |
---|
Posterior Capsular Injection | 0 | 1 | 41 |
,Tibial Nerve Block | 0 | 4 | 32 |
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Cold Sensation in the Tibial Nerve Distribution
Number of participants with a self reported on a 3-point scale; 0=normal (No Sensory Block), 1= absent cold perception but touch sensation in tact (Partial Sensory Block), 2= absence of touch sensation (Complete Sensory Block) (NCT02701296)
Timeframe: Upon emergence from anesthesia in the PACU
Intervention | Participants (Count of Participants) |
---|
| Complete Sensory Block | Partial Sensory Block | No Sensory Block |
---|
Posterior Capsular Injection | 1 | 7 | 34 |
,Tibial Nerve Block | 6 | 27 | 3 |
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Opioid Consumption
Amount of opioid used for the first 24 hours post surgery (NCT02701296)
Timeframe: 24 hours post surgery
Intervention | mg (Mean) |
---|
Posterior Capsular Injection | 0.33 |
Tibial Nerve Block | 0.42 |
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Plantar Flexion in the Tibial Nerve Distribution
Blinded nurse assessment on a 3-point scale 0= normal (No Motor Block), 1= weak (Partial Motor Block), 2 = absent (Complete Motor Block) (NCT02701296)
Timeframe: Upon emergence from anesthesia in the PACU
Intervention | Participants (Count of Participants) |
---|
| Complete Motor Block | Partial Motor Block | No Motor Block |
---|
Posterior Capsular Injection | 1 | 3 | 38 |
,Tibial Nerve Block | 0 | 25 | 11 |
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Area Under Curve of MAP Below 65
Hypotension as measured by area under the curve of MAP less than 65. (NCT02701582)
Timeframe: 1 Day
Intervention | mmHG x minutes (Mean) |
---|
Goal Directed Therapy | -65.06 |
Control Group | -61.88 |
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Creatinine Change
Change in creatinine in the 72 hour post-op period (mg/dL) (NCT02701582)
Timeframe: Baseline and 72 hours
Intervention | mg/dL (Mean) |
---|
Goal Directed Therapy | -0.04 |
Control Group | -0.13 |
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Pulmonary Status as Measured by the Number of Participants Who Require Supplemental Oxygen
We looked at the number of patients who required supplemental oxygen within the first 24 hours after surgery. (NCT02701582)
Timeframe: 1 day
Intervention | Participants (Count of Participants) |
---|
Goal Directed Therapy | 17 |
Control Group | 25 |
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Patients Requiring Fluid Bolus for Management
Number of patients who received fluid boluses in the first 24 hours post-op (NCT02701582)
Timeframe: 1 day
Intervention | Participants (Count of Participants) |
---|
Goal Directed Therapy | 7 |
Control Group | 6 |
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Organ Oxygenation as Measured by Serum Lactate
Serum lactate levels, as measured in mmol/L, in patients during the first 24 hours after surgery. (NCT02701582)
Timeframe: Baseline and 24 Hours
Intervention | mmol/L (Mean) |
---|
Goal Directed Therapy | 2.0 |
Control Group | 1.75 |
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Organ Oxygenation as Measured by Arterial Blood Gas Values
Patient's organ oxygenation as measured by base deficit mEq/L, during the first 24 hours after surgery. (NCT02701582)
Timeframe: Baseline and 1 day
Intervention | mEq/L (Mean) |
---|
Goal Directed Therapy | 3.55 |
Control Group | 4.75 |
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Number of Patients Treated for Hypotension With Phenylephrine Drip
The number of patients on a phenylephrine drip within 24 hours post-op. (NCT02701582)
Timeframe: 1 day
Intervention | Participants (Count of Participants) |
---|
Goal Directed Therapy | 0 |
Control Group | 4 |
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Number of ICU Stays Greater Than 1.5 Days
the sum of ICU stays greater than the 1.5 Days eligibility for discharge from hospital according to the surgeon, over the course of 20 Days (NCT02701582)
Timeframe: 20 Days
Intervention | Number of ICU Stays greater that 1.5 Day (Number) |
---|
Goal Directed Therapy | 13 |
Control Group | 20 |
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Timing of Cardiovascular Drugs for MAP < 60 mmHg
Cardiovascular drugs as defined under interventions. Time of first administration of cardiovascular drug relative to the time at which the mean arterial pressure (MAP) drops below 60 mmHg. Per patient the average time to first administration of all hypotensive episodes was calculated. That average time is used as the outcome variable. A negative value indicates that administration occurred before the drop in MAP. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Intervention | minutes (Median) |
---|
Usual Care Group | 0.8 |
Hypotension Decision Support | 1.5 |
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Timing of Cardiovascular Drugs for MAP < 55 mmHg
Cardiovascular drugs as defined under interventions. Time of first administration of cardiovascular drug relative to the time at which the mean arterial pressure (MAP) drops below 55 mmHg. Per patient the average time to first administration of all hypotensive episodes was calculated. That average time is used as the outcome variable. A negative value indicates that administration occurred before the drop in MAP. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Intervention | minutes (Median) |
---|
Usual Care Group | 1 |
Hypotension Decision Support | 0.5 |
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Timing of Cardiovascular Drugs for MAP < 50 mmHg
Cardiovascular drugs as defined under interventions. Time of first administration of cardiovascular drug relative to the time at which the mean arterial pressure (MAP) drops below 50 mmHg. Per patient the average time to first administration of all hypotensive episodes was calculated. That average time is used as the outcome variable. A negative value indicates that administration occurred before the drop in MAP. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Intervention | minutes (Median) |
---|
Usual Care Group | 1 |
Hypotension Decision Support | 0 |
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Postoperative Rise in Creatinine Levels
Absolute values for serum creatinine before and after surgery will be compared. When multiple postoperative creatinine measurements are made, the maximum difference is reported. (NCT02726620)
Timeframe: Within 7 days after surgery
Intervention | mg/dL (Median) |
---|
Usual Care Group | 0.00 |
Hypotension Decision Support | 0.00 |
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Intravenous Anesthetic Drug Use During Intraoperative Hypotension: MAP < 65 mmHg
Average concentrations of propofol infusion rates during MAP < 65 mmHg episodes (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Intervention | mcg/kg/min (propofol) (Median) |
---|
Usual Care Group | 60.10 |
Hypotension Decision Support | 48.59 |
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Intravenous Anesthetic Drug Use During Intraoperative Hypotension: MAP < 60 mmHg
Average concentrations of propofol infusion rates during MAP < 60 mmHg episodes (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Intervention | mcg/kg/min (propofol) (Median) |
---|
Usual Care Group | 61.07 |
Hypotension Decision Support | 50.00 |
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Intravenous Anesthetic Drug Use During Intraoperative Hypotension: MAP < 55 mmHg
Average concentrations of propofol infusion rates during MAP < 55 mmHg episodes (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Intervention | mcg/kg/min (propofol) (Median) |
---|
Usual Care Group | 63.95 |
Hypotension Decision Support | 50.00 |
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Intraoperative Administration of Intravenous Fluids
Total amount (mL) of intravenous fluids (as defined under interventions) administered during the surgical procedure. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Intervention | mL (Median) |
---|
Usual Care Group | 1500.00 |
Hypotension Decision Support | 1400.00 |
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Incidence of a MAP < 60 mmHg for > 20 Minutes
Incidence of a mean arterial pressure (MAP) < 60 mmHg for a cumulative duration of all hypotensive episodes of more than 20 minutes during the anesthetic phase of the procedure. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Intervention | Participants (Count of Participants) |
---|
Usual Care Group | 3632 |
Hypotension Decision Support | 792 |
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Incidence of a MAP < 60 mmHg for > 10 Minutes
Incidence of a mean arterial pressure (MAP) < 60 mmHg for a cumulative duration of all hypotensive episodes of more than 10 minutes during the anesthetic phase of the procedure. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Intervention | Participants (Count of Participants) |
---|
Usual Care Group | 6989 |
Hypotension Decision Support | 1723 |
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Incidence of a MAP < 60 mmHg
Incidence of a mean arterial pressure (MAP) < 60 mmHg during anesthesia for 1 minute or more. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Intervention | Participants (Count of Participants) |
---|
Usual Care Group | 13779 |
Hypotension Decision Support | 3798 |
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Incidence of a MAP < 55 mmHg for > 20 Minutes
Incidence of a mean arterial pressure (MAP) < 55 mmHg for a cumulative duration of all hypotensive episodes of more than 20 minutes during the anesthetic phase of the procedure. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Intervention | Participants (Count of Participants) |
---|
Usual Care Group | 1223 |
Hypotension Decision Support | 284 |
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Incidence of a MAP < 55 mmHg for > 10 Minutes
Incidence of a mean arterial pressure (MAP) < 55 mmHg for a cumulative duration of all hypotensive episodes of more than 10 minutes during the anesthetic phase of the procedure. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Intervention | Participants (Count of Participants) |
---|
Usual Care Group | 3181 |
Hypotension Decision Support | 759 |
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Incidence of a MAP < 55 mmHg
Incidence of a mean arterial pressure (MAP) < 55 mmHg during anesthesia for 1 minute or more. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Intervention | Participants (Count of Participants) |
---|
Usual Care Group | 10991 |
Hypotension Decision Support | 3045 |
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Incidence of a MAP < 50 mmHg for > 20 Minutes
Incidence of a mean arterial pressure (MAP) < 50 mmHg for a cumulative duration of all hypotensive episodes of more than 20 minutes during the anesthetic phase of the procedure. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Intervention | Participants (Count of Participants) |
---|
Usual Care Group | 304 |
Hypotension Decision Support | 85 |
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Time to Discharge Readiness at the Postanesthesia Care Unit (PACU)
The time from arriving at the postanesthesia care unit (PACU) until the time the patient is considered ready for discharge (in minutes). (NCT02726620)
Timeframe: A specific time frame on the day of surgery: from the start of admission to the PACU to discharge from the PACU, an expected average of 4 hours
Intervention | minutes (Median) |
---|
Usual Care Group | 67 |
Hypotension Decision Support | 60 |
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Incidence of a MAP < 50 mmHg for > 10 Minutes
Incidence of a mean arterial pressure (MAP) < 50 mmHg for a cumulative duration of all hypotensive episodes of more than 10 minutes during the anesthetic phase of the procedure. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Intervention | Participants (Count of Participants) |
---|
Usual Care Group | 1159 |
Hypotension Decision Support | 326 |
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Incidence of a MAP < 50 mmHg
Incidence of a mean arterial pressure (MAP) < 50 mmHg during anesthesia for 1 minute or more. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Intervention | Participants (Count of Participants) |
---|
Usual Care Group | 7781 |
Hypotension Decision Support | 2196 |
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In-hospital Mortality
Hospital mortality rate during a single hospital admission after the surgery (NCT02726620)
Timeframe: All postoperative days during a single hospital admission, expected median of 5 days
Intervention | Participants (Count of Participants) |
---|
Usual Care Group | 487 |
Hypotension Decision Support | 137 |
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Estimated Intraoperative Blood Loss
The estimated blood loss in mL during the surgical procedure (NCT02726620)
Timeframe: During the surgical procedure: an expected average of 2 hours
Intervention | mL (Median) |
---|
Usual Care Group | 100 |
Hypotension Decision Support | 75 |
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Depth and Duration of Intraoperative Hypotension - Threshold MAP 75 mmHg
Depth and duration of intraoperative hypotension will be modeled by calculating areas under the threshold for mean arterial pressures (MAPs). Thresholds will vary from 75 mmHg to 50 mmHg in 5 mmHg decrements. Together these variables represent the depth and duration of intraoperative hypotension. To optimize goodness of fit of these variables, the decremental steps may be increased to 10 mmHg and more restrictive lowest and highest thresholds may be chosen for the statistical analysis. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Intervention | mmHg*minute (Median) |
---|
Usual Care Group | 485 |
Hypotension Decision Support | 417 |
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Depth and Duration of Intraoperative Hypotension - Threshold MAP 70 mmHg
Depth and duration of intraoperative hypotension will be modeled by calculating areas under the threshold for mean arterial pressures (MAPs). Thresholds will vary from 75 mmHg to 50 mmHg in 5 mmHg decrements. Together these variables represent the depth and duration of intraoperative hypotension. To optimize goodness of fit of these variables, the decremental steps may be increased to 10 mmHg and more restrictive lowest and highest thresholds may be chosen for the statistical analysis. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Intervention | mmHg*minute (Median) |
---|
Usual Care Group | 273 |
Hypotension Decision Support | 235 |
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Depth and Duration of Intraoperative Hypotension - Threshold MAP 65 mmHg
Depth and duration of intraoperative hypotension will be modeled by calculating areas under the threshold for mean arterial pressures (MAPs). Thresholds will vary from 75 mmHg to 50 mmHg in 5 mmHg decrements. Together these variables represent the depth and duration of intraoperative hypotension. To optimize goodness of fit of these variables, the decremental steps may be increased to 10 mmHg and more restrictive lowest and highest thresholds may be chosen for the statistical analysis. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Intervention | mmHg*minute (Median) |
---|
Usual Care Group | 96 |
Hypotension Decision Support | 86 |
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Depth and Duration of Intraoperative Hypotension - Threshold MAP 60 mmHg
Depth and duration of intraoperative hypotension will be modeled by calculating areas under the threshold for mean arterial pressures (MAPs). Thresholds will vary from 75 mmHg to 50 mmHg in 5 mmHg decrements. Together these variables represent the depth and duration of intraoperative hypotension. To optimize goodness of fit of these variables, the decremental steps may be increased to 10 mmHg and more restrictive lowest and highest thresholds may be chosen for the statistical analysis. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Intervention | mmHg*minute (Median) |
---|
Usual Care Group | 57 |
Hypotension Decision Support | 52 |
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Depth and Duration of Intraoperative Hypotension - Threshold MAP 55 mmHg
Depth and duration of intraoperative hypotension will be modeled by calculating areas under the threshold for mean arterial pressures (MAPs). Thresholds will vary from 75 mmHg to 50 mmHg in 5 mmHg decrements. Together these variables represent the depth and duration of intraoperative hypotension. To optimize goodness of fit of these variables, the decremental steps may be increased to 10 mmHg and more restrictive lowest and highest thresholds may be chosen for the statistical analysis. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Intervention | mmHg*minute (Median) |
---|
Usual Care Group | 23 |
Hypotension Decision Support | 23 |
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Average Use of Cardiovascular Drugs: Glycopyrrolate
Cardiovascular drugs as defined under interventions. Average use for each drug will be calculated. Cardiovascular drugs that were given in <1% of cases are not reported, as the average dosage would be meaningless. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Intervention | mg (Median) |
---|
Usual Care Group | 0.40 |
Hypotension Decision Support | 0.40 |
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Depth and Duration of Intraoperative Hypotension - Threshold MAP 50 mmHg
Depth and duration of intraoperative hypotension will be modeled by calculating areas under the threshold for mean arterial pressures (MAPs). Thresholds will vary from 75 mmHg to 50 mmHg in 5 mmHg decrements. Together these variables represent the depth and duration of intraoperative hypotension. To optimize goodness of fit of these variables, the decremental steps may be increased to 10 mmHg and more restrictive lowest and highest thresholds may be chosen for the statistical analysis. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Intervention | mmHg*minute (Median) |
---|
Usual Care Group | 19 |
Hypotension Decision Support | 19 |
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Average Use of Cardiovascular Drugs: Phenylephrine
Cardiovascular drugs as defined under interventions. Average use for each drug will be calculated. Cardiovascular drugs that were given in <1% of cases are not reported, as the average dosage would be meaningless. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Intervention | mg (Median) |
---|
Usual Care Group | 0.90 |
Hypotension Decision Support | 1.30 |
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Average Use of Cardiovascular Drugs: Norepinephrine
Cardiovascular drugs as defined under interventions. Average use for each drug will be calculated. Cardiovascular drugs that were given in <1% of cases are not reported, as the average dosage would be meaningless. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Intervention | mg (Median) |
---|
Usual Care Group | 0.62 |
Hypotension Decision Support | 0.70 |
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Average Use of Cardiovascular Drugs: Epinephrine
Cardiovascular drugs as defined under interventions. Average use for each drug will be calculated. Cardiovascular drugs that were given in <1% of cases are not reported, as the average dosage would be meaningless. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Intervention | mg (Median) |
---|
Usual Care Group | 1.00 |
Hypotension Decision Support | 0.70 |
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Average Use of Cardiovascular Drugs: Ephedrine
Cardiovascular drugs as defined under interventions. Average use for each drug will be calculated. Cardiovascular drugs that were given in <1% of cases are not reported, as the average dosages would be meaningless. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Intervention | mg (Median) |
---|
Usual Care Group | 20 |
Hypotension Decision Support | 15 |
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30-day Mortality
Vanderbilt University Medical Center: combination of in-hospital mortality and 'alive-index' (which checks for visits to the hospital in the electronic healthcare record as indication of being alive at 30 days) (NCT02726620)
Timeframe: 30 days after surgery
Intervention | Participants (Count of Participants) |
---|
Usual Care Group | 511 |
Hypotension Decision Support | 143 |
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Intravenous Anesthetic Drug Use During Intraoperative Hypotension: MAP < 50 mmHg
Average concentrations of propofol infusion rates during MAP < 50 mmHg episodes (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Intervention | mcg/kg/min (propofol) (Median) |
---|
Usual Care Group | 65.00 |
Hypotension Decision Support | 50.00 |
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Inhaled Anesthetic Drug Use During Intraoperative Hypotension: MAP < 65 mmHg
Average concentrations of inhalational anesthesia during MAP < 65 mmHg episodes (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Intervention | EndTidal% (other) (Median) |
---|
| Sevoflurane (EndTidal %) | Isoflurane (EndTidal %) | Desflurane (EndTidal %) |
---|
Hypotension Decision Support | 1.27 | 0.68 | 2.31 |
,Usual Care Group | 1.35 | 0.68 | 4.10 |
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Inhaled Anesthetic Drug Use During Intraoperative Hypotension: MAP < 60 mmHg
Average concentrations of inhalational anesthesia during MAP < 60 mmHg episodes (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Intervention | EndTidal% (other) (Median) |
---|
| Sevoflurane (EndTidal %) | Isoflurane (EndTidal %) | Desflurane (EndTidal %) |
---|
Hypotension Decision Support | 1.25 | 0.67 | 2.33 |
,Usual Care Group | 1.35 | 0.68 | 4.36 |
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Inhaled Anesthetic Drug Use During Intraoperative Hypotension: MAP < 55 mmHg
Average concentrations of inhalational anesthesia during MAP < 55 mmHg episodes (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Intervention | EndTidal% (other) (Median) |
---|
| Sevoflurane (EndTidal %) | Isoflurane (EndTidal %) | Desflurane (EndTidal %) |
---|
Hypotension Decision Support | 1.25 | 0.67 | 4.65 |
,Usual Care Group | 1.34 | 0.68 | 4.60 |
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Inhaled Anesthetic Drug Use During Intraoperative Hypotension: MAP < 50 mmHg
Average concentrations of inhalational anesthesia during MAP < 50 mmHg episodes (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Intervention | EndTidal% (other) (Median) |
---|
| Sevoflurane (EndTidal %) | Isoflurane (EndTidal %) | Desflurane (EndTidal %) |
---|
Hypotension Decision Support | 1.23 | 0.65 | 4.70 |
,Usual Care Group | 1.32 | 0.65 | 4.28 |
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Usage Frequency of Cardiovascular Drugs: Phenylephrine
Cardiovascular drugs as defined under interventions. Frequency of patients receiving the drug. Cardiovascular drugs that were given in <1% of cases are not reported. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Intervention | Participants (Count of Participants) |
---|
Usual Care Group | 12211 |
Hypotension Decision Support | 3685 |
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Usage Frequency of Cardiovascular Drugs: Norepinephrine
Cardiovascular drugs as defined under interventions. Frequency of patients receiving the drug. Cardiovascular drugs that were given in <1% of cases are not reported. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Intervention | Participants (Count of Participants) |
---|
Usual Care Group | 762 |
Hypotension Decision Support | 233 |
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Usage Frequency of Cardiovascular Drugs: Glycopyrrolate
Cardiovascular drugs as defined under interventions. Frequency of patients receiving the drug. Cardiovascular drugs that were given in <1% of cases are not reported. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Intervention | Participants (Count of Participants) |
---|
Usual Care Group | 11093 |
Hypotension Decision Support | 1257 |
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Usage Frequency of Cardiovascular Drugs: Ephinephrine
Cardiovascular drugs as defined under interventions. Frequency of patients receiving the drug. Cardiovascular drugs that were given in <1% of cases are not reported. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Intervention | Participants (Count of Participants) |
---|
Usual Care Group | 1215 |
Hypotension Decision Support | 409 |
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Usage Frequency of Cardiovascular Drugs: Ephedrine
Cardiovascular drugs as defined under interventions. Frequency of patients receiving the drug. Cardiovascular drugs that were given in <1% of cases are not reported. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Intervention | Participants (Count of Participants) |
---|
Usual Care Group | 9310 |
Hypotension Decision Support | 2718 |
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Timing of Cardiovascular Drugs for MAP < 65 mmHg
Cardiovascular drugs as defined under interventions. Time of first administration of cardiovascular drug relative to the time at which the mean arterial pressure (MAP) drops below 60 mmHg. Per patient the average time to first administration of all hypotensive episodes was calculated. That average time is used as the outcome variable. A negative value indicates that administration occurred before the drop in MAP. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Intervention | minutes (Median) |
---|
Usual Care Group | 2 |
Hypotension Decision Support | 1.14 |
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Post-operative Pain the First 24hrs
To determine whether the use of a CNB in patients undergoing penile prosthesis surgery results in decreased immediate postoperative pain in the first 24 hours after surgery compared with patients having only general anesthesia as determined by postop pain score. The mean, median and max pain will be assessed using the numeric rating scale (NRS). The NRS is scored by numeric integers, 0 through 10. The NRS will be used verbally. Numerical Rating Scale (NRS), patients are asked to circle the number between 0 and 10 that fits best to their pain intensity. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible' (NCT02740127)
Timeframe: 24 hours
Intervention | score on a scale (Mean) |
---|
| Min Pain within 24hrs | Median Pain within 24 hrs | Max Pain within 24 hrs |
---|
General Anesthesia and Caudal Nerve Block | 1.1667 | 3.0833 | 6.125 |
,General Anesthesia Only | 0.9286 | 3.7143 | 6.7857 |
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Post-Operative Pain Medication Usage in Post Anesthesia Care Unit (PACU)
Pain evaluated by the amount of intravenous and oral pain medicine administered in the first 24 hours post-operatively. Pain assessed using the numeric rating scale (NRS). The NRS is scored by numeric integers, 0 through 10, where 0 is no pain and 10 is the worst pain. (NCT02740127)
Timeframe: 24 hours
Intervention | mg (Mean) |
---|
General Anesthesia and Caudal Nerve Block | 13.0208 |
General Anesthesia Only | 15.1786 |
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Length of Hospital Stay
To determine whether the use of a CNB in patients undergoing penile prosthesis surgery results in a decreased length of hospital stay compared with patients having only general anesthesia. (NCT02740127)
Timeframe: 32 Hours
Intervention | Hours (Mean) |
---|
General Anesthesia and Caudal Nerve Block | 24.8424 |
General Anesthesia Only | 24.9506 |
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Percentage of Participants With Episodes of Nausea or Vomiting
Any episodes during the first 24 hours will be recorded as a yes. (NCT02741713)
Timeframe: Assessed 24hrs post-block (yes/no)
Intervention | percentage of participants (Number) |
---|
Interscalene Block Plus Sham Block | 39 |
Interscalene Plus PECS Blocks | 37 |
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Post-operative Axillary Pain
Post-operative ambulatory surgery subjects will be asked 6 hours after block placement about the presence of axillary pain at rest. Numerical Rating Scale scores (0-10) will be recorded with 0= no pain, 10=most pain possible. Higher scores denotes worse outcome. (NCT02741713)
Timeframe: 6 hours post-block.
Intervention | units on a scale (Median) |
---|
Interscalene Block Plus Sham Block | 3 |
Interscalene Plus PECS Blocks | 0 |
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Time From Block Placement to Onset of Axillary Pain
Time self-reported by patients in the Interscalene Plus PECS Blocks group during data collection phone call at 24 hours post-block. (NCT02741713)
Timeframe: Assessed 24hrs post-block in hours
Intervention | Hours (Mean) |
---|
Interscalene Plus PECS Blocks | 16.7 |
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Total Opioid Usage
Recorded in oxycodone equivalents in the first 24 hours post-discharge from the PACU. (NCT02741713)
Timeframe: Assessed 24hrs post-block in mg
Intervention | mg (Mean) |
---|
Interscalene Block Plus Sham Block | 31.6 |
Interscalene Plus PECS Blocks | 26.9 |
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Numerical Rating Scale Pain Scores (0-10) at Rest
Subjects were asked about their overall shoulder pain during the followup phone call at 24hrs post-block. Numerical Rating Scale scores (0-10) will be recorded with 0= no pain, 10=most pain possible. Higher scores denotes worse outcome. (NCT02741713)
Timeframe: Assessed 24hrs post-block on a scale from 0-10.
Intervention | units on a scale (Median) |
---|
Interscalene Block Plus Sham Block | 6 |
Interscalene Plus PECS Blocks | 6 |
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Total Narcotic Consumption
Parenteral and oral narcotic agents will be utilized by patients for post-operative pain control per the standard of care. No alterations in narcotic prescription behavior will be observed for this study. (NCT02793947)
Timeframe: Narcotic consumption will be recorded every 8 hours for the first two post-operative days.
Intervention | mg of morphine (Mean) |
---|
Peri-incisional Injection | 5.0 |
Control (no Injection) | 9.7 |
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Visual Analog Scale Pain Assessment
"Patients will describe their current level of comfort on a 10 point scale while at rest. Zero corresponds to no pain and ten corresponds to the most extreme possible pain. Visual analog scores will be collected by nursing staff who are blinded to the treatment allocation." (NCT02793947)
Timeframe: Pain assessment will be collected immediately prior to surgery (pre-op), immediately following surgery in the post-anesthesia care unit (PACU), and every 4 hours following surgery for the first two post-operative days (48 hours total; 4H-48H)
Intervention | units on a scale (Median) |
---|
| Pre-op | PACU | 4H | 8H | 12H | 16H | 20H | 24H | 28H | 32H | 36H | 40H | 44H | 48H |
---|
Control (no Injection) | 5.0 | 3.2 | 5.0 | 5.0 | 5.0 | 4.0 | 4.0 | 4.0 | 3.5 | 5.0 | 4.0 | 3.5 | 4.0 | 3.0 |
,Peri-incisional Injection | 5.0 | 1.6 | 1.0 | 2.0 | 3.5 | 3.5 | 4.0 | 3.0 | 3.0 | 3.0 | 4.0 | 3.0 | 3.0 | 3.0 |
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Maximum Intraoperative Change in Pupil Diameter
This is the maximum observed change in pupil diameter, as measured compared to baseline. (NCT02895035)
Timeframe: During cataract surgery, with maximum end time of 20 minutes
Intervention | millimeters (Mean) |
---|
Epinephrine | -0.71 |
Omidria | -0.66 |
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Number of Eyes With Pupil Diameter Less Than 6 mm During Cortical Clean-up
Number of eyes with a measured pupil diameter less than 6 mm during cortical clean-up (NCT02895035)
Timeframe: During cataract surgery, cortical clean-up stage, up to 5 mins
Intervention | Eyes (Count of Units) |
---|
Epinephrine | 3 |
Omidria | 2 |
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Number of Eyes With Pupil Diameter Less Than 6 mm at Any Time During Surgery
Number of eyes with a measured pupil diameter less than 6 mm at any time during surgery (NCT02895035)
Timeframe: During cataract surgery, with maximum end time of 20 minutes
Intervention | Eyes (Count of Units) |
---|
Epinephrine | 3 |
Omidria | 2 |
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Mean Area Under the Curve Change From Baseline in Pupil Diameter Over Time to the End of Cataract Surgery
Mean area under the curve was calculated by assessing the pupil diameter at baseline and then again at 1 minute intervals until the surgery was complete (max 20 minutes). Units are in millimeters*seconds (NCT02895035)
Timeframe: During cataract surgery, with maximum end time of 20 minutes
Intervention | millimeters * seconds (Mean) |
---|
Epinephrine | 1.76 |
Omidria | 0.8 |
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Pupil Size Upon Completion of Surgery
(NCT02909140)
Timeframe: intraoperative
Intervention | mm (Number) |
---|
Intracameral Mydriasis | 7 |
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Percentage of Patients in Each Arm That Required Another Mydriatic Agent
(NCT02909140)
Timeframe: intraoperative
Intervention | percent of participants (Number) |
---|
Intracameral Mydriasis | 0 |
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Cumulative Energy Dispersed for Each Arm
The amount of energy needed to break up the cataractous lens (NCT02909140)
Timeframe: During cataract surgery
Intervention | Percent-seconds (Number) |
---|
Intracameral Mydriasis | 6.6 |
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Percentage of Patients in Each Arm That Required Use of an Iris Expansion Device During the Procedure
(NCT02909140)
Timeframe: intraoperative
Intervention | percent (Number) |
---|
Intracameral Mydriasis | 50 |
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Opioid Use in First 24 Hours Post-surgery
Total opioid consumption expressed in morphine equivalent dose will be recorded, including IV and oral opioids, in the first 24 hours post-surgery. (NCT02967172)
Timeframe: At 24 hours post-surgery & during the total time of inpatient stay to dischage
Intervention | Milligrams (Median) |
---|
| Opioid use 24hr post-surgery | Total inpatient opioid use |
---|
Control | 28.3 | 32.7 |
,Peri-incisional Injection | 25.5 | 29.0 |
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Change in Post-operative Visual Analog Pain Scores (VAS)
The primary outcome was VAS pain over the first 48 hours postoperatively. Patients reported pain with use of a 100-mm VAS, with 0-mm being no pain and 100-mm being the most extreme pain imaginable. A higher score indicates worse pain. Scores were reported as mean values at 24 hours post-surgery and 48 hours post-surgery. (NCT02967172)
Timeframe: Immediately following surgery, then every 4 hours following surgery for 48 hours post-surgery.
Intervention | 0 to 100 score on a scale (Mean) |
---|
| Mean VAS score 24hr post-op | Mean VAS score 48hr post-op |
---|
Control | 52 | 50 |
,Peri-incisional Injection | 42 | 41 |
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Post-operative Length of Stay
Number of days in the hospital following surgery (NCT02967172)
Timeframe: From immediately following surgery to 90 days after.
Intervention | Hours (Median) |
---|
Peri-incisional Injection | 22.3 |
Control | 22.5 |
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Patients Returning Home Following Surgery
Number of patients returning to their home following discharge, vs. going to a rehabilitation or skilled nursing facility (NCT02967172)
Timeframe: Following hospital discharge from surgery
Intervention | Participants (Count of Participants) |
---|
Peri-incisional Injection | 49 |
Control | 46 |
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Patients Satisfaction
Patient's satisfaction was recorded using a score ranging from 0 for not satisfied to 10 for totally satisfied. (NCT02988050)
Timeframe: 1 hour after the operation
Intervention | score on a scale (Mean) |
---|
Conscious sedation1 | 6.33 |
Conscious sedation2 | 6.45 |
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The Prevention of Cardiac Arrhythmias Occurence by Epidural Anesthesia Added to General Anesthesia Evaluated by a Number and Type of Arrhythmias Observed
The investigator evaluates the incidence of cardiac arrhythmias depending on anesthesia method by observing the number and type of arrhythmias and whether additional interventions were needed to treat them (NCT02988219)
Timeframe: 60 months
Intervention | Participants (Count of Participants) |
---|
| arrhythmia before surgery72559413 | arrhythmia before surgery72559414 | arrhythmia during surgery72559413 | arrhythmia during surgery72559414 | arrhythmia after surgery72559413 | arrhythmia after surgery72559414 | QTc long > 0.45s before surgery72559413 | QTc long > 0.45s before surgery72559414 | QTc long > 0.45s during surgery72559413 | QTc long > 0.45s during surgery72559414 | QTc long > 0.45s after surgery72559413 | QTc long > 0.45s after surgery72559414 | QTc long > 0.45s in the perioperative time72559413 | QTc long > 0.45s in the perioperative time72559414 | Additional intervention needed72559414 | Additional intervention needed72559413 |
---|
| observed | not observed |
---|
General Anesthesia (G) | 3 |
Combined General/Epidural (G/E) | 4 |
General Anesthesia (G) | 21 |
Combined General/Epidural (G/E) | 18 |
Combined General/Epidural (G/E) | 12 |
Combined General/Epidural (G/E) | 10 |
General Anesthesia (G) | 8 |
Combined General/Epidural (G/E) | 6 |
General Anesthesia (G) | 16 |
Combined General/Epidural (G/E) | 16 |
Combined General/Epidural (G/E) | 2 |
Combined General/Epidural (G/E) | 20 |
General Anesthesia (G) | 1 |
General Anesthesia (G) | 23 |
Combined General/Epidural (G/E) | 8 |
Combined General/Epidural (G/E) | 14 |
General Anesthesia (G) | 0 |
Combined General/Epidural (G/E) | 0 |
General Anesthesia (G) | 24 |
Combined General/Epidural (G/E) | 22 |
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Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative Period
"The investigator evaluates the incidence of cardiac arrhythmias, the type of arrhythmias and whether additional interventions were needed to treat them~Arrhythmias observed:~tachycardia >100 bpm bradycardia < 50 bpm pause (P-P interval > 2 seconds) ventricular extrasystoles (VE) > 1000/ 24 hours supraventricular extrasystoles (SVE) >200/24 hours" (NCT02988219)
Timeframe: 60 months
Intervention | Participants (Count of Participants) |
---|
| Tachycardia < 140 bpm before surgery72559413 | Tachycardia < 140 bpm before surgery72559414 | Tachycardia < 140 bpm during surgery72559414 | Tachycardia < 140 bpm during surgery72559413 | Tachycardia < 140 bpm after surgery72559413 | Tachycardia < 140 bpm after surgery72559414 | Bradycardia before surgery72559414 | Bradycardia before surgery72559413 | Bradycardia during surgery72559414 | Bradycardia during surgery72559413 | Bradycardia after surgery72559413 | Bradycardia after surgery72559414 | Bradycardia in the perioperative period72559414 | Bradycardia in the perioperative period72559413 | pause > 2s before surgery72559413 | pause > 2s before surgery72559414 | pause > 2s during surgery72559414 | pause > 2s during surgery72559413 | pause > 2s after surgery72559414 | pause > 2s after surgery72559413 | pause > 2s in the perioperative period72559414 | pause > 2s in the perioperative period72559413 | SVE before surgery72559413 | SVE before surgery72559414 | SVE during surgery72559413 | SVE during surgery72559414 | SVE after surgery72559414 | SVE after surgery72559413 | SVE in the perioperativ72559413 | SVE in the perioperativ72559414 | VE before surgery72559414 | VE before surgery72559413 | VE during surgery72559413 | VE during surgery72559414 | VE after surgery72559413 | VE after surgery72559414 | VE in the perioperative period72559413 | VE in the perioperative period72559414 | Additional intervention needed72559413 | Additional intervention needed72559414 |
---|
| observed | not observed |
---|
Combined General/Epidural (G/E) | 6 |
General Anesthesia (G) | 18 |
Combined General/Epidural (G/E) | 16 |
General Anesthesia (G) | 2 |
Combined General/Epidural (G/E) | 5 |
General Anesthesia (G) | 22 |
Combined General/Epidural (G/E) | 17 |
General Anesthesia (G) | 5 |
General Anesthesia (G) | 19 |
Combined General/Epidural (G/E) | 3 |
Combined General/Epidural (G/E) | 19 |
General Anesthesia (G) | 14 |
Combined General/Epidural (G/E) | 10 |
General Anesthesia (G) | 10 |
Combined General/Epidural (G/E) | 12 |
General Anesthesia (G) | 6 |
Combined General/Epidural (G/E) | 4 |
Combined General/Epidural (G/E) | 18 |
General Anesthesia (G) | 16 |
Combined General/Epidural (G/E) | 11 |
General Anesthesia (G) | 8 |
General Anesthesia (G) | 0 |
General Anesthesia (G) | 24 |
Combined General/Epidural (G/E) | 2 |
Combined General/Epidural (G/E) | 20 |
Combined General/Epidural (G/E) | 1 |
Combined General/Epidural (G/E) | 21 |
General Anesthesia (G) | 1 |
General Anesthesia (G) | 23 |
General Anesthesia (G) | 3 |
General Anesthesia (G) | 21 |
Combined General/Epidural (G/E) | 0 |
Combined General/Epidural (G/E) | 22 |
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Change in Patient-reported Visual Analog Scale (VAS) Pain Intensity Score
Patient-reported VAS pain intensity score (0 = no pain, 10 = worst pain possible) will be collected. Mean VAS scores for the 72-hour period were calculated using the cohort's reported average pain scores at each 12-hour interval. (NCT03001453)
Timeframe: 72 hours post-operation, divided into six 12-hour periods
Intervention | units on a scale (Mean) |
---|
Liposomal Bupivacaine | 3.8 |
Bupivacaine With Epinephrine | 3.7 |
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Number of Patients That Experienced a Fall
(NCT03001453)
Timeframe: 72 hours postoperation
Intervention | participants (Number) |
---|
Liposomal Bupivacaine | 0 |
Bupivacaine With Epinephrine | 0 |
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Length of Stay (LOS, in Days)
(NCT03001453)
Timeframe: From time of surgery until patient is discharged, an average of 1.5 days.
Intervention | Hours (Mean) |
---|
Liposomal Bupivacaine | 46.0 |
Bupivacaine With Epinephrine | 44.4 |
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Patient Morphine Equivalent Consumption
All opioid doses were administered to the patient at 12-hour intervals post-surgery. Doses were recorded till either of the following criteria was met, the patient was discharged or the 72-hour post-surgery timeframe ended. The doses were then collected and converted to OMEs, in milligrams. (NCT03001453)
Timeframe: 72 hours postoperation, divided into six 12-hour periods
Intervention | mg (Mean) |
---|
| 0-12 | 12-24 | 24-36 | 36-48 | 48-60 | 60-72 | Total |
---|
Bupivacaine With Epinephrine | 50.5 | 29.6 | 21.0 | 27.4 | 15.4 | 20.7 | 121.2 |
,Liposomal Bupivacaine | 35.1 | 28.0 | 16.8 | 20.6 | 23.7 | 20.9 | 100.3 |
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Time to Ambulation More Than 20 Feet (in Hours)
The length of time (in hours) until the patient first ambulates more than 20 feet from the time of surgery will be recorded. (NCT03001453)
Timeframe: from time of surgery until patient first ambulates more than 20 feet or 72 hours post-surgery or patient discharge, whichever comes first
Intervention | hours (Mean) |
---|
Liposomal Bupivacaine | 10.9 |
Bupivacaine With Epinephrine | 14.0 |
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Post-operative Verbal Pain Score at Rest
Assessed on an 11 point (0-10) numeric analog scale with a higher score denoting a worse outcome (NCT03007966)
Timeframe: 24 hrs Post Nerve Block
Intervention | score on a scale (Mean) |
---|
Ilioinguinal / Iliohypogastric Block | 3 |
Quadratus Lumborum Block | 2.7 |
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Post-operative Verbal Pain Score With Activity
Assessed on an 11 point (0-10) numeric analog scale with a higher score denoting a worse outcome (NCT03007966)
Timeframe: 24hrs Post Nerve Block
Intervention | score on a scale (Mean) |
---|
Ilioinguinal / Iliohypogastric Block | 4.9 |
Quadratus Lumborum Block | 5.3 |
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Post-operative Verbal Pain Score With Movement
Assessed on an 11-point (0-10) numeric analog scale with a higher score denoting a worse outcome. (NCT03007966)
Timeframe: 8 hrs Post Nerve Block
Intervention | score on a scale (Mean) |
---|
Ilioinguinal / Iliohypogastric Block | 5.10 |
Quadratus Lumborum Block | 5.03 |
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Time to First Oral Analgesic
When does the patient require their first post operative analgesic dose? (NCT03007966)
Timeframe: 24hrs Post Nerve Block
Intervention | minutes (Median) |
---|
Ilioinguinal / Iliohypogastric Block | 141 |
Quadratus Lumborum Block | 91 |
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Total Opioid Consumption
Total opioids consumed during the first 24hrs post operatively. Measured as 24hr Oxycodone Equivalent (NCT03007966)
Timeframe: 24 hrs Post Nerve Block
Intervention | milligrams (Mean) |
---|
Ilioinguinal / Iliohypogastric Block | 19.7 |
Quadratus Lumborum Block | 25.2 |
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Post-operative Verbal Pain Score at Rest
Assessed on an 11-point (0-10) numeric analog scale with a higher score denoting a worse outcome (NCT03007966)
Timeframe: 8 hrs Post Nerve Block
Intervention | score on a scale (Mean) |
---|
Ilioinguinal / Iliohypogastric Block | 3.6 |
Quadratus Lumborum Block | 3.3 |
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Mean Total Postoperative Opioid Consumption (in Morphine Equivalents)
(NCT03011333)
Timeframe: 72 Hours
Intervention | Morphine milligram equivalents (MME) (Mean) |
---|
Group 1: HTX-011 | 38.71 |
Group 2: HTX-011 | 24.39 |
Group 3: HTX-011 | 38.00 |
Group 4: HTX-011 | 28.84 |
Group 5: HTX-011 | 37.46 |
Group 6: Bupivacaine HCl | 33.57 |
Group 7: Saline Placebo | 36.38 |
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Mean Area Under the Curve (AUC) of the NRS-A (Windowed Worst Observation Carried Forward) Pain Intensity Scores
"Pain intensity scores are assessed using an 11-point Numeric Rating Scale (NRS) (0-10) where 0 represents no pain and 10 represents worst pain imaginable. NRS scores are recorded with activity (NRS-A), raising the hands above the head (with wrists above the crown of the head) for at least 5 seconds." (NCT03011333)
Timeframe: 24 hours
Intervention | pain intensity score*hr (Mean) |
---|
Group 1: HTX-011 | 124.51 |
Group 2: HTX-011 | 136.17 |
Group 3: HTX-011 | 136.76 |
Group 4: HTX-011 | 116.71 |
Group 5: HTX-011 | 114.87 |
Group 6: Bupivacaine HCl | 133.83 |
Group 7: Saline Placebo | 151.52 |
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72-hour Cumulative Amount of Intravenous Fluid (mL) After Treatment
Cumulative amount of intravenous fluid (mL) during the first 72 hours after treatment. (NCT03020407)
Timeframe: 72 hours after treatment
Intervention | mL (Mean) |
---|
IVC Ultrasound-guided | 7,300 |
Usual Care | 7,702 |
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Change in Sequential Organ Failure Assessment (SOFA) Score in 72 Hours After Treatment
The change in Sequential Organ Failure Assessment (SOFA) score between the score at initial presentation and 72 hours after treatment, determined by SOFA score at presentation minus the SOFA score at 72 hours after treatment. The possible minimum and maximum value of the change in SOFA score are -24 and +24, respectively. The higher value means the more relative reduction in SOFA score at 72 hours and indicates a better clinical outcome. (NCT03020407)
Timeframe: 72 hours after treatment
Intervention | Score on a scale (Median) |
---|
IVC Ultrasound-guided | 1 |
Usual Care | 1 |
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30-day Mortality
30-day mortality related to septic shock (NCT03020407)
Timeframe: 30 day after randomization
Intervention | Participants (Count of Participants) |
---|
IVC Ultrasound-guided | 20 |
Usual Care | 19 |
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6-hour Cumulative Amount of Intravenous Fluid (mL)
Cumulative amount of intravenous fluid (mL) during the first 6 hours after treatment. (NCT03020407)
Timeframe: 6 hours after treatment
Intervention | mL (Median) |
---|
IVC Ultrasound-guided | 1900 |
Usual Care | 2600 |
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Percentage Change of 6-hour Lactate
The percentage change in blood lactate at 6 hour after initiation of treatment, calculated by [(Initial blood lactate level at presentation - blood lactate level at 6 hours after treatment)/Initial blood lactate level at presentation] x 100%. The higher positive value means the more relative reduction of blood lactate after treatment from that of initial presentation and indicates a better clinical outcome. (NCT03020407)
Timeframe: 6 hours after treatment
Intervention | percentage change (Median) |
---|
IVC Ultrasound-guided | 39.2 |
Usual Care | 35.9 |
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Time Required to Place the Epidural Catheter
The time required to place the epidural catheter will be recorded (NCT03087604)
Timeframe: From the initiation of procedure to end of procedure
Intervention | minutes (Mean) |
---|
Traditional Technique Group | 33.9 |
Electric Stimulation Group | 24.0 |
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Success Rate of Placement of a Thoracic Epidural
will be determined by the detection of a loss of sensation to cold (ice) in at least two contiguous dermatomal levels, 15 minutes after administration of a test dose of lidocaine through the epidural catheter. If a loss of cold sensation is found, then the epidural placement will be classified as successful. If no loss of cold sensation is found, then the epidural placement will be classified as unsuccessful. (NCT03087604)
Timeframe: 15 minutes after administration of a test dose of lidocaine
Intervention | Participants (Count of Participants) |
---|
Traditional Technique Group | 41 |
Electric Stimulation Group | 45 |
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Subject-reported Visual Analog Scale (VAS) Pain Score Following Tympanic Membrane Tap for Subjects Treated With Active Tymbion Iontophoresis Compared to VAS Score for Subjects Treated With Sham Tymbion Iontophoresis.
"The VAS consists of a 100 millimeter (mm) line with a statement at each end representing the extreme limits of pain intensity (where 0 represents No pain and 100 represents The worst imaginable pain). The subject reports their pain intensity by making a mark along the line and the line is measured to convert the subject response to numeric score (0-100 in millimeters). The data will be summarized as the difference in mean VAS scores between the two treatment groups (active Tymbion iontophoresis compared to sham Tymbion iontophoresis)." (NCT03119181)
Timeframe: Day 0
Intervention | millimeters (Mean) |
---|
Active Tymbion Iontophoresis | 4.2 |
Sham Tymbion Iontophoresis | 18.3 |
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Surgical Field Visualization During Sinus Surgery as Indicated by Score on Boezaart Grading Scale
The minimum Boezaart Grading Scale score of 0 indicates no bleeding (cadaveric conditions), and the maximum score of 5 indicates severe bleeding (constant suctioning required). (NCT03228914)
Timeframe: during surgery approximately 2-3 hours
Intervention | score on a scale (Mean) |
---|
Oxymetazoline | 3 |
Epinephrine | 2.55 |
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Plasma Catecholamine Levels (Maximum Concentration, Area-under-curve (AUC))
"Pharmacokinetics (plasma catecholamine levels: AUC) following intramuscular self-injection of 300mcg and 500mcg adrenaline using an auto-injector device, in food-allergic teenagers over 40kg.~Baseline corrected." (NCT03366298)
Timeframe: At at the following timepoints following injection: 5, 10, 15, 20, 30, 45, 60, 80, 100, 120 and 180 minutes
Intervention | hr*pg/ml (Mean) |
---|
Emerade 300mcg Injection | 174 |
Emerade 500mcg Injection | 387 |
Epipen 0.3mg | 203 |
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Plasma Catecholamine Levels (Maximum Concentration, Cmax)
Pharmacokinetics (plasma catecholamine levels: Cmax) following intramuscular self-injection of 300mcg and 500mcg adrenaline using an auto-injector device, in food-allergic teenagers over 40kg. (NCT03366298)
Timeframe: 3 hours
Intervention | pg/ml (Mean) |
---|
Emerade 300mcg Injection | 218 |
Emerade 500mcg Injection | 394 |
Epipen 0.3mg | 290 |
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Plasma Catecholamine Levels (Time to Maximum Concentration, Tmax)
Pharmacokinetics (plasma catecholamine levels: Tmax) following intramuscular self-injection of 300mcg and 500mcg adrenaline using an auto-injector device, in food-allergic teenagers over 40kg. (NCT03366298)
Timeframe: 3 hours
Intervention | minutes (Mean) |
---|
Emerade 300mcg Injection | 9.6 |
Emerade 500mcg Injection | 8.5 |
Epipen 0.3mg | 5.9 |
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Adverse Events Following Self-administration of Adrenaline Via Autoinjector Device
Adverse events following self-administration of adrenaline via autoinjector device defined as in protocol (NCT03366298)
Timeframe: 1 day
Intervention | Participants (Count of Participants) |
---|
| Pain at injection site | Systemic AE (any) | Palpitations | Tremor |
---|
Emerade 300mcg Injection | 8 | 4 | 3 | 3 |
,Emerade 500mcg Injection | 6 | 9 | 4 | 7 |
,Epipen 0.3mg | 7 | 8 | 3 | 8 |
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Amount of Supplemental Oxycodone Used
Cumulative opioid pain medication used in the first 24 hours postoperatively as recorded in the medical record (NCT03383588)
Timeframe: 4-24 hours post operative
Intervention | mg of supplemental oxycodone (Mean) |
---|
Bupivacaine 0.25% | 19 |
Bupivacaine 0.25% + Epinephrine | 25 |
Saline Solution | 23 |
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Opioid Consumption (Oral Morphine Equivalents)
Total oral morphine equivalent consumption calculated (NCT03408483)
Timeframe: immediately postoperatively to 48 hours postoperatively
Intervention | mg of morphine equivalents (Mean) |
---|
Quadratus Lumborum Block (QLB) | 54.63 |
Standard of Care | 90.76 |
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Pain Scores Using Visual Analog Scale (VAS) Scores
"The Visual Analogue Scale (VAS) is a psychometric response scale which is used in surveys/questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.~The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain. It is for adults and children 10 years old or older:~Rating - Pain Level~0 - No Pain~1-3 - Mild Pain (nagging, annoying, interfering little with *ADLs)~4-6 - Moderate Pain (interferes significantly with ADLs)~7-10 - Severe Pain (disabling; unable to perform ADLs)~*ADL=Activities of Daily Living" (NCT03408483)
Timeframe: Assessed between immediately postoperatively to 12 hours postoperatively
Intervention | units on a scale (Mean) |
---|
Quadratus Lumborum Block (QLB) | 2.34 |
Standard of Care | 3.33 |
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Pain Scores Using Visual Analog Scale (VAS) Scores
"The Visual Analogue Scale (VAS) is a psychometric response scale which is used in surveys/questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.~The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain. It is for adults and children 10 years old or older:~Rating - Pain Level~0 - No Pain~1-3 - Mild Pain (nagging, annoying, interfering little with *ADLs)~4-6 - Moderate Pain (interferes significantly with ADLs)~7-10 - Severe Pain (disabling; unable to perform ADLs)~*ADL=Activities of Daily Living" (NCT03408483)
Timeframe: Assessed between immediately postoperatively to 24 hours postoperatively
Intervention | units on a scale (Mean) |
---|
Quadratus Lumborum Block (QLB) | 2.31 |
Standard of Care | 4.06 |
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Pain Scores Using Visual Analog Scale (VAS) Scores
"The Visual Analogue Scale (VAS) is a psychometric response scale which is used in surveys/questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.~The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain. It is for adults and children 10 years old or older:~Rating - Pain Level~0 - No Pain~1-3 - Mild Pain (nagging, annoying, interfering little with *ADLs)~4-6 - Moderate Pain (interferes significantly with ADLs)~7-10 - Severe Pain (disabling; unable to perform ADLs)~*ADL=Activities of Daily Living" (NCT03408483)
Timeframe: Assessed between immediately postoperatively to 48 hours postoperatively
Intervention | units on a scale (Mean) |
---|
Quadratus Lumborum Block (QLB) | 3.33 |
Standard of Care | 4.11 |
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Pain Scores Using Visual Analog Scale (VAS) Scores
"The Visual Analogue Scale (VAS) is a psychometric response scale which is used in surveys/questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.~The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain. It is for adults and children 10 years old or older:~Rating - Pain Level~0 - No Pain~1-3 - Mild Pain (nagging, annoying, interfering little with *ADLs)~4-6 - Moderate Pain (interferes significantly with ADLs)~7-10 - Severe Pain (disabling; unable to perform ADLs)~*ADL=Activities of Daily Living" (NCT03408483)
Timeframe: Immediately postoperatively to 12 hours postoperatively
Intervention | score on a scale (Mean) |
---|
Quadratus Lumborum Block (QLB) | 2.34 |
Standard of Care | 3.33 |
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Patient Satisfaction
"Patient Satisfaction Score:~Determined by patient interview conducted at the 24 hour Time Frame.~The interview follows a script requesting current pain level based on a scale of 1-10:~1 = very not satisfied 10 = very satisfied~Patient satisfaction is subjective." (NCT03408483)
Timeframe: 24 hours
Intervention | score on a scale (Mean) |
---|
Quadratus Lumborum Block (QLB) | 9.14 |
Standard of Care | 7.46 |
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Distance Ambulated
Physical therapist documentation of ambulation distance measured in feet (NCT03408483)
Timeframe: 24 hours
Intervention | feet (Mean) |
---|
Quadratus Lumborum Block (QLB) | 114.51 |
Standard of Care | 100.85 |
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Distance Ambulated
Physical therapist documentation of ambulation distance measured in feet (NCT03408483)
Timeframe: 48 hours
Intervention | feet (Mean) |
---|
Quadratus Lumborum Block (QLB) | 127.75 |
Standard of Care | 106.69 |
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Hours to Hospital Discharge
From time of the surgical procedure to the time of hospital discharge (measured in hours) up to 3 hours. (NCT03408483)
Timeframe: Maximum 96 Hours
Intervention | hours (Mean) |
---|
Quadratus Lumborum Block (QLB) | 53.17 |
Standard of Care | 55.97 |
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Opioid Consumption (Oral Morphine Equivalents)
Total oral morphine equivalent consumption calculated (NCT03408483)
Timeframe: from 24 hours to 48 hours postoperatively
Intervention | mg of morphine equivalents (Mean) |
---|
Quadratus Lumborum Block (QLB) | 24.26 |
Standard of Care | 40.52 |
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Opioid Consumption (Oral Morphine Equivalents)
Total oral morphine equivalent consumption calculated (NCT03408483)
Timeframe: immediately postoperatively to 24 hours postoperatively
Intervention | mg of morphine equivalents (Mean) |
---|
Quadratus Lumborum Block (QLB) | 30.05 |
Standard of Care | 47.14 |
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Mean Time to Lower Lip Numbness Following Injection
Time in minutes beginning immediately following injection to patient-reported lip numbness (NCT03562481)
Timeframe: Up to 30 minutes following injection
Intervention | minutes (Mean) |
---|
Buffered Anesthetic | 3.4 |
Unbuffered Anesthetic | 4.4 |
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Mean Time to Baseline Lip Sensation
Response in minutes from injection to when lip is no longer numb, as self reported by patient. (NCT03562481)
Timeframe: Within 24 hours following injection
Intervention | minutes (Mean) |
---|
Buffered Anesthetic | 218 |
Unbuffered Anesthetic | 241 |
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Mean Pain Scores Following Injection
"Perceived pain on injection, self-reported verbally using a Likert scale from 1-10, with lower numbers corresponding to less pain (1 = no pain, 10 = worst pain imaginable). Lower scores reflect a lesser degree of pain." (NCT03562481)
Timeframe: Within 10 minutes of injection
Intervention | score on a scale (Mean) |
---|
Buffered Anesthetic | 3.0 |
Unbuffered Anesthetic | 3.3 |
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Average Serum Lidocaine Concentration at 15 Minutes Post Injection
Blood Lidocaine Level (mcg/mL) as measured in 10cc venous blood, taken 15 minutes following injection. Blood assayed for serum lidocaine levels with a Sciex TripleTOF liquid chromatography- mass spectrometry (LC-MS) equipped with a C18 Hypersil (10mm x 2.1mm, 3.0μm). (NCT03562481)
Timeframe: One blood draw taken 15 minutes following injection
Intervention | mcg/ml (Mean) |
---|
Buffered Anesthetic | 243.5 |
Unbuffered Anesthetic | 600.2 |
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Mean Change From Baseline in Average Daily Pain With Walking NPRS (0-10) Score by Subject Type
"The pain with walking Numerical Pain Rating Scale (NPRS) (0-10, 0 being no pain, 10 being greatest pain) collected subjects' average pain with walking over the past 24 hours. Subjects recorded the pain in their target knee, either the index knee or additionally the non-index knee in the case of bilateral subjects. The NPRS was collected at Day 1 (Baseline) and Week 8.~Lower scores (or negative change from baseline) indicate improvement" (NCT03661996)
Timeframe: Baseline, Week 8
Intervention | score on a scale (Least Squares Mean) |
---|
Single Knee Injection (Unilateral Mod-Sev OA Knee Pain) INDEX KNEE | -3.48 |
Single Knee Injection (Non-Index Knee PJR/TJR) INDEX KNEE | -3.52 |
Bilateral Knee Injection (Bilateral Mod-Sev OA Knee Pain) INDEX KNEE | -4.02 |
Bilateral Knee Injection (Bilateral Mod-Sev OA Knee Pain) NON-INDEX KNEE | -3.72 |
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Determination of Optimal Procedure for Administering CNTX-4975-05 With Regards to Pain, Participant Satisfaction, and Investigator's Satisfaction
"A composite score was calculated for each of the 5 treatment regimens by summing the scores of three assessments: (1) procedure pain 30 minutes after injection of CNTX-4975-05 on a 0-4 scale, 0 was best indicating no procedure pain, 4 was worst indicating severe procedure pain; (2) assessment of subjects' satisfaction with the regimen on a scale of 1 (completely dissatisfied) to 7 (completely satisfied), 1 was worst and 7 was best; and (3) assessment of investigators' satisfaction with the regimen on a scale of 1 (completely dissatisfied) to 7 (completely satisfied), 1 was worst and 7 was best.~The procedure pain at 30 minutes was reversed to a 1-7 scale so 7 was best indicating no procedure pain and 1 was worst indicating severe procedure pain. The three assessments were summed for a total score from 3-21, 3 being the worst outcome and 21 being the best outcome. The geometric mean of the scores was derived for each group.~All assessments were administered on Day 1 (Baseline)." (NCT03661996)
Timeframe: Day 1 assessments
Intervention | score on a scale (Geometric Least Squares Mean) |
---|
Group 1. Breg Cooling Control | 17.18 |
Group 2. Gel Pack Cooling | 18.26 |
Group 3. Shortened Gel Pack Cooling | 16.48 |
Group 4. Single Needle Injection Gel Pack Cooling - 2% Lidocaine | 17.40 |
Group 5. Single Needle Injection Gel Pack Cooling - 1% Lidocaine | 16.00 |
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"Mean Change From Baseline in KOOS Symptoms Subscale Score by Subject Type"
"The KOOS (KOOS = Knee Injury and Osteoarthritis Outcome Score) was developed as an extension of the WOMAC (Western Ontario and McMaster Universities Arthritis Index) to evaluate the dimensions of knee osteoarthritis associated pain and injury. It includes 5 separately scored subscales: Pain, Symptoms (including stiffness), Function (Daily Living), Function (Sports and Recreational Activities), and knee-related Quality of Life. Each subscale score is rated on a 5-point scale (i.e., 0 to 4). The previous week is the time period evaluated when answering the questions. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.~The KOOS was administered on Day 1 (Baseline) and Week 8.~Higher scores (or positive change from baseline) indicate improvement." (NCT03661996)
Timeframe: Baseline, Week 8
Intervention | score on a scale (Least Squares Mean) |
---|
Single Knee Injection (Unilateral Mod-Sev OA Knee Pain) INDEX KNEE | 17.15 |
Single Knee Injection (Non-Index Knee PJR/TJR) INDEX KNEE | 20.41 |
Bilateral Knee Injection (Bilateral Mod-Sev OA Knee Pain) INDEX KNEE | 20.05 |
Bilateral Knee Injection (Bilateral Mod-Sev OA Knee Pain) NON-INDEX KNEE | 18.40 |
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"Mean Change From Baseline in KOOS Pain With Walking Single Question Score by Subject Type"
"The KOOS (KOOS = Knee Injury and Osteoarthritis Outcome Score) was developed as an extension of the WOMAC (Western Ontario and McMaster Universities Arthritis Index) to evaluate the dimensions of knee osteoarthritis associated pain and injury. It includes 5 separately scored subscales: Pain, Symptoms (including stiffness), Function (Daily Living), Function (Sports and Recreational Activities), and knee-related Quality of Life. Each subscale score is rated on a 5-point scale (i.e., 0 to 4). The previous week is the time period evaluated when answering the questions. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. The KOOS Pain with Walking is a single question from the KOOS Pain subscale.~The KOOS was administered on Day 1 (Baseline) and Week 8.~Higher scores (or positive change from baseline) indicate improvement." (NCT03661996)
Timeframe: Baseline, Week 8
Intervention | score on a scale (Least Squares Mean) |
---|
Single Knee Injection (Unilateral Mod-Sev OA Knee Pain) INDEX KNEE | 21.08 |
Single Knee Injection (Non-Index Knee PJR/TJR) INDEX KNEE | 25.26 |
Bilateral Knee Injection (Bilateral Mod-Sev OA Knee Pain) INDEX KNEE | 25.85 |
Bilateral Knee Injection (Bilateral Mod-Sev OA Knee Pain) NON-INDEX KNEE | 23.34 |
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"Mean Change From Baseline in KOOS Pain Subscale Score by Subject Type"
"The KOOS (KOOS = Knee Injury and Osteoarthritis Outcome Score) was developed as an extension of the WOMAC (Western Ontario and McMaster Universities Arthritis Index) to evaluate the dimensions of knee osteoarthritis associated pain and injury. It includes 5 separately scored subscales: Pain, Symptoms (including stiffness), Function (Daily Living), Function (Sports and Recreational Activities), and knee-related Quality of Life. Each subscale score is rated on a 5-point scale (i.e., 0 to 4). The previous week is the time period evaluated when answering the questions. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.~The KOOS was administered on Day 1 (Baseline) and Week 8.~Higher scores (or positive change from baseline) indicate improvement." (NCT03661996)
Timeframe: Baseline, Week 8
Intervention | score on a scale (Least Squares Mean) |
---|
Single Knee Injection (Unilateral Mod-Sev OA Knee Pain) INDEX KNEE | 22.45 |
Single Knee Injection (Non-Index Knee PJR/TJR) INDEX KNEE | 23.90 |
Bilateral Knee Injection (Bilateral Mod-Sev OA Knee Pain) INDEX KNEE | 25.62 |
Bilateral Knee Injection (Bilateral Mod-Sev OA Knee Pain) NON-INDEX KNEE | 22.10 |
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"Mean Change From Baseline in KOOS Knee-Related Quality of Life Subscale Score by Subject Type"
"The KOOS (KOOS = Knee Injury and Osteoarthritis Outcome Score) was developed as an extension of the WOMAC (Western Ontario and McMaster Universities Arthritis Index) to evaluate the dimensions of knee osteoarthritis associated pain and injury. It includes 5 separately scored subscales: Pain, Symptoms (including stiffness), Function (Daily Living), Function (Sports and Recreational Activities), and knee-related QOL. Each subscale score is rated on a 5-point scale (i.e., 0 to 4). The previous week is the time period evaluated when answering the questions. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.~The KOOS was administered on Day 1 (Baseline) and Week 8.~Higher scores (or positive change from baseline) indicate improvement." (NCT03661996)
Timeframe: Baseline, Week 8
Intervention | score on a scale (Least Squares Mean) |
---|
Single Knee Injection (Unilateral Mod-Sev OA Knee Pain) INDEX KNEE | 22.10 |
Single Knee Injection (Non-Index Knee PJR/TJR) INDEX KNEE | 16.75 |
Bilateral Knee Injection (Bilateral Mod-Sev OA Knee Pain) INDEX KNEE | 21.52 |
Bilateral Knee Injection (Bilateral Mod-Sev OA Knee Pain) NON-INDEX KNEE | 19.40 |
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"Mean Change From Baseline in KOOS Function (Sport and Recreational Activities) Subscale Score by Subject Type"
"The KOOS (KOOS = Knee Injury and Osteoarthritis Outcome Score) was developed as an extension of the WOMAC (Western Ontario and McMaster Universities Arthritis Index) to evaluate the dimensions of knee osteoarthritis associated pain and injury. It includes 5 separately scored subscales: Pain, Symptoms (including stiffness), Function (Daily Living), Function (Sports and Recreational Activities), and knee-related QOL. Each subscale score is rated on a 5-point scale (i.e., 0 to 4). The previous week is the time period evaluated when answering the questions. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.~The KOOS was administered on Day 1 (Baseline) and Week 8.~Higher scores (or positive change from baseline) indicate improvement." (NCT03661996)
Timeframe: Baseline, Week 8
Intervention | score on a scale (Least Squares Mean) |
---|
Single Knee Injection (Unilateral Mod-Sev OA Knee Pain) INDEX KNEE | 25.17 |
Single Knee Injection (Non-Index Knee PJR/TJR) INDEX KNEE | 33.11 |
Bilateral Knee Injection (Bilateral Mod-Sev OA Knee Pain) INDEX KNEE | 27.80 |
Bilateral Knee Injection (Bilateral Mod-Sev OA Knee Pain) NON-INDEX KNEE | 24.80 |
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"Mean Change From Baseline in KOOS Function (Daily Living) Subscale Score by Subject Type"
"The KOOS (KOOS = Knee Injury and Osteoarthritis Outcome Score) was developed as an extension of the WOMAC (Western Ontario and McMaster Universities Arthritis Index) to evaluate the dimensions of knee osteoarthritis associated pain and injury. It includes 5 separately scored subscales: Pain, Symptoms (including stiffness), Function (Daily Living), Function (Sports and Recreational Activities), and knee-related QOL. Each subscale score is rated on a 5-point scale (i.e., 0 to 4). The previous week is the time period evaluated when answering the questions. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.~The KOOS was administered on Day 1 (Baseline) and Week 8.~Higher scores (or positive change from baseline) indicate improvement." (NCT03661996)
Timeframe: Baseline, Week 8
Intervention | score on a scale (Least Squares Mean) |
---|
Single Knee Injection (Unilateral Mod-Sev OA Knee Pain) INDEX KNEE | 20.86 |
Single Knee Injection (Non-Index Knee PJR/TJR) INDEX KNEE | 25.66 |
Bilateral Knee Injection (Bilateral Mod-Sev OA Knee Pain) INDEX KNEE | 25.57 |
Bilateral Knee Injection (Bilateral Mod-Sev OA Knee Pain) NON-INDEX KNEE | 22.26 |
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VAS Pain Score
Using a 10 point visual analog scale (VAS) score. The score ranges from 0 to 10. '0' represents no pain and '10' represents worst pain. (NCT03682224)
Timeframe: In-hospital until discharge, approximately 3 days, will be collected each time before dispensing pain medications
Intervention | score on a scale (Median) |
---|
Exparel | 4.8 |
Marcaine | 5.2 |
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Mortality
Any death occurring during primary hospital stay or prior to 30 days post surgery (NCT03682224)
Timeframe: Up to 30 days post surgery
Intervention | Participants (Count of Participants) |
---|
Exparel | 0 |
Marcaine | 0 |
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Treatment Cost
All direct cost from the date of surgery until discharge (NCT03682224)
Timeframe: In-hospital Costs until discharge, approximately 3 days
Intervention | United States Dollars (Median) |
---|
Exparel | 22,775 |
Marcaine | 20,252 |
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Total Morphine Equivalents Consumed
Measured as overall intake of any drugs in the opioid class (Morphine Equivalent Dosing) (NCT03682224)
Timeframe: up to 72 hours post surgery
Intervention | MEq (Median) |
---|
Exparel | 48 |
Marcaine | 42.7 |
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Prolonged Air Leak
Number of patients who had air leak more than 5 days post-surgery (NCT03682224)
Timeframe: > 5 days to 7 days
Intervention | Participants (Count of Participants) |
---|
Exparel | 8 |
Marcaine | 5 |
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Pharmacy Cost
Median In-hospital pharmacy cost (NCT03682224)
Timeframe: In-hospital until discharge, approximately 3 days
Intervention | United States Dollars (Median) |
---|
Exparel | 1052 |
Marcaine | 596 |
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Hospital Stay
(NCT03682224)
Timeframe: Length of hospital stay - from admission to discharge, approximately 3 days
Intervention | Days (Median) |
---|
Exparel | 3.28 |
Marcaine | 2.45 |
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Atrial Fibrillation/Other Arrhythmia
Post-op arrhythmia (NCT03682224)
Timeframe: In-hospital until discharge, approximately 3 days
Intervention | Participants (Count of Participants) |
---|
Exparel | 2 |
Marcaine | 3 |
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Pneumothorax
Documented pnuemothorax (NCT03682224)
Timeframe: In-hospital until discharge, approximately 3 days
Intervention | Participants (Count of Participants) |
---|
Exparel | 5 |
Marcaine | 6 |
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Cumulative 48-hour Post Surgical Opiate Use (Oral Morphine Equivalent)
(NCT03723447)
Timeframe: 48-hours
Intervention | Oral morphine equivalents (Median) |
---|
Bupivacaine/Epinephrine/Dexamethasone TAP Block | 47 |
Liposomal Bupivacaine TAP Block | 69 |
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Post-op Pain Score (Visual Analog Scale)
Visual pain scale recordings will be totaled and averaged during the first 72-hours post-surgery. Visual analog scale is determined by nursing staff when assessing pain scores. Scores range from 0-10 with 10 being the most pain. These values are typically interpreted by nursing staff as mild, moderate, or severe pain and pain medication is given accordingly. (NCT03723447)
Timeframe: 72-hours post-surgery
Intervention | score on a scale (Median) |
---|
Bupivacaine/Epinephrine/Dexamethasone TAP Block | 4 |
Liposomal Bupivacaine TAP Block | 4 |
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Postoperative Length of Stay
Time from operation until hospital discharge (NCT03723447)
Timeframe: 30 days post-surgery
Intervention | days (Median) |
---|
Bupivacaine/Epinephrine/Dexamethasone TAP Block | 3 |
Liposomal Bupivacaine TAP Block | 3 |
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Bowel Motility
Time till first bowel movement (NCT03723447)
Timeframe: 72 hours post-surgery
Intervention | days (Median) |
---|
Bupivacaine/Epinephrine/Dexamethasone TAP Block | 1 |
Liposomal Bupivacaine TAP Block | 1 |
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Assessment of Patient Overall Satisfaction With Pain Control
Patient overall satisfaction with pain control was assessed two times; on the fourth and the 60th postoperative days. It was assessed using a numeric scale (0-10) where 0 is very dissatisfied while 10 is extremely satisfied. The results indicated only the percentage of participants who reported a 10/10 satisfaction rate. (NCT03887650)
Timeframe: POD4 - 60 days
Intervention | Participants (Count of Participants) |
---|
| POD472268834 | POD472268835 | POD6072268834 | POD6072268835 |
---|
| 10/10 | below 10 | Missing data |
---|
Liposomal Bupivacaine 1.3% | 32 |
Bupivacaine 0.5% With Adjuncts | 24 |
Liposomal Bupivacaine 1.3% | 9 |
Bupivacaine 0.5% With Adjuncts | 17 |
Liposomal Bupivacaine 1.3% | 4 |
Bupivacaine 0.5% With Adjuncts | 1 |
Liposomal Bupivacaine 1.3% | 27 |
Bupivacaine 0.5% With Adjuncts | 28 |
Liposomal Bupivacaine 1.3% | 12 |
Bupivacaine 0.5% With Adjuncts | 13 |
Liposomal Bupivacaine 1.3% | 5 |
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Pain Assessment at Post Anesthesia Care Unit (PACU)-96 Postoperative Hours
Pain assessment is categorized as minimum, maximum, and average pain scores reported by patients using questions from the Modified Brief Pain Inventory-short form (MBPI-SF) during the following intervals; PACU-24, 24-48, 48-72, and 72-96 postoperative hours, and at day 60. This form collected minimum, maximum, and average on a numeric pain scale (0-10) where 0 is no pain and 10 is the worst pain. (NCT03887650)
Timeframe: 24, 24-48, 48-72, and 72-96 hours postoperation, and at day 60
Intervention | units on a scale 0-10 (Median) |
---|
| PACU | PACU-24 hours Minimum | PACU-24 hours Maximum | PACU-24 hours Average | 24-48 hours Minimum | 24-48 hours Maximum | 24-48 hours Average | 48-72 hours Minimum | 48-72 hours Maximum | 48-72 hours Average | 72-96 hours Minimum | 72-96 hours Maximum | 72-96 hours Average | 60 days postoperative Maximum | 60 days postoperative Average | 60 days postoperative Minimum |
---|
Bupivacaine 0.5% With Adjuncts | 0.00 | 0.00 | 1.00 | 0.00 | 2.00 | 7.00 | 4.00 | 2.00 | 6.00 | 3.00 | 2.00 | 5.00 | 3.00 | 6.00 | 2.00 | 0.00 |
,Liposomal Bupivacaine 1.3% | 0.00 | 0.00 | 2.00 | 1.00 | 0.00 | 4.50 | 2.00 | 1.00 | 4.00 | 2.00 | 0.50 | 4.00 | 2.00 | 5.00 | 1.00 | 0.00 |
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Day of the Final Opioids Used
The postoperative day that patients in each group took their last opioid, from the end of surgery up to 96 postoperative hours. (NCT03887650)
Timeframe: 0-96 postoperative hours
Intervention | day (Median) |
---|
Liposomal Bupivacaine 1.3% | 4 |
Bupivacaine 0.5% With Adjuncts | 4 |
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Hospital Length-of-stay
From the date and time of admission to the date and time of discharge, Measured in hours. (NCT03887650)
Timeframe: From the date of admission until discharge, assessed up to 72 hours.
Intervention | hour (Median) |
---|
Liposomal Bupivacaine 1.3% | 31.05 |
Bupivacaine 0.5% With Adjuncts | 31.63 |
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Time to First Opioid Medication
From block time to the first dose of opioids given, measured in hours. (NCT03887650)
Timeframe: from the time of the block injection until discharge, assessed up to 72 postoperative hours.
Intervention | hours (Median) |
---|
Liposomal Bupivacaine 1.3% | 10.5667 |
Bupivacaine 0.5% With Adjuncts | 12.025 |
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Total Opioid Consumption
Total opioids used for the first 120 postoperative hours after TSA, standardized to morphine milligram equivalents (MMEs) (NCT03887650)
Timeframe: Up to 120 postoperative hours
Intervention | MME (Median) |
---|
Liposomal Bupivacaine 1.3% | 71.25 |
Bupivacaine 0.5% With Adjuncts | 90.30 |
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Motor Recovery
"The Motor function was assessed by shoulder abduction and elbow flexion using the Oxford scale of muscle strength grading (Muscle Grading Scores 0-5):~0= No detectable muscle contraction (visible or palpation)~Detectable contraction (visible or palpation), but no movement achieved~Limb movement achieved, but unable to move against gravity~Limb movement against the resistance of gravity~Limb movement against gravity and external resistance~Normal strength~The results were grouped to show the return of any movement at the PACU, Day 1, after Day 1 (day2-60), and on day 60. And the return of full movement between day 2 and 60 and at day 60, in addition to the missing data." (NCT03887650)
Timeframe: PACU, Day 1, after Day 1 (day 2 and 60), and at postoperative day 60.
Intervention | Participants (Count of Participants) |
---|
| Any movement in PACU | Any movement in day1 | Any movement after day1 | Any movement missing data | Return of full movement day 2-60 | Not yet by day 60 | Return of full movement missing data |
---|
Bupivacaine 0.5% With Adjuncts | 11 | 3 | 29 | 2 | 31 | 6 | 8 |
,Liposomal Bupivacaine 1.3% | 1 | 4 | 38 | 2 | 32 | 3 | 10 |
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Incidence of Distress From Block Numbness
On a distress scale of (0 -10) with 0 = not at all and 10 = very much distressed, the scores were gathered and the results are grouped to show the percentage of either the presence of distress (any positive score) or no distress, assessed at two times; at the PACU and the second postoperative day. (NCT03887650)
Timeframe: At PACU and Postoperative day 2
Intervention | Participants (Count of Participants) |
---|
| PACU distress72268834 | PACU distress72268835 | POD2 Distress72268834 | POD2 Distress72268835 |
---|
| No distress | any distress | Missing data |
---|
Liposomal Bupivacaine 1.3% | 31 |
Bupivacaine 0.5% With Adjuncts | 31 |
Liposomal Bupivacaine 1.3% | 14 |
Bupivacaine 0.5% With Adjuncts | 14 |
Liposomal Bupivacaine 1.3% | 0 |
Bupivacaine 0.5% With Adjuncts | 0 |
Liposomal Bupivacaine 1.3% | 32 |
Liposomal Bupivacaine 1.3% | 12 |
Bupivacaine 0.5% With Adjuncts | 12 |
Liposomal Bupivacaine 1.3% | 1 |
Bupivacaine 0.5% With Adjuncts | 2 |
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Duration of Sensory Nerve Block
Using the sensory assessment test, the results show the percentage of participants who had the return of first sensation and full sensation either on Day 1, after Day 1 (day 2 to 60), and at postoperative day 60. (NCT03887650)
Timeframe: Day 1, after Day 1 (day 2 to 60), and at postoperative day 60
Intervention | Participants (Count of Participants) |
---|
| Full sensation72268834 | Full sensation72268835 | First sensation72268834 | First sensation72268835 |
---|
| Returned on day 1 after the block | Returned on day 2-60 | Not by day 60 | Missing data |
---|
Liposomal Bupivacaine 1.3% | 11 |
Bupivacaine 0.5% With Adjuncts | 11 |
Liposomal Bupivacaine 1.3% | 27 |
Bupivacaine 0.5% With Adjuncts | 27 |
Liposomal Bupivacaine 1.3% | 0 |
Bupivacaine 0.5% With Adjuncts | 2 |
Liposomal Bupivacaine 1.3% | 7 |
Bupivacaine 0.5% With Adjuncts | 5 |
Liposomal Bupivacaine 1.3% | 35 |
Bupivacaine 0.5% With Adjuncts | 33 |
Liposomal Bupivacaine 1.3% | 9 |
Bupivacaine 0.5% With Adjuncts | 10 |
Bupivacaine 0.5% With Adjuncts | 0 |
Liposomal Bupivacaine 1.3% | 1 |
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Total Amount of Opioid Consumed During the Indicated Time Periods
Opioid use was calculated using the Morphine MilliEquevalent per day, this was assessed daily during the postoperative period, 0-24, 24-48, 48-72, and 72-120 postoperative hours. (NCT03887650)
Timeframe: 0-24, 24-48, 48-72, and 72-120 postoperative hours.
Intervention | MME/day (Median) |
---|
| 0-24 hours | 24-48 hours | 48-72 hours | 72-120 hours |
---|
Bupivacaine 0.5% With Adjuncts | 25.00 | 23.25 | 5.00 | 15.00 |
,Liposomal Bupivacaine 1.3% | 25.00 | 16.00 | 2.00 | 10.00 |
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Pain Outcome: Visual Analog Scale
Assessed using the visual analog scale (0-10 scale). Zero indicates no pain, 10 indicates worst pain ever (NCT04023695)
Timeframe: Assessed after 24 hours after injection (by phone)
Intervention | units on a scale (Mean) |
---|
Corticosteroid With Lidocaine With Epinephrine | 1.2 |
Corticosteroid With Normal Saline | 1 |
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Pain Outcome: Visual Analog Scale
Assessed using the visual analog scale (0-10 scale). Zero indicates no pain, 10 indicates worst pain ever (NCT04023695)
Timeframe: Assessed 1 minute after injection (in clinic)
Intervention | score on a scale (Mean) |
---|
Corticosteroid With Lidocaine With Epinephrine | 3.5 |
Corticosteroid With Normal Saline | 2 |
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en Bloc Resection
Number of polyps removed en bloc (in 1 piece) vs number of polyps removed piecemeal (in more than 1 piece) (NCT04065451)
Timeframe: During the colonoscopy procedure, an average of 47.3 minutes
Intervention | Polyps (Number) |
---|
| En bloc removal | Piecemeal removal |
---|
Epinephrine | 0 | 11 |
,No Epinephrine | 0 | 10 |
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Quality of the Mound
Endoscopist impression of lift provided by the submucosal injection: excellent/adequate or insufficient. Excellent is the best rating and insufficient is the worst rating on this scale. (NCT04065451)
Timeframe: During the colonoscopy procedure, an average of 47.3 minutes
Intervention | Polyps (Count of Units) |
---|
| Excellent/adequate | insufficient | Unknown |
---|
Epinephrine | 9 | 0 | 2 |
,No Epinephrine | 8 | 2 | 0 |
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Immediate Post-polypectomy Pain
Pain related by the participant on a 0-100 visual analog scale; patients will be asked to mark their pain level on a straight vertical line 100 mm long and this point will be measured with a ruler for pain score. Possible values are zero- indicating no pain at all to 100-indicating worst imaginable pain (NCT04065451)
Timeframe: 30 minutes after the procedure
Intervention | units on a scale (Mean) |
---|
Epinephrine | 46.5 |
No Epinephrine | 13.6 |
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Immediate Post Polypectomy Pain (1hour)
Pain related by the participant on a 0-100 visual analog scale; patients will be asked to mark their pain level on a straight vertical line 100 mm long and this point will be measured with a ruler for pain score. Possible values are zero- indicating no pain at all to 100-indicating worst imaginable pain (NCT04065451)
Timeframe: 1 hour after procedure
Intervention | Units on a Scale (Mean) |
---|
Epinephrine | 44 |
No Epinephrine | 12.9 |
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Sydney Resection Quotient
size of the polyp in mm divided by the number of pieces the polyps is removed in (NCT04065451)
Timeframe: During the colonoscopy procedure, an average of 47.3 minutes
Intervention | Ratio (Median) |
---|
Epinephrine | 5 |
No Epinephrine | 4.2 |
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Need for Additional Local Anesthetic
Need for additional infiltrated local anesthetic (lidocaine) (NCT04203225)
Timeframe: At any time during suturing procedure, time frame is duration of procedure, generally 10-20 minutes, less than one hour. Determined by chart review immediately after procedure completion.
Intervention | Participants (Count of Participants) |
---|
Single LET | 4 |
Triple LET | 5 |
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Visual Analog Scale Pain Score
Pain score self-rated by patient on 100m Visual Analog Pain scale, minimum value 0, maximum value 100, higher scores equal more pain (worse outcome) (NCT04203225)
Timeframe: Immediately on placement or attempt at placement of first suture
Intervention | mm (Mean) |
---|
Single LET | 16 |
Triple LET | 16 |
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C[Max], Maximum Plasma Concentration of Albuterol or Epinephrine
Pharmacokinetic (PK) blood samples will be collected starting 30 minutes before dose and until 24 hours after dose. Plasma will be isolated for analyzing the concentrations of Albuterol and Epinephrine. C[max] will be obtained directly from the plot of PK curve. (NCT04207840)
Timeframe: Samples were drawn at 30 minutes pre-dose and at 1, 2, 3, 5, 7, 9, 12, 15, 18, 21, 25, 30, 40, 50, 60, 70, 80, 90, 120 minutes, 4, 6, 8, 12, 18, and 24 hours post-dose.
Intervention | pg/mL (Geometric Mean) |
---|
Primatene Mist, E004 | 240.8 |
Epinephrine Injection Auto-Injector (Generic of EpiPen) | 704.8 |
Albuterol HFA | 599.8 |
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AUC(0-tm)_TOT, Area Under the Curve (AUC) of Total (Exogenous and Endogenous, if Available) Active Product Ingredient (API) From Time 0 to Time (tm)
Pharmacokinetic (PK) blood samples will be collected starting 30 minutes before dose and until 24 hours after dose. Plasma will be isolated for analyzing the concentrations of Albuterol and Epinephrine. AUC(0-tm)_TOT will be calculated with the trapezoid method. Time tm is defined as the time after C[max] is reached where API concentration is reduced to the levels of the same day baseline. (NCT04207840)
Timeframe: Samples were drawn at 30 minutes pre-dose and at 1, 2, 3, 5, 7, 9, 12, 15, 18, 21, 25, 30, 40, 50, 60, 70, 80, 90, 120 minutes, 4, 6, 8, 12, 18, and 24 hours post-dose.
Intervention | pg/mL x hr (Geometric Mean) |
---|
Primatene Mist, E004 | 26.8 |
Epinephrine Injection Auto-Injector (Generic of EpiPen) | 509.9 |
Albuterol HFA | 3332.3 |
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AUC(0-tm)_DE, Area Under the Curve (AUC) of Exogenous Active Product Ingredient (API) From Time 0 to Time (tm)
Pharmacokinetic (PK) blood samples will be collected starting 30 minutes before dose and until 24 hours after dose. Plasma will be isolated for analyzing the concentrations of Albuterol and Epinephrine. AUC(0-tm)_DE will be calculated with the trapezoid method. Time tm is defined as the time after C[max] is reached where API concentration is reduced to the levels of the same day baseline. (NCT04207840)
Timeframe: Samples were drawn at 30 minutes pre-dose and at 1, 2, 3, 5, 7, 9, 12, 15, 18, 21, 25, 30, 40, 50, 60, 70, 80, 90, 120 minutes, 4, 6, 8, 12, 18, and 24 hours post-dose.
Intervention | pg/mL x hr (Geometric Mean) |
---|
Primatene Mist, E004 | 18.4 |
Epinephrine Injection Auto-Injector (Generic of EpiPen) | 396.3 |
Albuterol HFA | 3332.3 |
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AUC(0-inf), Area Under the Curve (AUC) of Albuterol or Epinephrine From Time 0 to Infinity
Pharmacokinetic (PK) blood samples will be collected starting 30 minutes before dose and until 24 hours after dose. Plasma will be isolated for analyzing the concentrations of Albuterol and Epinephrine. AUC(0-inf) will be calculated with the extrapolation method. (NCT04207840)
Timeframe: Samples were drawn at 30 minutes pre-dose and at 1, 2, 3, 5, 7, 9, 12, 15, 18, 21, 25, 30, 40, 50, 60, 70, 80, 90, 120 minutes, 4, 6, 8, 12, 18, and 24 hours post-dose.
Intervention | pg/mL x hr (Geometric Mean) |
---|
Primatene Mist, E004 | 18.4 |
Epinephrine Injection Auto-Injector (Generic of EpiPen) | 411.4 |
Albuterol HFA | 3650.4 |
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t[Max], Time at Which Maximum Plasma Concentration of Albuterol or Epinephrine is Observed
Pharmacokinetic (PK) blood samples will be collected starting 30 minutes before dose and until 24 hours after dose. Plasma will be isolated for analyzing the concentrations of Albuterol and Epinephrine. t[max] will be obtained directly from the plot of PK curve when the maximum concentration is observed. (NCT04207840)
Timeframe: Samples were drawn at 30 minutes pre-dose and at 1, 2, 3, 5, 7, 9, 12, 15, 18, 21, 25, 30, 40, 50, 60, 70, 80, 90, 120 minutes, 4, 6, 8, 12, 18, and 24 hours post-dose.
Intervention | min (Geometric Mean) |
---|
Primatene Mist, E004 | 2.6 |
Epinephrine Injection Auto-Injector (Generic of EpiPen) | 8.3 |
Albuterol HFA | 21.8 |
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t[1/2], Terminal Elimination Half-life of Albuterol or Epinephrine
Pharmacokinetic (PK) blood samples will be collected starting 30 minutes before dose and until 24 hours after dose. Plasma will be isolated for analyzing the concentrations of Albuterol and Epinephrine. (NCT04207840)
Timeframe: Samples were drawn at 30 minutes pre-dose and at 1, 2, 3, 5, 7, 9, 12, 15, 18, 21, 25, 30, 40, 50, 60, 70, 80, 90, 120 minutes, 4, 6, 8, 12, 18, and 24 hours post-dose.
Intervention | min (Geometric Mean) |
---|
Primatene Mist, E004 | 7.1 |
Epinephrine Injection Auto-Injector (Generic of EpiPen) | 138.8 |
Albuterol HFA | 420.7 |
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Time Until First Opioid Request
(NCT04369950)
Timeframe: Up to 48 hours after epidural morphine administration
Intervention | hours (Median) |
---|
2 Percent Lidocaine With Epinephrine and Epidural Morphine | 14.8 |
3 Percent 2-Chloroprocaine and Epidural Morphine | 24.7 |
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Total Amount of Opioid Used
(NCT04369950)
Timeframe: 12 hours after epidural morphine administration
Intervention | hours (Median) |
---|
2 Percent Lidocaine With Epinephrine and Epidural Morphine | 0 |
3 Percent 2-Chloroprocaine and Epidural Morphine | 0 |
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Total Amount of Opioid Used
(NCT04369950)
Timeframe: 24 hours after epidural morphine administration
Intervention | milligrams (Median) |
---|
2 Percent Lidocaine With Epinephrine and Epidural Morphine | 15 |
3 Percent 2-Chloroprocaine and Epidural Morphine | 0 |
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Total Amount of Opioid Used
(NCT04369950)
Timeframe: 4 hours after epidural morphine administration
Intervention | hours (Median) |
---|
2 Percent Lidocaine With Epinephrine and Epidural Morphine | 0 |
3 Percent 2-Chloroprocaine and Epidural Morphine | 0 |
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Total Amount of Opioid Used
(NCT04369950)
Timeframe: 8 hours after epidural morphine administration
Intervention | hours (Median) |
---|
2 Percent Lidocaine With Epinephrine and Epidural Morphine | 0 |
3 Percent 2-Chloroprocaine and Epidural Morphine | 0 |
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Number of Participants Who Had Mild, Moderate or Severe Nausea as Measured by a 3 Point Scale
scale ranges from non,mild and moderate-severe (NCT04369950)
Timeframe: 4,8, 12 and 24 hours after epidural morphine administration
Intervention | Participants (Count of Participants) |
---|
| 4 hours | 8 hours | 12 hours | 24 hours |
---|
2 Percent Lidocaine With Epinephrine and Epidural Morphine | 3 | 1 | 0 | 0 |
,3 Percent 2-Chloroprocaine and Epidural Morphine | 1 | 2 | 0 | 0 |
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Number of Participants Who Had Mild, Moderate or Severe Pruritis as Measured by a 3 Point Scale
scale ranges from non,mild and moderate-severe (NCT04369950)
Timeframe: 4,8, 12 and 24 hours after epidural morphine administration
Intervention | Participants (Count of Participants) |
---|
| 4 hours | 8 hours | 12 hours | 24 hours |
---|
2 Percent Lidocaine With Epinephrine and Epidural Morphine | 7 | 6 | 4 | 2 |
,3 Percent 2-Chloroprocaine and Epidural Morphine | 3 | 4 | 3 | 0 |
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Pain as Measured by a 11 Point Verbal Scale
scale ranges form 0-10, higher number indicating more pain (NCT04369950)
Timeframe: 4,8, 12 and 24 hours after epidural morphine administration
Intervention | score on a scale (Median) |
---|
| 4 hours | 8 hours | 12 hours | 24 hours |
---|
2 Percent Lidocaine With Epinephrine and Epidural Morphine | 0 | 0 | 3 | 7 |
,3 Percent 2-Chloroprocaine and Epidural Morphine | 2.5 | 1 | 2 | 3.5 |
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Hemostasis Efficacy
To determine time to achieving hemostasis (based upon subjective assessment of surgeon) on patients receiving treatment with topical racemic epinephrine compared to those receiving a placebo. (NCT04688346)
Timeframe: 5 minutes
Intervention | Minutes (Mean) |
---|
Control | 4.2 |
Intervention | 2.2 |
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Cardiovascular Outcomes
To determine heart rate change of patients receiving treatment with topical racemic epinephrine compared to those receiving a placebo. (NCT04688346)
Timeframe: 5 minutes
Intervention | Beats Per Minute (Mean) |
---|
Control | 91.5 |
Intervention | 93.4 |
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Cardiovascular Outcomes
To determine blood pressure change of patients receiving treatment with topical racemic epinephrine compared to those receiving a placebo. (NCT04688346)
Timeframe: 5 minutes
Intervention | mmhg (Mean) |
---|
Control | -3.1 |
Intervention | -2.7 |
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Total Operative Time
(NCT05244525)
Timeframe: end of surgery(about 30-120 minutes from start of surgery)
Intervention | minutes (Mean) |
---|
Treatment | 62 |
Control Group | 64 |
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Surgeon-rated Visual Clarity as Assessed by the Visual Analog Scale
This scale is scored from 1-10, a higher number indicating better clarity (NCT05244525)
Timeframe: end of surgery(about 30-120 minutes from start of surgery)
Intervention | score on a scale (Mean) |
---|
Treatment | 8.3 |
Control Group | 7.5 |
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Percentage of Participants for Whom Intra-operative Arthroscopic Pump Pressure Was Increased to 45mmHg or Higher During the Surgical Procedure
The pump pressure is initially set at 35mmHg during the arthroscopic surgical procedure. If visualization is limited during the procedure, surgeons may increase the pump pressure of arthroscopic fluid within the shoulder during the procedure. This outcome measure reports the percentage of participants for whom intra-operative arthroscopic pump pressure was increased to 45mmHg or higher during the surgical procedure. (NCT05244525)
Timeframe: From start of surgery to end of surgery(about 30-120 minutes)
Intervention | percent (Number) |
---|
Treatment | 22 |
Control Group | 23 |
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Number of Subjects Who Experience Intraoperative Adverse Events
(NCT05244525)
Timeframe: end of surgery(about 30-120 minutes from start of surgery)
Intervention | Participants (Count of Participants) |
---|
Treatment | 0 |
Control Group | 0 |
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Intraoperative Mean Arterial Pressure
(NCT05244525)
Timeframe: end of surgery(about 30-120 minutes from start of surgery)
Intervention | mmHg (Mean) |
---|
Treatment | 70.5 |
Control Group | 71.3 |
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Number of Subjects Who Experience Post Operative Adverse Events
(NCT05244525)
Timeframe: from the end of surgery up to 2 weeks post surgery
Intervention | Participants (Count of Participants) |
---|
Treatment | 0 |
Control Group | 0 |
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Change in Systemic Vascular Resistance Index (SVRI) to Pulmonary Vascular Resistance Index (PVRI) Ratio (Rp:Rs Ratio)
In patients with pulmonary hypertension (PH) one anticipates a greater increase in pulmonary vascular resistance as opposed to systemic vascular resistance when vasopressors are administered. (NCT05439460)
Timeframe: Day 1 (at baseline and up to 5 minutes following study drug administration) (Q: 2 minutes - 2 to 5 minutes?)
Intervention | Rp:Rs ratio (Mean) |
---|
| Baseline | Approx. 2 minutes following drug administration |
---|
Arginine Vasopressin | 0.75 | 0.49 |
,Epinephrine | 0.61 | 0.6 |
,Phenylephrine | 0.8 | 0.73 |
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Number of Nostrils With Continuous Fresh Bleeding
Number of nostrils with excessive fresh bleeding postoperatively using the 1-week postoperative bleeding questionnaire. Continuous fresh bleeding was defined as bleeding for over 15 minutes. (NCT05867342)
Timeframe: 1 week after the surgery (up to 2 minutes to complete assessment)
Intervention | nostrils (Count of Units) |
---|
1:1000 Epinephrine Plus Saline | 7 |
1:1000 Epinephrine Plus Infiltration of 1% Lidocaine With 1:100,000 Epinephrine | 5 |
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Postoperative Bloody Discharge Grading Score
Grading of postoperative bloody discharge postoperatively assessed by patient using the 1-week postoperative bleeding questionnaire. Scores range from 0 (no bleeding) to 5 (continuous heavy bleeding necessitating medical care). (NCT05867342)
Timeframe: 1 week after the surgery (up to 2 minutes to complete assessment)
Intervention | score on a scale (Mean) |
---|
1:1000 Epinephrine Plus Saline | 2.38 |
1:1000 Epinephrine Plus Infiltration of 1% Lidocaine With 1:100,000 Epinephrine | 2.2 |
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Surgical Field Grading Score
The video recording of the endoscopic sinus surgery of the participant was graded by another otolaryngology specialist postoperatively and graded according to Wormald Surgical Field Grading Scale. Scores range from 0 (no bleeding) to 10 (severe bleeding with nasal cavity filling rapidly). (NCT05867342)
Timeframe: postoperatively (approximately 20 minutes to assess)
Intervention | score on a scale (Mean) |
---|
1:1000 Epinephrine Plus Saline | 3.54 |
1:1000 Epinephrine Plus Infiltration of 1% Lidocaine With 1:100,000 Epinephrine | 3.23 |
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Estimated Blood Loss During Surgery
(NCT05867342)
Timeframe: intraoperatively (up to 3 hours)
Intervention | mL (Mean) |
---|
1:1000 Epinephrine Plus Saline | 95.25 |
1:1000 Epinephrine Plus Infiltration of 1% Lidocaine With 1:100,000 Epinephrine | 91.63 |
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Number of Days With Postoperative Bloody Nasal Discharge
Participants indicated number of days with bloody nasal discharge postoperatively using the 1-week postoperative bleeding questionnaire. (NCT05867342)
Timeframe: 1 week after the surgery (up to 2 minutes to complete assessment)
Intervention | days (Mean) |
---|
1:1000 Epinephrine Plus Saline | 2.85 |
1:1000 Epinephrine Plus Infiltration of 1% Lidocaine With 1:100,000 Epinephrine | 2.73 |
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Duration of Surgery
(NCT05867342)
Timeframe: intraoperatively (up to 3 hours)
Intervention | minutes (Mean) |
---|
1:1000 Epinephrine Plus Saline | 72.05 |
1:1000 Epinephrine Plus Infiltration of 1% Lidocaine With 1:100,000 Epinephrine | 54.23 |
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Number of Extra Pledgets Used
A pledget is a small wad of absorbent material used to stop bleeding. (NCT05867342)
Timeframe: intraoperatively (up to 3 hours)
Intervention | pledgets (Mean) |
---|
1:1000 Epinephrine Plus Saline | 3.25 |
1:1000 Epinephrine Plus Infiltration of 1% Lidocaine With 1:100,000 Epinephrine | 2.63 |
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