Page last updated: 2024-12-05

epinephrine

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Description

ircinal A: from an Indonesian Acanthostrongylophora sponge with activity against infectious, tropical parasitic, and Alzheimer's diseases; structure in first source [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

Cross-References

ID SourceID
PubMed CID5270588
CHEMBL ID332054
SCHEMBL ID6007752
MeSH IDM0007583

Synonyms (5)

Synonym
ircinal a
ircinal
CHEMBL332054
SCHEMBL6007752
(1r,2r,4r,5z,12r,13s,16z)-13-hydroxy-11,22-diazapentacyclo[11.11.2.12,22.02,12.04,11]heptacosa-5,16,25-triene-25-carbaldehyde

Research Excerpts

Pharmacokinetics

ExcerptReferenceRelevance
" The potent antiinflammatory, antifungal, and anti-HIV-1 activity for a number of previously reported manzamines is also presented in addition to the pharmacokinetic studies of manzamine A (5)."( New manzamine alkaloids from an Indo-Pacific sponge. Pharmacokinetics, oral availability, and the significant activity of several manzamines against HIV-I, AIDS opportunistic infections, and inflammatory diseases.
Charman, WN; Hamann, MT; Hammond, NL; Mayer, AM; McIntosh, KA; Peng, J; Wahyuono, S; Yousaf, M, 2004
)
0.32

Bioavailability

ExcerptReferenceRelevance
" Oral and intravenous pharmacokinetic studies of manzamine A in rats indicated the compound to have low metabolic clearance, a reasonably long pharmacokinetic half-life, and good absolute oral bioavailability of 20."( New manzamine alkaloids from an Indo-Pacific sponge. Pharmacokinetics, oral availability, and the significant activity of several manzamines against HIV-I, AIDS opportunistic infections, and inflammatory diseases.
Charman, WN; Hamann, MT; Hammond, NL; Mayer, AM; McIntosh, KA; Peng, J; Wahyuono, S; Yousaf, M, 2004
)
0.32
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Bioassays (27)

Assay IDTitleYearJournalArticle
AID333077Cytotoxicity against african green monkey Vero cells at 4.7 ug/mL2004Journal of natural products, Aug, Volume: 67, Issue:8
Three new manzamine alkaloids from a common Indonesian sponge and their activity against infectious and tropical parasitic diseases.
AID1647725Antiproliferative activity against human C33A cells assessed as reduction in cell viability at 2 to 4 uM incubated up to 72 hrs by CellTiter-Glo assay
AID54866Inhibitory concentration against Cryptococcus neoformans; Not active2004Journal of medicinal chemistry, Jul-01, Volume: 47, Issue:14
New manzamine alkaloids from an Indo-Pacific sponge. Pharmacokinetics, oral availability, and the significant activity of several manzamines against HIV-I, AIDS opportunistic infections, and inflammatory diseases.
AID333080Antibacterial activity against Cryptococcus neoformans2004Journal of natural products, Aug, Volume: 67, Issue:8
Three new manzamine alkaloids from a common Indonesian sponge and their activity against infectious and tropical parasitic diseases.
AID144028Inhibitory concentration against Mycobacterium intracellular; Not active2004Journal of medicinal chemistry, Jul-01, Volume: 47, Issue:14
New manzamine alkaloids from an Indo-Pacific sponge. Pharmacokinetics, oral availability, and the significant activity of several manzamines against HIV-I, AIDS opportunistic infections, and inflammatory diseases.
AID333082Antiviral activity against HIV1 infected in human PBMCs2004Journal of natural products, Aug, Volume: 67, Issue:8
Three new manzamine alkaloids from a common Indonesian sponge and their activity against infectious and tropical parasitic diseases.
AID333079Antibacterial activity against methicillin-resistant Staphylococcus aureus2004Journal of natural products, Aug, Volume: 67, Issue:8
Three new manzamine alkaloids from a common Indonesian sponge and their activity against infectious and tropical parasitic diseases.
AID461357Antineuroinflammatory activity in LPS-stimulated rat neonatal microglia assessed as drug level causing 50% PMA-induced LDH release preincubated 15 mins prior to PMA challenge measured after 70 mins2010Journal of medicinal chemistry, Jan-14, Volume: 53, Issue:1
Structure-activity relationship and mechanism of action studies of manzamine analogues for the control of neuroinflammation and cerebral infections.
AID206709Inhibitory concentration against methicillin-resistant Staphylococcus aureus; Not active2004Journal of medicinal chemistry, Jul-01, Volume: 47, Issue:14
New manzamine alkaloids from an Indo-Pacific sponge. Pharmacokinetics, oral availability, and the significant activity of several manzamines against HIV-I, AIDS opportunistic infections, and inflammatory diseases.
AID1647728Antiproliferative activity against human CaSki cells assessed as reduction in cell viability at 2 to 4 uM incubated up to 72 hrs by CellTiter-Glo assay
AID333081Antibacterial activity against Mycobacterium intracellular2004Journal of natural products, Aug, Volume: 67, Issue:8
Three new manzamine alkaloids from a common Indonesian sponge and their activity against infectious and tropical parasitic diseases.
AID333072Antileishmanial activity against Leishmania donovani2004Journal of natural products, Aug, Volume: 67, Issue:8
Three new manzamine alkaloids from a common Indonesian sponge and their activity against infectious and tropical parasitic diseases.
AID1601819Antimycobacterial activity against Mycobacterium tuberculosis H37Rv2019European journal of medicinal chemistry, Mar-01, Volume: 165Marine natural products as potential anti-tubercular agents.
AID1647727Antiproliferative activity against human SiHa cells assessed as reduction in cell viability at 2 to 4 uM incubated up to 72 hrs by CellTiter-Glo assay
AID461356Antineuroinflammatory activity in LPS-stimulated rat neonatal microglia assessed as inhibition of PMA-induced TXB2 production preincubated 15 mins prior to PMA challenge measured after 70 mins2010Journal of medicinal chemistry, Jan-14, Volume: 53, Issue:1
Structure-activity relationship and mechanism of action studies of manzamine analogues for the control of neuroinflammation and cerebral infections.
AID206706Inhibitory concentration against Staphylococcus aureus; Not active2004Journal of medicinal chemistry, Jul-01, Volume: 47, Issue:14
New manzamine alkaloids from an Indo-Pacific sponge. Pharmacokinetics, oral availability, and the significant activity of several manzamines against HIV-I, AIDS opportunistic infections, and inflammatory diseases.
AID81266Effective concentration against HIV-12004Journal of medicinal chemistry, Jul-01, Volume: 47, Issue:14
New manzamine alkaloids from an Indo-Pacific sponge. Pharmacokinetics, oral availability, and the significant activity of several manzamines against HIV-I, AIDS opportunistic infections, and inflammatory diseases.
AID333078Antimicrobial activity against Staphylococcus aureus2004Journal of natural products, Aug, Volume: 67, Issue:8
Three new manzamine alkaloids from a common Indonesian sponge and their activity against infectious and tropical parasitic diseases.
AID1647726Antiproliferative activity against human HeLa cells assessed as reduction in cell viability at 2 to 4 uM incubated up to 72 hrs by CellTiter-Glo assay
AID1866011Cytotoxicity against mouse L1210 cells assessed as cell growth inhibition2022Bioorganic & medicinal chemistry, 01-15, Volume: 54Isolation and biological activity of azocine and azocane alkaloids.
AID754966Antihyperlipidemic activity in human MDM assessed as inhibition of acetylated LDL-induced [3H]-cholesterol ester accumulation at 20 uM after 24 hrs by radioscanner analysis in presence of [3H]-oleate-conjugated BSA2013Bioorganic & medicinal chemistry, Jul-01, Volume: 21, Issue:13
Manzamine A, a marine-derived alkaloid, inhibits accumulation of cholesterol ester in macrophages and suppresses hyperlipidemia and atherosclerosis in vivo.
AID377710Inhibition of human recombinant GSK3-beta assessed as incorporation of [33P]gammaATP into G2S peptide at 25 uM2006Journal of natural products, Jul, Volume: 69, Issue:7
Manzamine B and E and ircinal A related alkaloids from an Indonesian Acanthostrongylophora sponge and their activity against infectious, tropical parasitic, and Alzheimer's diseases.
AID333074Antimalarial activity against Plasmodium falciparum D6 at 5 ug/mL2004Journal of natural products, Aug, Volume: 67, Issue:8
Three new manzamine alkaloids from a common Indonesian sponge and their activity against infectious and tropical parasitic diseases.
AID333075Antimalarial activity against chloroquine-resistant Plasmodium falciparum W2 at 5 ug/mL2004Journal of natural products, Aug, Volume: 67, Issue:8
Three new manzamine alkaloids from a common Indonesian sponge and their activity against infectious and tropical parasitic diseases.
AID461355Antineuroinflammatory activity in LPS-stimulated rat neonatal microglia assessed as inhibition of PMA-induced superoxide anion production preincubated 15 mins prior to PMA challenge measured after 70 mins2010Journal of medicinal chemistry, Jan-14, Volume: 53, Issue:1
Structure-activity relationship and mechanism of action studies of manzamine analogues for the control of neuroinflammation and cerebral infections.
AID1865997Cytotoxicity against human KB cells assessed as cell growth inhibition2022Bioorganic & medicinal chemistry, 01-15, Volume: 54Isolation and biological activity of azocine and azocane alkaloids.
AID333069Antitubercular activity against Mycobacterium tuberculosis H37Rv2004Journal of natural products, Aug, Volume: 67, Issue:8
Three new manzamine alkaloids from a common Indonesian sponge and their activity against infectious and tropical parasitic diseases.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (9)

TimeframeStudies, This Drug (%)All Drugs %
pre-19900 (0.00)18.7374
1990's0 (0.00)18.2507
2000's3 (33.33)29.6817
2010's3 (33.33)24.3611
2020's3 (33.33)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials0 (0.00%)5.53%
Reviews3 (33.33%)6.00%
Case Studies0 (0.00%)4.05%
Observational0 (0.00%)0.25%
Other6 (66.67%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (524)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Comparison of Anaesthetic Effectiveness of Different Volumes of Articaine for Inferior Alveolar Nerve Block in Molar Teeth With Symptomatic Irreversible Pulpitis [NCT05840913]Phase 278 participants (Anticipated)Interventional2023-04-30Recruiting
Make up for the Epinephrine Autoinjector: Effect on Its Use by Untrained Users [NCT01217138]Phase 4164 participants (Actual)Interventional2009-06-30Completed
Bupivacaine in the Treatment of Postoperative Pain of Impacted Third Molar Extraction. A Randomized Clinical Trial. [NCT03950700]Phase 440 participants (Actual)Interventional2019-06-01Completed
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)Interventional2018-10-01Recruiting
Saline Injection - Assisted Anesthesia in Eyelid Surgery [NCT01239498]Phase 460 participants (Anticipated)Interventional2010-11-30Recruiting
Double-blind Comparison of Intrapleural Bupivacaine and Saline for Ipsilateral Shoulder Pain After Thoracotomy in Patients Receiving Thoracic Epidural Analgesia [NCT03862404]Phase 442 participants (Actual)Interventional2017-07-01Completed
Bupivacaine Versus Lidocaine Infiltration for Postoperative Pain in Thyroid Surgery: A Randomized Controlled Trial [NCT04427904]Phase 2210 participants (Anticipated)Interventional2022-06-01Recruiting
Endoscopic Injection of Autologous Blood Versus Diluted Epinephrine for Control of Actively Bleeding Gastroduodenal Ulcers [NCT01560702]100 participants (Actual)Interventional2012-03-31Completed
Application of Iced Normal Saline Combined With Cocktail Perfusion in Total Knee Arthroplasty: Randomized Controlled Trial [NCT05204056]60 participants (Actual)Interventional2018-03-02Completed
Post-cesarean Analgesia With Epidural Morphine Following Epidural 2-chloroprocaine [NCT04369950]Phase 444 participants (Actual)Interventional2020-05-11Completed
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)Interventional2018-01-01Completed
Ilioinguinal/Iliohypogastric vs. Quadratus Lumborum Nerve Blockade for Elective Open Inguinal Herniorrhaphy [NCT03007966]Phase 260 participants (Actual)Interventional2017-01-30Completed
Local Effects of Epinephrine on Lactate, Glucose, Lipid and Protein Metabolism in Bilaterally Perfused Human Legs [NCT01116609]10 participants (Actual)Interventional2004-10-31Completed
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)Interventional2010-05-31Recruiting
Hemostatic and Hemodynamic Effects of Intranasal Injection Compared to Topical Administration of Epinephrin in Endoscopic Sinus Surgery [NCT01075581]50 participants (Anticipated)Interventional2010-04-30Not 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 116 participants (Actual)Interventional2018-06-25Completed
ED50 and ED95 of Intrathecal Bupivacaine With or Without Epinephrine for Total Knee Replacement Arthroplasty [NCT01264575]162 participants (Actual)Interventional2009-12-31Completed
Study of Intracameral Adrenaline for Pupil Dilation Without Topical Mydriatics in Refractive Cataract Surgery [NCT01264653]60 participants (Actual)Interventional2010-12-31Completed
Combined Subconjunctival Atropine and Intracameral Epinephrine Injection for Pupil Dilation in Phacoemulsification Under Peribulbar Anesthesia. [NCT03638726]Phase 440 participants (Anticipated)Interventional2018-09-28Recruiting
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 2222 participants (Actual)Interventional2011-04-30Completed
Antecubital Versus Femoral Approach for Adrenal Venous Sampling: A Randomised Controlled Trial [NCT06029803]154 participants (Anticipated)Interventional2022-04-01Recruiting
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)Interventional2019-07-06Completed
Analgesic Efficacy of Liposomal Bupivacaine in Total Knee Arthroplasty [NCT02426164]Phase 40 participants (Actual)Interventional2015-06-30Withdrawn(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 4125 participants (Anticipated)Interventional2022-02-01Recruiting
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 434 participants (Actual)Interventional2015-05-31Completed
Pilot Study: Comparison of Buffered 1% vs. Unbuffered 2% Lidocaine in Pediatric Subjects; Clinical Outcomes [NCT03562481]Phase 426 participants (Actual)Interventional2018-07-24Completed
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 112 participants (Actual)Interventional2020-11-01Completed
Can Trajectory Nor-epinephrine Infiltration Reduce Blood Loss During Percutaneous Nephrolithotomy?: A Double-blind Randomized Placebo Controlled Study. [NCT05035303]140 participants (Actual)Interventional2020-03-10Completed
Role of Low Dose Epinephrine Boluses For Acute Hypotension in The Pediatrics ICU [NCT03671070]50 participants (Anticipated)Interventional2019-01-01Not yet recruiting
Randomized Trial Comparing Bupivacaine vs Lipossomic Extended Release Bupivacaine for Postoperative Pain Control After Minimally Invasive Thoracic Surgery [NCT03560362]Phase 1/Phase 250 participants (Anticipated)Interventional2015-07-09Recruiting
Towards Cost-effective Management of Patients With Hypertension Due to Primary Aldosteronism: Adrenal Vein Sampling or Ct-scan? [NCT01096654]Phase 3200 participants (Actual)Interventional2010-07-31Completed
The Application of Recombinant Human Hyaluronidase is Effective for the Use of Local Blocks for Eyelid Surgery [NCT02059694]0 participants (Actual)InterventionalWithdrawn
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 458 participants (Actual)Interventional2011-09-30Completed
Effect of Dexamethasone and Epinephrine on the Duration of Sciatic Nerve Blocks With Ropivacaine in Ankle and Foot Surgery [NCT02104778]90 participants (Anticipated)Interventional2014-04-30Recruiting
Randomized Clinical Trial to Verify the Effectiveness of Topical Aminocaproic Acid in the Prevention of Post-exodontic Bleeding in Patients on Anticoagulants [NCT02238288]Phase 4154 participants (Anticipated)Interventional2013-12-31Enrolling by invitation
Laparoscopically Guided Rectus Sheath Block in Pediatric Appendicitis - a Randomized Control Trial [NCT04717193]Phase 2100 participants (Anticipated)Interventional2021-05-28Recruiting
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)Interventional2019-06-26Recruiting
The Bupivacaine Dose Sparing Effect of Intrathecal Epinephrine for Spinal Anesthesia in Total Knee Replacement Arthroplasty [NCT01261078]75 participants (Anticipated)Interventional2010-12-31Completed
A Randomised Clinical Trial Comparing Endovenous Laser Ablation and Mechanochemical Ablation (ClariVein®) in the Management of Superficial Venous Insufficiency [NCT02627846]Phase 4150 participants (Actual)Interventional2015-06-01Completed
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 440 participants (Actual)Interventional2014-12-31Completed
The Effect of BMI on Median Effective Dose (ED50) of Intrathecal Hyperbaric Bupivacaine for Total Knee Replacement Arthroplasty [NCT01291186]108 participants (Actual)Interventional2010-01-31Completed
"The Effect Of Subcutaneous Epinephrine Dosage On Blood Loss In Surgical Incision" [NCT05670808]Phase 190 participants (Anticipated)Interventional2023-02-01Not 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 4137 participants (Actual)Interventional2011-04-30Completed
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 428 participants (Actual)Interventional2019-12-09Completed
Surgicel; a Probable Analgesic Reservoir for Post-laparoscopic Cholecystectomy Pain Management; Randomized Controlled Double-blind Trial [NCT03730714]Phase 2/Phase 390 participants (Actual)Interventional2018-11-15Completed
Tumescent Antibiotic Delivery for Prevention of Surgical Site Infection: A Multicenter Open Label Randomized Clinical Trial [NCT02503904]Phase 2/Phase 3400 participants (Anticipated)Interventional2015-10-31Not 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)Interventional2014-08-31Active, 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 4220 participants (Actual)Interventional2015-07-31Completed
Multimodal Nonopioid Pain Protocol Following Shoulder Arthroplasty Surgery [NCT05488847]Phase 480 participants (Anticipated)Interventional2022-06-25Recruiting
Role of Chemokine and Chemokine Receptor in Psoriasis [NCT03302390]0 participants (Actual)Observational2017-04-17Withdrawn(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 18 participants (Actual)Interventional2016-06-30Completed
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 460 participants (Actual)Interventional2017-02-25Completed
Phase III Study of Epinephrine Inhalation Aerosol for Evaluation of Efficacy and Safety of E004 in Children With Asthma [NCT01460511]Phase 370 participants (Actual)Interventional2011-10-31Completed
The Effect of Epinephrine, Norepinephrine and Phenylephrine on Intraoperative Hemodynamic Performance - a Prospective Double-blinded Randomized Clinical Trial [NCT05492968]Phase 4225 participants (Anticipated)Interventional2022-09-01Recruiting
The Effect of The Serratus Block on Analgesia After Breast Surgery A Randomized Controlled Double-Blinded Study [NCT02453516]Phase 2/Phase 340 participants (Actual)Interventional2014-10-29Completed
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)Interventional2023-01-04Active, not recruiting
The Effect of Intracameral Carbachol and Epinephrine Use on Choroidal Thickness After Uncomplicated Phacoemulsification [NCT05225597]81 participants (Actual)Interventional2021-01-01Completed
Managing Post Spinal Hypotension During Elective Cesarean Section: Epinephrine Versus Ephedrine, a Randomized Double-blinded Controlled Trial [NCT03704909]Phase 4143 participants (Actual)Interventional2018-09-01Completed
The Randomized Controlled Trial of Inferior Vena Cava Ultrasound-guided Fluid Management in Septic Shock Resuscitation [NCT03020407]211 participants (Actual)Interventional2017-01-18Completed
Management of Acute Pulmonary Hypertensive Crisis in Children With Known Pulmonary Arterial Hypertension [NCT05439460]Phase 415 participants (Actual)Interventional2012-01-31Completed
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 2243 participants (Actual)Interventional2017-01-14Completed
Effect of Local Infiltration Anesthesia With Ropivacaine on Pain After Primary Total Hip Arthroplasty [NCT02359136]116 participants (Actual)Interventional2013-03-31Completed
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 340 participants (Anticipated)Interventional2018-07-01Recruiting
"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)Interventional2014-10-15Completed
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)Interventional2022-06-22Recruiting
Ultrasound-Guided Versus Conventional Method for Caudal Block in Children [NCT03427437]275 participants (Actual)Interventional2017-02-01Completed
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 440 participants (Actual)Interventional2015-04-30Completed
Nebulized Hypertonic Saline (3%) Versus Nebulized Adrenaline for Treatment of Bronchiolitis: A Randomized Control Trial [NCT03614273]60 participants (Actual)Interventional2015-03-01Completed
A Prospective, Randomized Comparison Between Single and Double Injection Ultrasound-Guided Axillary Brachial Plexus Block [NCT02334176]320 participants (Anticipated)Interventional2015-01-31Not 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 1242 participants (Actual)Interventional2018-01-30Terminated(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)Interventional2021-03-01Withdrawn(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 425 participants (Anticipated)Interventional2018-01-03Not yet recruiting
WALANT Versus Axillary Brachial Plexus Block in Carpal Tunnel Release: a Non-inferiority Randomized Controlled Trial [NCT06040840]130 participants (Anticipated)Interventional2023-11-01Not 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 475 participants (Actual)Interventional2014-02-28Completed
Efficacy of Lidocaine Saline Irrigation in Patients Undergoing Shoulder Arthroscopy: Randomized Controlled Study [NCT05624957]50 participants (Actual)Interventional2022-11-25Completed
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 424 participants (Anticipated)Interventional2019-07-02Recruiting
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 29 participants (Actual)Interventional2009-12-31Terminated(stopped due to Optimization of protocol)
Evaluation of Cardiac Arrhythmias in Patients Undergoing Kidney Cancer Surgery Depending on the Anaesthesia Method [NCT02988219]Phase 450 participants (Actual)Interventional2010-06-30Completed
Prospective Randomized Clinical Trial to Evaluate the Use of Caudal Nerve Blocks in Adult Penile Prosthesis Surgery [NCT02740127]Phase 352 participants (Actual)Interventional2016-06-30Completed
Influence of Synacthen Infusion on the Results of Adrenal Venous Sampling in Patient With Primary Aldosteronism [NCT02127840]Phase 440 participants (Anticipated)Interventional2011-03-31Recruiting
Phase II Clinical Trial for a Stepwise Progression in the Treatment of Cardiogenic Shock [NCT02591771]Phase 224 participants (Actual)Interventional2015-10-31Completed
Magnesium-sulfate as Adjuvant in Prehospital Femoral Nerve Block for Patient With Diaphysial Femoral Fracture: a Randomized Controlled Trial [NCT03597945]48 participants (Actual)Interventional2015-04-30Completed
Bacteriostatic Saline as a Local Anesthetic in Minor Eyelid Procedures [NCT05294640]Phase 495 participants (Actual)Interventional2022-05-17Completed
Pharmacokinetic Study of Epinephrine During Cardiac Arrest Determining T1/2 and Time to Peak Concentration [NCT03036202]8 participants (Actual)Observational2017-06-26Completed
Is the Direct Inferior Alveolar Nerve Block Required for Third Lower Molar Extraction? [NCT03443726]120 participants (Actual)Interventional2017-06-10Completed
Three-level Injection Paravertebral Block Using Paravertebral Catheter Compared to General Anesthesia in Mastectomy Surgery [NCT02065947]Phase 1/Phase 260 participants (Actual)Interventional2013-10-31Completed
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)Interventional2018-06-01Completed
Randomized Clinical Trial Examining Use of Adjunct EXPAREL for Post-tonsillectomy Pain Management in Adults [NCT03420638]Phase 438 participants (Anticipated)Interventional2018-02-15Recruiting
Effect of Local Infiltration Anesthesia in a Hip Arthroplasty Fast Track Program. [NCT03513276]Phase 463 participants (Actual)Interventional2016-02-29Completed
Bacteraemia Secondary to Tooth Extraction: a Randomized Clinical Trial on Efficacy of Three Different Chlorhexidine Prophylaxis Protocols [NCT02150031]Phase 4208 participants (Actual)Interventional2010-12-31Completed
Epinephrine Inhalation Aerosol USP, an HFA-MDI: Clinical Study-C For Evaluation Of Efficacy And Safety In Asthma Patients [NCT01357642]Phase 3373 participants (Actual)Interventional2011-07-31Completed
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 3208 participants (Actual)Interventional2011-11-30Completed
Usage of Tranexamic Acid During Colonic Endoscopic Resection Procedures for Reduction Intraprocedural and Postprocedural Bleeding [NCT05345613]Phase 4200 participants (Anticipated)Interventional2022-05-01Recruiting
Effect of Lidocaine/Dexamethasone on the Success of IANB in Patients With Irreversible Pulpitis [NCT03531970]Phase 2/Phase 3100 participants (Actual)Interventional2016-08-01Completed
Photobiomodulation for Controlling Pre-Local Anesthetic Injection Pain: A Double-Blind, Randomized Controlled Clinical Study [NCT06128590]50 participants (Anticipated)Interventional2023-11-15Not 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 456 participants (Actual)Interventional2015-08-31Completed
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 290 participants (Anticipated)Interventional2019-01-15Recruiting
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)Interventional2022-05-25Recruiting
Quadratus Lumborum Block Versus Control for Total Hip Arthroplasty [NCT03408483]Phase 2/Phase 380 participants (Actual)Interventional2018-04-01Completed
Randomized, Double Blind Trial of Thoracolumbar Interfascial Plane Block and Erector Spinae Plane Block for Adult Spinal Surgery [NCT03931343]60 participants (Anticipated)Interventional2020-12-31Not yet recruiting
Local Infiltration Analgesia During Total Knee Arthroplasty - Reduced Opiate Consumption and Faster Mobilisation Postoperatively - Randomized Controlled Trial [NCT01305733]60 participants (Actual)Interventional2011-03-31Active, not recruiting
Low Dose EPInephrine to Improve Platelet Reactivity in TICagrelor-treated Subjects: A Proof of Concept Study in Healthy Volunteers (EPITIC) [NCT03441412]Phase 110 participants (Actual)Interventional2018-02-28Completed
Adrenal Venous Sampling Via an Antecubital Approach: A Multicenter Study [NCT03778645]1,500 participants (Anticipated)Observational2018-07-01Recruiting
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 328 participants (Actual)Interventional2012-10-31Completed
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 357 participants (Actual)Interventional2018-07-05Completed
How Successful is Supplemental Intraseptal Anaesthesia in Patients With Mandibular Teeth Extraction or Irreversible Pulpitis [NCT03880409]Phase 1100 participants (Actual)Interventional2019-02-09Completed
Role of Platelet Rich Plasma in the Treatment of Actively Bleeding Peptic Ulcer [NCT03733171]80 participants (Anticipated)Interventional2018-09-20Recruiting
Effect of Buffered Lidocaine With Epinephrine in Local Anesthesia During Subcutaneous Implantable Venous Access Devices Insertion: Double Blind Randomized Study. [NCT03628430]120 participants (Actual)Interventional2017-01-01Completed
ENHANCED RECOVERY AFTER ORTHOGNATHIC SURGERY USING LIPOSOMAL BUPIVACAINE: A RANDOMIZED CONTROL TRIAL [NCT03844451]Phase 475 participants (Anticipated)Interventional2019-05-17Recruiting
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)Interventional2020-09-11Completed
Formulations of Liposomal Local Anesthetics for Dental Anesthesia [NCT01307969]Phase 140 participants (Actual)Interventional2007-02-28Completed
Comparison of Postoperative Pain With Two Different Types of Local Anesthesia in Surgery for a Drooping Eyelid [NCT01350024]34 participants (Actual)Interventional2011-05-01Completed
[NCT02864095]200 participants (Anticipated)Interventional2015-05-31Recruiting
A Prospective, Randomized, Controlled Trial of Combination Vasopressin and Epinephrine to Epinephrine Only for In-Intensive Care Unit Pediatric Cardiopulmonary Resuscitation [NCT00628550]Phase 1130 participants (Anticipated)Interventional2008-04-30Completed
A Randomized, Prospective Trial Comparing Peri-articular Injection Utilizing a Pain Cocktail With and Without Exparel [NCT02571283]Phase 40 participants (Actual)Interventional2015-10-31Withdrawn(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 4300 participants (Anticipated)Interventional2019-10-01Enrolling by invitation
Hypoglycemia Associated Autonomic Failure in Type 1 DM, Question 5 [NCT00605774]0 participants (Actual)InterventionalWithdrawn
Hypoglycemia Associated Autonomic Failure in Type 1 DM, Question 4 [NCT00608816]0 participants (Actual)InterventionalWithdrawn
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)Interventional2018-09-14Terminated(stopped due to Recruitment issues)
Intraoperative Use of Perineal Block for Hemorrhoidectomy [NCT04288349]100 participants (Anticipated)Interventional2020-02-20Recruiting
Efficacy and Safety of Periarticular Multimodal Drug Injections in Total Knee Arthroplasty [NCT00901628]Phase 4101 participants (Actual)Interventional2008-04-30Completed
[NCT02839356]Phase 4670 participants (Anticipated)Interventional2016-07-31Recruiting
Multimodal Drug Infiltration in Total Knee Arthroplasty: Is Posterior Capsular Infiltration Worth the Risk? A Prospective, Double-Blind, Randomized Controlled Trial [NCT02860949]Phase 290 participants (Actual)Interventional2014-04-30Completed
[NCT02807298]Phase 325 participants (Actual)Interventional2014-06-30Completed
A Randomized, Single-Blinded, Placebo-Controlled Study Evaluating Postoperative Non-Opioid Pain Management Utilizing Local Anesthetics Coupled With Modulated Coagulation [NCT04814433]Phase 45 participants (Actual)Interventional2021-03-24Terminated(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 380 participants (Actual)Interventional2013-02-28Completed
Occurrence of Heart Arrhythmia During Restorative Dental Procedure Under Local Anesthesia , in Heart Failure Pacients. A Double-blind Study [NCT02228083]70 participants (Anticipated)Interventional2014-09-30Recruiting
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)Interventional2014-08-31Withdrawn(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 3100 participants (Actual)Interventional2017-07-01Completed
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)Interventional2013-01-31Recruiting
Shamrock Versus Lumbar Ultrasound Trident - Ultrasound Guided Block of the Lumbar Plexus: A Randomized Controlled Trial [NCT02255591]Phase 420 participants (Actual)Interventional2015-02-28Completed
Analgesic Benefit of PECS Blocks for Biceps Tenodesis Shoulder Surgery [NCT02741713]Phase 340 participants (Actual)Interventional2016-04-30Completed
Double-Blinded Randomized Controlled Study Investigating the Efficacy of Exparel (Liposomal Bupivacaine) for Postoperative Pain Relief in Mandibular Third Molar Extractions [NCT05374499]Phase 440 participants (Anticipated)Interventional2022-09-01Active, not recruiting
Fractional Carbon Dioxide Laser Assisted Delivery of Topical Anesthetics: a Randomized Controlled Pilot Study [NCT02246179]Phase 410 participants (Actual)Interventional2014-09-30Completed
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)Interventional2015-07-31Completed
High Volume, Multilevel Local Anesthetic-Epinephrine Infiltration in Kyphoscoliosis Surgery: Blood Conservation and Analgesia [NCT03319563]52 participants (Actual)Interventional2017-04-11Completed
The Effect of Adding Nebulized Epinephrine in Asthma Exacerbation Management in Pediatric Age Group Compared to Standard of Care: Superiority Trial [NCT05667727]Phase 430 participants (Anticipated)Interventional2023-10-15Recruiting
Periarticular Bupivacaine + Meloxicam ER Solution Versus Standard Practice During Total Knee Arthroplasty: A Single Institution, Single-blinded, Randomized Clinical Trial [NCT05188053]Phase 498 participants (Anticipated)Interventional2022-02-07Enrolling 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 115 participants (Actual)Interventional2021-08-09Completed
Efficacy of Peri-Incisional Multimodal Drug Injection Following Operative Management of Femur Fractures: A Randomized Controlled Trial [NCT02793947]Phase 4102 participants (Actual)Interventional2015-05-31Completed
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)Interventional2023-12-31Not yet recruiting
Efficacy of Multimodal Periarticular Injections in Operatively Treated Ankle Fractures: A Randomized Controlled Trial [NCT02967172]Phase 4100 participants (Actual)Interventional2016-10-31Completed
[NCT02135627]20 participants (Actual)Interventional2014-04-30Completed
Efficacy of Adrenaline in Periarticular Analgesic Injection on Postoperative Pain Control After Total Knee Arthroplasty: A Randomized Controlled Trial [NCT03549221]Phase 282 participants (Anticipated)Interventional2018-01-26Recruiting
Epinephrine Self-injection and Self-management of Food Allergies [NCT02417493]60 participants (Actual)Interventional2015-03-31Completed
Bilateral Paravertebral Blockade for Improvement of Quality of Recovery Following Cardiac Surgery (P-QOR): a Randomized Controlled Trial [NCT06008821]224 participants (Anticipated)Interventional2023-09-30Not yet recruiting
Postoperative Pain Management Following Total Hip Arthroplasty. A Comparison Between Local Infiltration Analgesia and Ultrasound Guided 3-in-1 Block [NCT02568995]Phase 355 participants (Actual)Interventional2014-05-31Completed
Assessment of Airway Obstruction in Infants With Lower Respiratory Infections [NCT00435994]59 participants (Actual)Interventional2003-12-31Completed
Tumescent Lidocaine Bioavailability and Absorption Kinetics:Maximum Safe mg/kg Lidocaine Dosage [NCT00977028]Phase 1/Phase 214 participants (Actual)Interventional2005-01-31Enrolling by invitation
Awake Caudal Catheter Infusion Versus General Anesthesia and Single-dose Caudal Injection for Preterm NICU Patients Undergoing Inguinal Herniorraphy. [NCT05919732]Phase 440 participants (Actual)Interventional2016-03-08Completed
Can Epinephrine Coated Syringe for Subcutaneous Immunotherapy (SCIT) Reduce Large Local Reaction? [NCT03963115]Phase 1/Phase 217 participants (Actual)Interventional2018-10-24Completed
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 2138 participants (Actual)Interventional2007-06-30Completed
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)Observational2021-10-01Recruiting
Local Infiltration Analgesia With Ropivacaine, Ketorolac and Epinephrine Intra- and Postoperatively in Total Knee Arthroplasty [NCT00799175]48 participants (Actual)Interventional2007-04-30Completed
Local Infiltration Analgesia or Intrathecal Morphine in Total Knee Arthroplasty [NCT00992082]50 participants (Anticipated)Interventional2009-08-31Recruiting
Effectiveness of Caudal Epidural Block on Intraoperative Blood Loss During Hypospadias Repair; A Randomized Clinical Trial [NCT02752308]Phase 2/Phase 360 participants (Actual)Interventional2014-09-30Completed
Platform Adaptive Embedded Trial for Acute Respiratory Distress Syndrome [NCT05658692]Phase 41,000 participants (Anticipated)Interventional2022-10-01Recruiting
Comparison of Perioperative Opioid Consumption Following Pectoral Nerve Block Under General Anesthesia for Breast Cancer Surgery: A Randomized Clinical Trial [NCT02741232]50 participants (Actual)Interventional2016-03-31Completed
The Use of Tranexamic Acid in Irrigation Fluid to Improve Arthroscopic Visualization in Shoulder Surgery: A Randomized Controlled Trial [NCT04594408]Phase 4128 participants (Actual)Interventional2020-09-01Active, 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)Interventional2016-11-15Completed
Efficacy of Multimodal Peri- and Intraarticular Drug Injections in Total Knee Arthroplasty [NCT00562627]Phase 4102 participants (Actual)Interventional2007-11-30Completed
Interest of the Alkalinization of the Adrenaline Lidocaine Solution for Conversion of Epidural Analgesia Into Epidural Anesthesia During an Emergency Caesarean [NCT04255121]Phase 3400 participants (Actual)Interventional2020-06-22Completed
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 3135 participants (Anticipated)Interventional2021-08-17Recruiting
Effect of Intrapartum Epidural Fentanyl Upon Breastfeeding in the Immediate Postpartum Period: a Randomized, Controlled, Double-blinded Study [NCT01497509]0 participants (Actual)Interventional2012-05-31Withdrawn(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)Interventional2016-08-31Recruiting
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 465 participants (Actual)Interventional2014-12-31Completed
The Influence of Local Infiltration Analgesia by Catheter in Postoperative Control Pain After Total Hip Replacement [NCT02630160]Phase 4100 participants (Actual)Interventional2013-03-31Completed
A Novel Method for Chronic Anal Fissure Treatment: Adipose Derived Regenerative Cells - A Pilot Study [NCT02628522]6 participants (Actual)Interventional2014-12-31Completed
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 163 participants (Anticipated)Interventional2023-10-23Not 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 280 participants (Anticipated)Interventional2019-09-25Recruiting
The Efficacy of Liposomal Bupivacaine in the Management of Post-operative Pain Following Septorhinoplasty: A Double-blinded, Prospective Clinical Trial [NCT05964868]Phase 372 participants (Anticipated)Interventional2024-01-31Not 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)Observational2022-06-03Recruiting
The Effects of Hydrocortisone in Endotoxemia in Normal Volunteers [NCT01064986]Phase 112 participants (Actual)Interventional2010-02-28Completed
Analgesic Efficacy of Intravenous Lidocaine for Postoperative Pain Following Adult Spine Surgery: A Randomized Controlled Trial [NCT01043211]0 participants (Actual)Interventional2012-01-31Withdrawn(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)Interventional2010-03-31Completed
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 3224 participants (Actual)Interventional2015-09-07Completed
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)Interventional2015-08-31Completed
Double Blinded Controled Study:Treatment With Adrenaline Inhalation Versus Nasal Decongestant Drops for Bronchiolitis [NCT00622817]65 participants (Actual)Interventional2004-10-31Completed
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)Interventional2016-01-31Completed
A Phase 1 Comparative Bioavailability Study of Inhaled Epinephrine and Intramuscular Epinephrine Administered to Healthy Adults [NCT05152901]Phase 123 participants (Actual)Interventional2022-01-06Completed
Intraoperative Injection of Exparel Effect on Postoperative Opioid Use in Thyroid and Parathyroid Surgery [NCT04085913]Early Phase 1100 participants (Anticipated)Interventional2019-09-30Enrolling 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)Interventional2023-02-12Recruiting
Effects of Pre-emptive Scalp Infiltration With Ketorolac and Ropivacaine for Postoperative Pain Relief After Elective Supratentorial Craniotomy (PAINLESS) [NCT04141319]Phase 4100 participants (Anticipated)Interventional2021-12-31Not 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)Interventional2015-10-31Completed
Dynamics and State Transitions During Resuscitation in In-hospital Cardiac Arrest [NCT00920244]285 participants (Actual)Observational2009-08-31Completed
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)Interventional2008-09-30Terminated(stopped due to Prohibitively expensive and efficacy of tranexamic acid rendered topic clinically less relevant.)
[NCT02593370]Phase 126 participants (Actual)Interventional2015-10-31Completed
Articaine Efficacy and Safety in Young Children Below Age of Four Years: An Equivalent Parallel Randomized Control Trial [NCT04061265]Phase 1/Phase 2184 participants (Actual)Interventional2019-08-25Completed
Prospective, Randomized Trial of Hemospray Plus Epinephrine Injection Versus Endoscopic Hemoclip Plus Epinephrine Injection in Nonvariceal Upper Gastrointestinal Bleeding [NCT02537353]Phase 440 participants (Anticipated)Interventional2015-09-30Not yet recruiting
Study of Tramadol Addiction Impact on Dental Anesthesia Succes. [NCT05908305]Phase 4300 participants (Anticipated)Interventional2023-06-10Not yet recruiting
Electromechanical Profiling of Arrhythmogenic Substrates and Triggers in the Long-QT Syndrome [NCT04074122]150 participants (Anticipated)Observational2020-01-01Not yet recruiting
Vasopressin, Epinephrine, and Corticosteroids for Inhospital Cardiac Arrest: A Multicenter Randomized Controlled Trial [NCT00729794]Phase 3300 participants (Actual)Interventional2008-09-30Completed
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 290 participants (Anticipated)Interventional2009-05-31Completed
Mechanisms of Hypoglycemia Associated Autonomic Failure [NCT00678145]Phase 2116 participants (Anticipated)Interventional2008-03-31Active, not recruiting
Fractional CO2 Laser Assisted Topical Articaine Anesthesia vs. Topical EMLA Administration: a Randomized Controlled Study [NCT02548533]Phase 43 participants (Actual)Interventional2015-06-30Terminated(stopped due to Not enough patients eligible for recruitment.)
Evidence of Spreading Vasoconstriction in Human Gingiva [NCT04131283]29 participants (Actual)Interventional2019-05-01Completed
Shamrock - Ultrasound/MR Image Fusion Guided Lumbar Plexus Block [NCT02718976]Phase 222 participants (Actual)Interventional2016-03-31Completed
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)Interventional2022-01-01Enrolling 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)Interventional2017-02-01Completed
The Effects of Epinephrine in Endotoxemia in Normal Volunteers [NCT00753402]Phase 137 participants (Actual)Interventional2012-02-29Completed
Anesthetic Efficacy of %4Alexadricaine Versus %2 Mepicaine-L for Infiltration Anesthesia in Extraction of Maxillary First Primary Molars in Children [NCT04477317]Phase 310 participants (Actual)Interventional2021-08-01Completed
Adrenal Venous Sampling in Patients With Overt or Subclinical Cushings Syndrome, and Bilateral Adrenal Tumors [NCT02543697]30 participants (Anticipated)Interventional2015-02-28Recruiting
Periarticular Injection and Hamstring Block Versus Placebo for Pain Control in Anterior Cruciate Ligament Reconstruction: A Randomized Controlled Trial [NCT05248724]44 participants (Actual)Interventional2017-08-01Completed
The Use of Epinephrine Infusion for Prophylaxis Against Maternal Hypotension During Cesarean Delivery: a Randomized Controlled Dose-finding Trial [NCT05051150]Phase 418 participants (Actual)Interventional2021-09-15Terminated(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 3854 participants (Actual)Interventional2018-09-18Completed
Prospective Evaluation of Topical Analgesia Using a Lidocaine/Prilocaine Cream for Laceration Repair in the Emergency Department [NCT03071601]Phase 4132 participants (Actual)Interventional2017-12-01Completed
Surgery of Subclinical Cortisol Secreting Adrenal Incidentalomas [NCT02364089]78 participants (Actual)Interventional2015-04-09Completed
Effect of Chronic Catecholamine Overproduction on Brown Adipose Tissue [NCT01949714]10 participants (Actual)Observational2013-08-31Completed
Buffered vs. Unbuffered Local Anesthesia in Mandibular Molars Diagnosed With Symptomatic Irreversible Pulpitis: A Controlled, Randomized Double-blind Study [NCT05227300]Phase 440 participants (Anticipated)Interventional2022-02-14Recruiting
The Hemostatic and Hemodynamic Effects of Adrenaline During Endoscopic Sinus Surgery: Randomized Clinical Trial [NCT00852410]Phase 3140 participants (Anticipated)Interventional2009-03-31Not 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 2100 participants (Anticipated)Interventional2015-11-30Not yet recruiting
Pharmacokinetic Interaction Effects of Combined Fentanyl and Adrenalin in Epidural Analgesia During Child Birth [NCT00685672]Phase 440 participants (Actual)Interventional2008-08-31Completed
Duration of Blockade of Peripheral Nerves With Low Concentrated Bupivacaine Solution Depending of the Adjuvants [NCT04498923]68 participants (Actual)Observational2018-01-01Completed
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 432 participants (Actual)Interventional2018-07-02Completed
"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)Interventional2020-08-27Completed
Intraoperative Angiotensin 2 for the Prevention of Kidney Injury After Liver Transplant [NCT04592744]Phase 430 participants (Anticipated)Interventional2022-04-08Enrolling by invitation
A Randomized Double Blind Trial of Vasoactive Drugs for the Management of Shock in the ICU [NCT02118467]Phase 4836 participants (Anticipated)Interventional2014-05-31Recruiting
Prospective, Multicenter, Randomized, Double-Blind Study Comparing Safety and Efficacy of Norepinephrine Plus Dobutamine Versus Epinephrine Alone in Septic Shock. [NCT00148278]Phase 2/Phase 3330 participants (Actual)Interventional1999-10-31Completed
Nebulized Adrenalin and Oral Betamethasone in Children With Bronchiolitis Attending Pediatric Emergencies : a Multicentre Randomized Controlled Trial [NCT02586961]Phase 2/Phase 3195 participants (Actual)Interventional2015-10-31Terminated(stopped due to Removal of Adrénaline lots for safety reasons.)
7% Hypertonic Saline for Acute Bronchiolitis: A Randomized Controlled Trial [NCT01871857]Phase 4101 participants (Actual)Interventional2010-11-30Completed
Comparative Evaluation of Handling Characteristics of Two Adrenaline Autoinjectors,EpiPen in Comparison With Jext; the HEJ-study [NCT01887405]Phase 491 participants (Actual)Interventional2012-01-31Completed
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)Interventional2008-08-31Completed
Bronchiolitis All-study, SE-Norway What is the Optimal Inhalation Treatment for Children 0-12 Months With Acute Bronchiolitis? [NCT00817466]Phase 4500 participants (Anticipated)Interventional2010-01-31Active, not recruiting
The Effects of Epinephrine and Cortisol on Emotion in Depression [NCT04148261]Early Phase 10 participants (Actual)Interventional2020-12-31Withdrawn(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 4187 participants (Actual)Interventional2007-04-30Completed
High Flow Therapy vs Hypertonic Saline in Bronchiolitis Treatment. Randomized Controlled Trial [NCT01873144]Phase 375 participants (Actual)Interventional2010-10-31Completed
The Efficacy of Analgesic Buffering With Sodium Bicarbonate for the Pediatric Dental Patient [NCT01883232]0 participants (Actual)Interventional2013-08-31Withdrawn
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 2100 participants (Actual)Interventional2006-06-30Completed
An Ultrasound Guided Fascia Iliaca Block Placed at the Level of the Inguinal Ligament for Analgesia After Hip Arthroplasty [NCT01911949]24 participants (Actual)Interventional2017-01-31Completed
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 450 participants (Actual)Interventional2010-02-28Completed
Effect of Preventive Medicine on the Postreperfusion Syndrome [NCT01080625]96 participants (Actual)Interventional2010-04-30Completed
Efficiency of Multi-Modal Anesthesia (MMA) Protocol in Pain Control and Analgesia in Patients Undergoing Posterior Lumbar Spinal Fusion Surgery [NCT05413902]Phase 4100 participants (Actual)Interventional2021-04-05Completed
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 488 participants (Anticipated)Interventional2017-04-01Active, 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 460 participants (Actual)Interventional2013-03-31Completed
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 430 participants (Actual)Interventional2013-08-31Completed
An Evaluation of Post Caesarean-Section Pain Control Regimens: Non-Opioid Oral Regimen With and Without Transversus Abdominis Plane Block [NCT01982929]180 participants (Actual)Interventional2013-11-30Completed
Can we Gain an Advantage by Combining Distal Median, Radial and Ulnar Nerve Blocks With Supraclavicular Block? A Randomized Controlled Study [NCT01989312]Phase 475 participants (Actual)Interventional2012-02-29Completed
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 420 participants (Actual)Interventional2012-11-30Completed
Regional Anesthesia Block of the Transversus Abdominis Plane in Children Undergoing Gastric Tube Insertion [NCT00564655]Phase 33 participants (Actual)Interventional2007-10-31Terminated
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)Interventional2012-01-31Completed
Effects of Adrenaline Infiltration on Surgical Field of View in Endoscopic Sinus Surgery [NCT05867342]Phase 440 participants (Actual)Interventional2017-05-12Completed
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 290 participants (Anticipated)Interventional2020-10-15Recruiting
Comparison Between Effect of Adrenaline and Without Adrenaline in Tumescent Solutions on Bleeding Control of Skin Graft Donor Site. [NCT04590638]56 participants (Actual)Interventional2020-10-17Completed
Comparison of Ropivacaine Plasma Concentration With or Without Epinephrine for Posterior Quadratus Lumborum Block in Cesarean Section [NCT04562103]52 participants (Actual)Interventional2020-07-03Completed
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)Interventional2012-08-31Withdrawn(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)Interventional2023-02-01Recruiting
Randomized, Double-Blind, Placebo-Controlled Study of Effects of Combined Spinal Epidural Analgesia on Intrapartum Fever. [NCT00802646]0 participants (Actual)Interventional2009-06-30Withdrawn(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 3135 participants (Anticipated)Interventional2014-08-31Recruiting
Prophylactic Racemic Epinephrine for the Prevention of Dysphagia in Patients Undergoing Anterior Cervical Discectomy and Fusion: A Randomized Control Trial [NCT02724761]90 participants (Anticipated)Interventional2016-09-30Not yet recruiting
A Prospective Randomized Case Series Comparison on the Clinical Efficacy of Exparel Local Anesthetic in Total Knee Arthroplasty Patients [NCT02765815]Phase 40 participants (Actual)Interventional2016-02-29Withdrawn(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)Interventional2016-01-19Recruiting
The Effect of Subsartorial Saphenous Block on Postoperative Pain Following Major Ankle and Hind Foot Surgery [NCT02697955]Phase 418 participants (Actual)Interventional2016-06-21Completed
[NCT02860221]210 participants (Anticipated)Interventional2015-05-31Recruiting
Ophthalmic Artery Resistance Index After Peribulbar Block in the Presence of Epinephrine [NCT04153123]26 participants (Actual)Interventional2013-12-01Completed
Topical Use of Tranexamic Acid Versus Epinephrine to Optimize Surgical Field During Exploratory Tympanotomy [NCT04188184]60 participants (Actual)Interventional2019-12-04Completed
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 430 participants (Actual)Interventional2010-12-31Completed
Comparison of the Efficacy and Safety of Two Homologous Active Principles for Local Dental Anesthesia: Non-inferiority Trial [NCT04166890]Phase 4179 participants (Actual)Interventional2018-09-04Completed
Local Infiltration Analgesia (LIA) With Ropivacaine, Ketorolac and Epinephrine Intra- and Postoperatively in Unicompartmental Knee Arthroplasty [NCT00653926]40 participants (Actual)Interventional2005-09-30Completed
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)Interventional2006-11-30Completed
An Assessment of the Effects of Pressors on Graft Blood Flow After Free Tissue Transfer Surgery: A Randomised Study [NCT01418118]Phase 425 participants (Actual)Interventional2008-10-31Completed
Comparison of Absorption of Epinephrine Into the Circulation After Epinephrine Intranasal Spray Administration and After Intramuscular Injection [NCT01432522]12 participants (Anticipated)Interventional2010-07-31Completed
Pectoral Nerve (PECS) Block for Cardiac Implantable Electronic Devices (CIED) Implantation Surgery [NCT04577690]Phase 448 participants (Anticipated)Interventional2019-12-01Recruiting
Prophylactic Tranexamic Acid Versus Adrenaline for Bleeding Prevention During Flexible Bronchoscopy: a Double Blind, Randomized Controlled Trial [NCT06145191]840 participants (Anticipated)Interventional2023-12-18Recruiting
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 221 participants (Actual)Interventional2012-11-30Terminated(stopped due to unable to validate analytical method)
"The Efficacy of Exparel Versus a Multidrug Cocktail in Soft Tissue Tumors" [NCT05355597]Phase 2140 participants (Anticipated)Interventional2021-01-27Recruiting
Effect of Local Infiltration Anesthesia With Ropivacaine on Postoperative Pain After Hip Hemiarthroplasty [NCT02585011]123 participants (Actual)Interventional2015-12-31Completed
Myocardial Deformation Before and After Birth, and Under Altered Preload, Afterload and Heart Rate in New-borns [NCT04060381]300 participants (Anticipated)Observational2017-04-04Active, 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)Interventional2023-06-05Not yet recruiting
Subacromial Injection of Epinephrine Improves Visualization in Shoulder Arthroscopy [NCT05244525]Phase 460 participants (Actual)Interventional2022-03-14Completed
Use of Vasopressin Versus Epinephrine to Reduce Hemorrhage During Myomectomy: a Randomized Controlled Trial [NCT01861015]Phase 360 participants (Actual)Interventional2013-05-31Completed
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 4150 participants (Actual)Interventional2016-12-01Completed
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)Interventional2022-03-04Recruiting
Pharmacokinetics and Pharmacodynamics for Levobupivacaine With and Without Epinephrine After Ultrasound Guided Erector Spinae Plane Block [NCT04799184]Phase 438 participants (Anticipated)Interventional2019-04-03Recruiting
Postoperative Pain Control Using Local Wound Infiltration in Adolescent Idiopathic Surgery: A Randomized Control Trial [NCT04730531]100 participants (Anticipated)Interventional2022-06-02Recruiting
Low-dose Epinephrine Infusion Tests in Adolescent and Pediatric Patients [NCT00548886]7 participants (Actual)Interventional2008-02-29Terminated(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)Interventional2018-01-02Completed
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 40 participants (Actual)Interventional2016-01-31Withdrawn
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 4201 participants (Actual)Interventional2021-01-01Completed
Adrenal Scans With Radioiodine-Labeled Norcholesterol (NP-59) [NCT00591643]Phase 193 participants (Actual)Interventional1977-07-31Completed
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 260 participants (Actual)Interventional2010-01-31Completed
Maternal-Fetal Monitoring of Patients With Rheumatic Heart Disease During Dental Procedure Under Local Anesthesia [NCT00482573]Phase 131 participants (Actual)Interventional2004-04-30Completed
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 1200 participants (Anticipated)Interventional2021-05-15Enrolling by invitation
Comparative Effect of Palatal Injection on Pain Perception in Pediatric Patient [NCT06025825]96 participants (Anticipated)Observational [Patient Registry]2023-05-02Recruiting
Epinephrine Versus Phenylephrine Infusion for Prophylaxis Against Maternal Hypotension After Spinal Anesthesia for Cesarean Delivery: a Randomized Controlled Trial. [NCT05881915]196 participants (Anticipated)Interventional2023-06-01Recruiting
Intercostal Cryoneurolysis Following Traumatic Rib Fractures [NCT04198662]Phase 420 participants (Actual)Interventional2020-04-03Active, not recruiting
Parameters in Fractional Laser Assisted Delivery of Topical Anesthetics: Role of Laser Type and Laser Settings [NCT02938286]Phase 415 participants (Actual)Interventional2016-03-31Completed
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)Interventional2016-05-23Completed
Cardiovascular Effects of Racemic Epinephrine Pellets Used in Pediatric Restorative Dentistry Under General Anesthesia [NCT04688346]Phase 2/Phase 313 participants (Actual)Interventional2019-06-10Completed
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)Interventional2021-06-01Completed
The Use of Lidocaine Ophtesic Gel Versus Subconjunctival Xylocaine Injection in Pterygium Excision [NCT05978687]Phase 450 participants (Anticipated)Interventional2023-09-01Recruiting
A Randomized Controlled Trial Comparing Epinephrine and Dexamethasone to Placebo in the Treatment of Infants With Bronchiolitis [NCT03567473]Phase 3864 participants (Anticipated)Interventional2018-12-13Recruiting
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 233 participants (Actual)Interventional2008-02-29Completed
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 3136 participants (Actual)Interventional2008-11-30Terminated(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 3800 participants (Actual)Interventional2020-01-10Completed
Acoustic Assessment of Nebulized Epinephrine Versus Albuterol for RSV Bronchiolitis- a Double Blind Study [NCT00361452]Phase 430 participants Interventional2000-12-31Terminated
Effect of Dexmedetomidine as Adjuvant to Ropivacaine for Brachial Plexus Block [NCT05767827]40 participants (Anticipated)Interventional2023-02-01Recruiting
Effects of Epinephrine and I.V. Needle on CPR Outcome [NCT00121524]Phase 2904 participants (Actual)Interventional2003-01-31Completed
Can the Risk of RD and Hypoglycemia in Children Born at Elective CS be Reduced by Injection of Adrenaline [NCT00322660]270 participants (Actual)Interventional2006-06-30Completed
A Phase 2B, Randomized, Double Blind, Active Comparator, Multicenter, Safety, and Efficacy Trial of ATX-101 in Subjects Undergoing Total Knee Arthroplasty [NCT05260008]Phase 2305 participants (Anticipated)Interventional2022-06-07Recruiting
Parameters in Fractional Laser Assisted Delivery of Topical Anesthetics: Role of Anesthetic and Application Time [NCT03279757]Phase 415 participants (Actual)Interventional2016-10-01Completed
Phase 3 Study of Adrenaline and Milrinone in Patients With Myocardial Dysfunction [NCT00446017]Phase 360 participants Interventional2003-06-30Completed
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)Interventional2007-05-31Completed
Comparison of Epinephrine Associated With Vasopressin vs Epinephrine Alone in the Treatment of Out-of-Hospital Cardiac Arrests [NCT00127907]Phase 42,416 participants Interventional2004-05-31Completed
Effect of Adrenaline Concentration in Tumescence Solution on Intraoperative Hemodynamics of Liposuction Patients: A Randomized Controlled Trial [NCT05822765]Phase 340 participants (Actual)Interventional2023-05-01Completed
Neosaxitoxin (NeoSTX) Alone and in Combination With Bupivacaine as Prolonged Duration Local Anesthetics: A Phase I Investigator-initiated Dose Escalation Study [NCT01786655]Phase 1105 participants (Actual)Interventional2013-05-31Completed
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)Interventional2022-12-31Withdrawn(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)Interventional2020-12-30Active, 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)Interventional2011-05-31Completed
Phase I/II Study Epinephrine Inhalation Aerosol USP, an HFA-MDI Clinical Study-B for Assessment of Pharmacokinetics [NCT01143051]Phase 1/Phase 224 participants (Actual)Interventional2010-01-31Completed
Determining the Role of Periarticular Multimodal Analgesia in Decreasing Perioperative Pain in Tibial Plateau Fractures [NCT05037812]Early Phase 1150 participants (Anticipated)Interventional2019-03-25Active, not recruiting
Post-Caesarean Section Incisional Infiltration With Lidocaine Versus Lidocaine and Epinephrine;Randomized Controlled Trial. [NCT02274974]Phase 4160 participants (Actual)Interventional2014-08-31Completed
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 290 participants (Actual)Interventional2016-10-31Completed
Liposomal Bupivacaine Versus Bupivacaine for Postoperative Analgesia Following Video-assisted Thoracoscopic Surgery. [NCT03036085]Phase 2/Phase 3200 participants (Anticipated)Interventional2017-02-28Not yet recruiting
Endoscopic Ultrasound-guided Radiofrequency Ablation as a Novel Treatment Option Compared With Adrenalectomy in Left-sided Primary Aldosteronism [NCT05368090]40 participants (Anticipated)Interventional2022-06-03Recruiting
A Prospective Randomized Comparison of the Effects of Lidocaine and Levobupivacaine on Block Dynamics After a Subparaneural Popliteal Sciatic Nerve Block [NCT04397484]Phase 440 participants (Anticipated)Interventional2023-09-20Recruiting
Effect of Epinephrine on Systemic Absorption of Mepivacaine Administered for Brachial Plexus Block in Patients With Chronic Renal Insufficiency [NCT01533545]16 participants (Actual)Interventional2012-09-30Terminated(stopped due to Slow recruitment)
Articaine Efficacy and Safety for 3 Years Old Children: A Clinical Randomized Control Trial [NCT05839548]Phase 3200 participants (Anticipated)Interventional2023-06-01Not yet recruiting
Randomized Controlled Trial of Epinephrine and Albuterol in Bronchiolitis [NCT00114478]600 participants Interventional2003-11-30Active, not recruiting
Comparison of Infraclavicular and Supraclavicular Block Approaches in Ultrasound Guided Brachial Plexus Block [NCT04784104]Phase 470 participants (Anticipated)Interventional2021-03-05Not yet recruiting
Prospective Comparison of Epinephrine and Phenylephrine/Ketorolac (Omidria®) Additives With Regards to Intraoperative Pupil Size [NCT02895035]Phase 459 participants (Actual)Interventional2016-09-01Terminated(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 336 participants (Anticipated)Interventional2021-02-22Not yet recruiting
Trigger Finger Corticosteroid Injection With and Without Local Anesthetic; a Randomized, Double Blind Controlled Trial [NCT04023695]Phase 4110 participants (Actual)Interventional2017-10-01Completed
Propofol-dexmedetomidine Versus Propofol-remifentanil Conscious Sedation for Awake Craniotomy During Epilepsy Surgery [NCT02988050]60 participants (Actual)Interventional2013-08-31Completed
Effect of Epinephrine on Immediate Post-polypectomy Pain in Colorectal Lesions Larger Than 20 mm [NCT04065451]Phase 422 participants (Actual)Interventional2020-01-06Completed
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 220 participants Interventional2002-03-31Completed
[NCT00225043]60 participants (Actual)Interventional2005-06-30Completed
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 3727 participants (Actual)Interventional2006-03-31Completed
Analgesic Efficacy of a Combination of Fentanyl and Lidocaine for Maxillary Infiltration in Teeth With Irreversible Pulpitis [NCT01794533]Phase 264 participants (Actual)Interventional2012-10-31Completed
A Randomized Comparison Between Single- and Double-injection Ultrasound-Guided Costoclavicular Block [NCT03595514]90 participants (Anticipated)Interventional2018-07-30Recruiting
Peri-articular Injections Containing a Corticosteroid During Total Knee Arthroplasty [NCT00492973]101 participants (Actual)Interventional2006-03-31Completed
Surgical Treatment of Carpal Tunnel Syndrome: Local Anesthesia With Epinephrine x Intravenous Regional Anesthesia. Randomized Clinical Trial. [NCT02986347]78 participants (Actual)Interventional2017-05-27Completed
Vasopressin vs. Epinephrine During Neonatal Cardiopulmonary Resuscitation - a Cluster Randomized Controlled Phase I Trial [NCT05738148]Phase 120 participants (Anticipated)Interventional2023-11-27Recruiting
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)Interventional2019-12-10Completed
Goal-Directed Intraoperative Fluid Management Using FloTrac© Monitoring in High-Risk Neurosurgical Patients [NCT02701582]66 participants (Actual)Interventional2014-03-31Completed
Decision Support for Intraoperative Low Blood Pressure [NCT02726620]22,435 participants (Actual)Interventional2017-01-05Completed
Does the Choice of Perioperative Inotropes Has Influence on the Morbidity and Mortality of Infants Operated for Complex Heart Defects? [NCT04380181]250 participants (Actual)Observational2020-05-11Completed
Efficacy of Multimodal Perioperative Analgesia Protocol With Periarticular Drug Injection in Total Knee Arthroplasty: A Randomized, Double Blind Study [NCT01042093]160 participants (Actual)Interventional2010-01-31Completed
Comparison of Topical Vasoconstriction in Endoscopic Sinus Surgery: Cocaine Versus Adrenaline [NCT01706952]Phase 445 participants (Actual)Interventional2012-12-31Completed
Does Single Injection Adductor Canal Block Improve Postoperative Analgesia in Patients Receiving Periarticular Local Anesthesia Injections for Total Knee Arthroplasty? [NCT02276495]55 participants (Actual)Interventional2014-09-26Active, not recruiting
The Effect of Intranasal Vasoconstrictor Medications on Hemodynamic Parameters: A Randomized Double-blind, Placebo-controlled Trial. [NCT02285634]68 participants (Actual)Interventional2014-11-30Completed
Perineural Steroids for Saphenous Peripheral Nerve Blocks: An Equivalency Dosing Study. [NCT02462148]Phase 485 participants (Actual)Interventional2015-07-31Completed
The Effects of Systemic Steroids on the Duration of a Psoas Compartment Block. [NCT02464176]Phase 4115 participants (Actual)Interventional2015-06-30Completed
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 247 participants (Actual)Interventional2015-08-31Completed
Ultrasound-guided Fascia Iliaca Compartment Block Versus Periarticular Infiltration for Pain Management After Total Hip Arthroplasty: A Randomized Controlled Trial [NCT02658240]60 participants (Actual)Interventional2016-04-05Completed
Efficacy of Liposomal Bupivacaine Versus Standard Analgesia in Pain Management of Total Joint Arthroplasty [NCT02197273]211 participants (Actual)Interventional2014-07-31Completed
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 1240 participants (Anticipated)Interventional2021-11-04Recruiting
Perioperative Analgesia for Total Hip Arthroplasty: Lumbar Plexus Block Using Shamrock Technique Versus Fascia Iliaca Block [NCT04670497]70 participants (Actual)Interventional2018-07-01Completed
The Effect of Intranasal Irrigation With Adrenaline Solution on Intraoperative Visualization and Bleeding During Functional Endoscopic Sinus Surgery [NCT04551703]Phase 160 participants (Actual)Interventional2016-07-01Completed
Comparison of 2 Application Techniques for LET (Lidocaine 4%; Epinephrine 0.1%; Tetracaine 0.5%) Gel Used Prior to Simple Laceration Repair [NCT04536493]Phase 448 participants (Actual)Interventional2019-06-19Completed
Postoperative Analgesia After Total Hip Arthroplasty. A Comparison of Continuous Epidural Infusion and Wound Infiltration With Intraarticular Bolus Injection. [NCT00289419]Phase 480 participants (Actual)Interventional2005-02-28Completed
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 41,000 participants (Anticipated)Interventional2005-03-31Completed
Safety and Efficacy of Cocktail Periarticular Injection for Pain Management in Simultaneous Bilateral Total Knee Arthroplasty- A Prospective, Randomized Trial [NCT02270437]Phase 455 participants (Actual)Interventional2014-06-30Completed
[NCT00298571]Phase 2/Phase 3100 participants (Anticipated)Interventional2006-02-28Completed
Buffered vs Unbuffered Local Anesthesia Using Lidocaine, Carbocaine, and Articaine in Mandibular Molars Diagnosed With Symptomatic Irreversible Pulpitis [NCT06047366]Phase 460 participants (Anticipated)Interventional2023-12-05Recruiting
The Effect and Safety of Low Dose Nebulized Epinephrine in the Treatment of Croup [NCT01664507]Phase 484 participants (Anticipated)Interventional2016-01-31Recruiting
Efficacy of Intraoperative Injections on Postoperative Pain Control During Total Hip Arthroplasty: A Prospective, Blinded, Randomized Controlled Study [NCT03119038]Phase 40 participants (Actual)Interventional2016-04-30Withdrawn(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 130 participants (Actual)Interventional2019-08-01Completed
Bupivacaine Digital Blocks: How Long is the Pain Relief and Temperature Elevation? [NCT01698593]44 participants (Actual)Interventional2009-07-31Completed
The Effect of Intraoperative Low Dose Adrenaline on Bleeding in Total Hip Arthroplasty - a Randomized Placebo-controlled Trial [NCT01708642]Phase 3106 participants (Actual)Interventional2012-11-30Completed
"Hemodynamic and Electrocardiographic Effects of Hyaluronidase Associated With Local Anaesthetics: a Double-blind Split-mouth Controlled Trial." [NCT01719978]Phase 420 participants (Actual)Interventional2007-10-31Completed
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 219 participants (Actual)Interventional2013-05-31Terminated(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)Interventional2012-05-31Recruiting
A Randomized Single-blinded Trial of Combined Spinal-Epidural Versus Continuous Epidural Analgesia [NCT01750099]202 participants (Anticipated)Interventional2013-02-28Completed
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 438 participants (Anticipated)Interventional2023-12-12Recruiting
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 440 participants (Actual)Interventional2011-08-31Completed
Incident and Extent of Pulse Alteration During Administration of Various Modes of Local Anesthesia in Children During Routine Dental Treatment [NCT02328729]300 participants (Anticipated)Observational2015-01-31Not yet recruiting
Local Infiltration Analgesia After Abdominal Hysterectomy [NCT01782781]Phase 360 participants (Actual)Interventional2012-11-30Completed
Autologous Fat Grafting for Pedal Fat Pad Atrophy [NCT01796808]31 participants (Actual)Interventional2013-03-31Completed
Pilot Study: Epinephrine, Dexamethasone, and Hypertonic Saline in Children With Bronchiolitis, Randomised Clinical Trial of Efficacy and Safety [NCT01834820]Phase 4120 participants (Actual)Interventional2013-01-31Completed
Efficacy of Prophylactic Epinephrine Solution Injection in Prevention of Delayed Post-sphincterotomy Bleeding in Patients With Transient Bleeding During ERCP [NCT04964869]400 participants (Anticipated)Interventional2021-07-15Recruiting
Onset and Duration of Effect of Lidocaine, Bupivacaine, and Lidocaine/Bupivacaine Mixture With Epinephrine. [NCT01243112]Phase 425 participants (Actual)Interventional2010-05-31Completed
Control of Tourniquet Pain With an Axillary Ring of Subcutaneous Local Anesthetic [NCT01829399]Phase 424 participants (Actual)Interventional2013-04-30Completed
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 240 participants (Actual)Interventional2017-04-27Completed
Intramuscular Epinephrine as an Adjunctive Treatment for Severe Pediatric Asthma Exacerbation [NCT01705964]Phase 449 participants (Actual)Interventional2013-06-30Completed
A Comparison of Tumescence in Breast Reduction Surgery [NCT01602692]Phase 440 participants (Actual)Interventional2012-08-31Completed
Reduction of Hip Arthroscopy Post-operative Pain Using Ultrasound-guided Fascia-iliaca Block [NCT02365961]Phase 484 participants (Actual)Interventional2015-04-30Completed
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 448 participants (Actual)Interventional2017-05-22Completed
A Prospective Randomized Trial of Transversus Abdominis Plane (TAP) INtraoperative Block With Bupivacaine/Dexamethasone aGainst Liposomal Bupivacaine (Exparel®): the TINGLE Trial [NCT03723447]Phase 4102 participants (Actual)Interventional2018-10-23Completed
Vapocoolant Spray as a Novel Local Anesthetic for Cutaneous Abscess Incision and Drainage [NCT01673061]Phase 421 participants (Actual)Interventional2012-08-31Terminated(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 4105 participants (Anticipated)Interventional2023-03-15Recruiting
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 40 participants (Actual)Interventional2021-08-31Withdrawn(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 3126 participants (Actual)Interventional2021-09-01Completed
Postoperative Analgesia After Total Knee Arthroplasty. A Comparison of Continuous Epidural Infusion and Wound Infiltration With Continuous Intraarticular Infusion [NCT00421967]Phase 480 participants (Actual)Interventional2007-01-31Terminated(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 384 participants (Actual)Interventional2013-12-31Completed
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)Interventional2023-06-12Recruiting
LIBERATE - LIposomal Bupivacaine vERsus Adjuncts in Total shouldErs: A Randomized Controlled Trial of Injection at the Brachial Plexus [NCT03887650]Phase 490 participants (Actual)Interventional2019-03-11Completed
Loss of Resistance With Nerve Stimulation Versus Loss of Resistance Alone; Effect on Success of Thoracic Epidural Placement. [NCT03087604]Phase 4100 participants (Actual)Interventional2017-03-17Completed
Tranexamic Acid Versus Adrenaline for Controlling Iatrogenic Endobronchial Bleeding: a Double Blind, Randomized Controlled Trial [NCT04771923]130 participants (Actual)Interventional2021-02-22Completed
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)Interventional2015-09-10Completed
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 223 participants (Actual)Interventional2010-08-31Completed
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 4120 participants (Anticipated)Interventional2022-10-30Recruiting
Efficacy of Ultrasound-guided Transversalis Fascia Plane Blocks for Post-cesarean Section Analgesia: a Randomized Double Blinded Control Study [NCT03236324]Phase 2106 participants (Actual)Interventional2017-09-22Completed
LIA in Hip Arthroscopy Patients: An Extra-Capsular Approach [NCT03070054]Early Phase 174 participants (Actual)Interventional2016-06-30Completed
Arterial Pressure and Stress-Dose Steroids in In-hospital Cardiac Arrest: a Mediation Analysis of Prior Randomized Clinical Trial Data. [NCT02785224]191 participants (Anticipated)Observational2023-12-31Not yet recruiting
Efficacy of Nebulised Hypertonic Saline (3%) Among Children With Mild to Moderately Severe Bronchiolitis - A Double Blind Randomized Controlled Trial. [NCT01276821]Phase 4100 participants (Actual)Interventional2011-01-31Completed
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)Interventional2014-09-30Completed
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)Interventional2014-08-31Completed
Perioperative Pain Management for Total Shoulder Arthroplasty: A Pilot Non-Inferiority Trial [NCT05908851]80 participants (Anticipated)Interventional2023-11-01Not yet recruiting
Optimal Timing of Intercostal Nerve Blocks During Video-Assisted Thoracic Surgeries [NCT02980835]Phase 436 participants (Actual)Interventional2016-09-28Completed
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)Interventional2011-11-07Completed
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 4114 participants (Anticipated)Interventional2022-04-27Recruiting
Postoperative Analgesia After Elective Hip Surgery - Effect of Obturator [NCT03064165]Phase 462 participants (Actual)Interventional2017-08-15Completed
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)Interventional2017-02-01Terminated(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 376 participants (Anticipated)Interventional2023-01-31Not yet recruiting
Prospective Evaluation of Topical Anesthesia in Children [NCT04378283]99 participants (Actual)Interventional2016-05-31Completed
Second-look Endoscopy in High Risk Patients After Endoscopic Hemostasis to Their Bleeding Peptic Ulcers Improves Their Outcomes [NCT02352155]157 participants (Actual)Interventional2015-02-04Terminated
Optimal Method for Mydriasis in Cataract Surgery [NCT02909140]3 participants (Actual)Interventional2016-09-30Terminated(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)Interventional2023-06-01Active, not recruiting
A Randomized Double-Blinded, Placebo-Controlled Study of Omalizumab for Idiopathic Anaphylaxis [NCT00890162]Phase 216 participants (Actual)Interventional2009-04-27Completed
Metabolic Adaptation to High-frequent Hypoglycaemia in Type 1 Diabetes - the HypoADAPT Study [NCT05095259]60 participants (Anticipated)Interventional2019-12-16Active, not recruiting
A Clinical Comparison of Microsurgical Versus Conventional Surgical Approaches for the Semilunar Coronally Advanced Flap [NCT02433899]Phase 414 participants (Actual)Interventional2010-10-31Completed
Comparison of Plasma Concentrations of Levobupivacaine With and Without Epinephrine for Transversus Abdominis Plane Block Under Ultrasound. [NCT01596998]Phase 411 participants (Actual)Interventional2011-12-31Completed
Efficacy of Alkalinised 2% Mepivacaine for Local Infiltration Anesthesia, in Ambulatory Phlebectomy [NCT01611324]Phase 4100 participants (Actual)Interventional2012-05-31Completed
Assessment and Hemodynamic Response in CABG After Cardiopulmonary Bypass Using Intraoperative Transesophegeal Echocardiography [NCT01616069]Phase 481 participants (Actual)Interventional2012-02-29Completed
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 31,812 participants (Anticipated)Interventional2014-10-31Suspended(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)Interventional2013-08-31Completed
Cardiac Index Changes With Ephedrine, Phenylephrine, Ondansetron and Norepinephrine During Spinal Anesthesia for Cesarian Section [NCT03421860]Phase 4120 participants (Actual)Interventional2017-02-23Completed
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)Observational2018-04-01Completed
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)Interventional2013-12-31Terminated(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)Interventional2022-01-01Withdrawn(stopped due to Shift in research focus)
Efficacy of Injected Local Anesthetic vs Topical Anesthetic in Cosmetic Injectable Fillers [NCT02379221]49 participants (Actual)Interventional2014-09-30Completed
Fertility and Pregnancy in Patients With Classic Congenital Adrenal Hyperplasia [NCT06153043]55 participants (Anticipated)Observational2023-12-31Not yet recruiting
Optimal Vasopressor Titration Pilot Randomized Controlled Trial [NCT01800877]120 participants (Actual)Interventional2013-04-30Completed
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 2146 participants (Actual)Interventional2021-01-01Completed
Anesthetic Efficacy of 4% Buffered Lidocaine in Emergency Patients With Facial Swelling. [NCT01981772]88 participants (Actual)Interventional2013-03-31Completed
Comparision Between Hemodynamic Response of Dexmedetomidine and Remifentanil for Epinephrine Local Injection in Patient With Endoscopic Sinus Surgery Under General Anesthesia [NCT02464722]Phase 450 participants (Anticipated)Interventional2015-08-31Enrolling 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)Interventional2016-05-31Terminated(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 487 participants (Actual)Interventional2016-07-31Completed
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)Interventional2015-08-07Completed
Liposomal Bupivacaine in Implant Based Breast Reconstruction [NCT02659501]24 participants (Actual)Interventional2015-07-31Terminated
Post-surgical Pain Care Pathways During Enhanced Recovery Surgery Using Exparel (Bupivacaine Liposome Injectable Suspension) Plus Bupivacaine With Epinephrine Versus Bupivacaine. [NCT03001453]Phase 2107 participants (Actual)Interventional2014-04-30Completed
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 420 participants (Actual)Interventional2018-06-14Completed
Efficacy of Subcutaneous Infiltration With Local Anesthetic During Elective Cesarean Delivery for Postoperative Pain Control: a Randomized Controlled Trial [NCT03383588]Phase 226 participants (Actual)Interventional2018-07-19Terminated(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 4160 participants (Actual)Interventional2017-07-19Completed
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)Observational2017-02-01Completed
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)Interventional2019-12-01Recruiting
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 298 participants (Actual)Interventional2007-06-30Completed
Inhaled Beta-2 Agonist Versus Epinephrine For Treatment of Transient Tachypnea of Newborn [NCT05006235]Phase 1135 participants (Actual)Interventional2014-02-01Completed
The Effect of Popliteal Plexus Block on Postoperative Pain After Total Knee Arthroplasty [NCT03198403]Phase 417 participants (Actual)Interventional2017-08-01Completed
Efficacy of External Nasal Nerve Block on Postoperative Agitation Following Nasal Surgeries Under General Anesthesia. Randomized, Controlled Trial [NCT03069027]100 participants (Actual)Interventional2016-08-15Completed
To Compare the Pulpal Oxygen Saturation Level After Administering Mepivacaine With and Without Vasoconstrictor: A Randomized Clinical Trial [NCT04947267]Phase 260 participants (Actual)Interventional2018-05-30Completed
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 480 participants (Anticipated)Interventional2017-05-22Recruiting
The Pectoral Block for Breast Augmentation Surgery: a Volunteers' and Patients' Study. [NCT03040167]Phase 420 participants (Actual)Interventional2017-10-01Completed
Early Ultrasound-guided Nerve Block for Painful Hand Injuries in the Emergency Department [NCT03195413]15 participants (Actual)Interventional2017-07-01Completed
Ultrasound-guided Median Nerve Block With Dextrose 5% Hydrodissection: Determination of the Minimal Effective Volume of Local Anesthetic [NCT02438657]Phase 2/Phase 352 participants (Actual)Interventional2015-05-21Completed
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)Interventional2015-04-30Completed
Two-arm, Double-blind Randomized Study Comparing Exparel and Exparel Plus an Adductor Canal Block in Total Knee Arthroplasty [NCT02365727]Phase 40 participants (Actual)Interventional2015-04-30Withdrawn(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 4200 participants (Actual)Interventional2014-04-30Completed
Psoas Compartment Block Versus Periarticular Local Anesthetic Infiltration for Pain Management for Total Hip Arthroplasty: A Prospective, Randomized Study [NCT02658149]Phase 4100 participants (Actual)Interventional2016-05-31Completed
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 434 participants (Anticipated)Interventional2019-04-10Recruiting
Comparison of Two Different Concentrations of Local Anesthetic in Patient Reported Pain in Oculoplastic Surgery [NCT06121141]Phase 430 participants (Anticipated)Interventional2023-08-07Enrolling by invitation
Clinical Effectiveness of Erector Spinae Plane Block in Peri-operative Analgesia for Laparoscopic Kidney Procedures [NCT03874091]62 participants (Actual)Interventional2019-01-15Completed
A Phase 2, Two-Part, Multicenter Study of HTX-011 in Spinal Surgery [NCT04911062]Phase 232 participants (Actual)Interventional2022-04-07Completed
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)Interventional2016-10-21Recruiting
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 290 participants (Anticipated)Interventional2017-04-30Recruiting
Role of Adrenaline in the Inflammatory Response in People With Diabetes Mellitus Type 1, and Healthy Individuals [NCT05990933]30 participants (Anticipated)Interventional2023-09-30Not 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)Interventional2022-09-01Completed
Local Injection of Tranexamic Acid May Reduce Bleeding, Injection Pain, and Other Post-op Complications During Mohs Micrographic Surgery [NCT04630886]Early Phase 1200 participants (Anticipated)Interventional2021-06-16Enrolling by invitation
Adjuvants to Ultrasonic Guided Interscalene Block In Arthroscopic Rotator Cuff Repair; Morphine and/or Nalbuphine [NCT03034382]Phase 280 participants (Anticipated)Interventional2016-01-31Recruiting
CanROC Epinephrine Dose: Optimal Versus Standard Evaluation Trial (CanROC EpiDOSE Trial) [NCT03826524]Phase 43,790 participants (Anticipated)Interventional2023-05-24Recruiting
Evaluation of Cardiac Arrhythmias in Hand Surgery Using Local Anesthesia With Adrenaline [NCT04029610]110 participants (Actual)Interventional2018-08-14Completed
Gonyautoxins Local Periarticular Injection for Pain Management After Total Knee Arthroplasty: A Double Blind Randomized Study [NCT03025594]Phase 364 participants (Anticipated)Interventional2017-01-31Recruiting
Nebulized Epinephrine Versus Nebulized Salbutamol in Bronchiolitis Among Children Aged 1month-24months [NCT03814954]90 participants (Actual)Interventional2019-01-01Completed
Ultrasound-guided Peripheral Nerve Block for Non-intubated Uniportal Video-assisted Thoracoscopic Surgery [NCT03083080]30 participants (Anticipated)Interventional2017-03-27Not yet recruiting
Pharmacokinetics of Intramuscular Adrenaline in Food--Allergic Teenagers: Does Dose Matter? [NCT03366298]Phase 412 participants (Actual)Interventional2017-11-24Completed
Characterizing and Comparing the Duration of Local Anesthetic in Dermatologic Surgery [NCT05767749]Phase 475 participants (Actual)Interventional2023-03-14Completed
Does the Addition of Epinephrine Increase the Duration of Intrathecal Hyperbaric Bupivacaine for Repeat Cesarean Section? [NCT02369510]Phase 468 participants (Actual)Interventional2015-02-28Completed
Comparison of Rectal Infiltration of Exparel vs. 0.25% Bupivacaine With Epinephrine vs. Placebo for Analgesic Benefit Following Hemorrhoidectomy [NCT02104414]Phase 411 participants (Actual)Interventional2014-04-30Terminated(stopped due to low enrollment)
Preemptive Local Anesthesia in Vaginal Surgery, A Prospective, Randomised Trial [NCT00318292]Phase 490 participants (Actual)Interventional2006-04-30Completed
Phase 3 Study of Ropivacaine (With Epinephrine) in BABA Endoscopic and Robotic Thyroidectomy [NCT02112370]Phase 3148 participants (Actual)Interventional2014-05-31Completed
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 2100 participants (Actual)Interventional2007-09-30Completed
Methemoglobin Levels in Generally Anesthetized Pediatric Dental Patients Receiving Prilocaine Versus Lidocaine [NCT01402869]91 participants (Actual)Interventional2011-08-31Completed
Subcutaneous Tranexamic Acid in Nasal Mohs Local Flap Reconstruction: Perioperative Bleeding, Edema, and Ecchymosis [NCT06057675]Phase 2100 participants (Anticipated)Interventional2023-12-31Not 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)Interventional2019-03-20Completed
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 440 participants (Anticipated)Interventional2020-12-01Not 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 31,482 participants (Actual)Interventional2013-01-31Completed
Administration of Local Anesthetic in Trigger Thumb Surgery: A Randomized Clinical Trial [NCT03873480]31 participants (Actual)Interventional2018-10-02Completed
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)Interventional2021-03-01Recruiting
Fast-track Rehabilitation Protocol for Total Knee Arthroplasty: A Randomized Controlled Trial Comparing Local Infiltration Analgesia With Femoral Nerve Block [NCT01966263]Phase 480 participants (Actual)Interventional2013-11-30Completed
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)Interventional2017-02-28Recruiting
Alkalinization of Adrenalized Lidocaine in Extending Epidural Analgesia for Extremely Urgent Cesarean Section During Labor: a Randomized Controlled Trial. [NCT05313256]Phase 2/Phase 366 participants (Anticipated)Interventional2022-07-14Recruiting
The Use of Epinephrine Infusion for Prophylaxis Against Maternal Hypotension During Cesarean Delivery: a Randomized Controlled Dose-finding Trial [NCT05279703]Phase 4276 participants (Anticipated)Interventional2022-03-21Recruiting
Voiding Function After Mid-Urethral Slings With and Without Local Anesthetic: Randomized Controlled Trial [NCT01583166]90 participants (Actual)Interventional2012-03-31Completed
Comparison of Different Approaches for Supraclavicular Block and Their Effects on Diaphragm Muscle Function Evaluated With Diaphragm Thickening Fraction [NCT04756050]Phase 490 participants (Actual)Interventional2021-02-16Completed
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 434 participants (Actual)Interventional2019-12-01Completed
Treatment of Ventricular Tachyarrhythmias Refractory To Shock With Beta Blockers: The SHOCK and BLOCK Trial [NCT00401882]Phase 27 participants (Actual)Interventional2007-01-31Terminated(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)Interventional2010-09-30Completed
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 3204 participants (Actual)Interventional2008-08-31Completed
Risk Factors and Postoperative Complications of Reperfusion Syndrome and Vasoplegic Syndrome in Patients With Vasoactive Support During Liver Transplant Surgery [NCT05658120]246 participants (Actual)Observational2022-12-13Completed
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 494 participants (Actual)Interventional2017-12-05Completed
Comparison of Pain of Conventional to Buffered Local Anesthesia During Injection in Pediatric Dental Patients. A Prospective, Double-blind, Randomized, Crossover Study [NCT01622296]Phase 420 participants (Actual)Interventional2012-04-30Completed
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 480 participants (Actual)Interventional2013-04-30Completed
Epinephrine in the Pediatric Intensive Care Unit: A Dose-Effect Trial (EPI Dose) [NCT05327556]Phase 286 participants (Anticipated)Interventional2023-02-08Enrolling 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 328 participants (Anticipated)Interventional2023-06-01Not yet recruiting
Efficacy of Buprenorphine on Postoperative Endodontic Analgesia [NCT03268278]Phase 110 participants (Actual)Interventional2017-04-01Terminated(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)Interventional2023-11-01Not 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)Interventional2023-01-01Recruiting
Evaluation of New Methods for Prediction of Fetal Lung Maturity in Diabetic Mothers [NCT03159234]54 participants (Actual)Interventional2016-04-30Completed
CLINICAL STUDY-B3 FOR ASSESSMENT OF PHARMACOKINETICS, A Randomized, Evaluator-Blind, Single-Dose, Three Arm, Crossover,PK Study in Healthy Volunteers [NCT01255709]Phase 224 participants (Actual)Interventional2010-12-31Completed
Comparison Between Epinephrine Versus Tranexamic Acid Usage During Upper Gastrointestinal Tract Endoscopic Resection Procedures for the Reduction of Intraprocedural and Postprocedural Bleeding [NCT05688020]Phase 4200 participants (Anticipated)Interventional2023-02-01Recruiting
Articaine Success in Pulpectomy of Primary Molars With Irreversible Pulpitis in Children Under Four Years: a Randomized Controlled Trial [NCT05944341]164 participants (Anticipated)Interventional2023-06-01Recruiting
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 31,025 participants (Actual)Interventional2015-07-20Completed
Hypoglycemia Associated Autonomic Dysfunction Dose Response of Epinephrine [NCT02692313]Early Phase 132 participants (Anticipated)Interventional2016-06-30Recruiting
Articaine 4% Efficacy and Safety in Extraction and Pulpotomy of Primary Molars of Children Below the Age of Four Years. [NCT05101785]292 participants (Anticipated)Interventional2021-11-01Not 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)Interventional2014-10-31Completed
Complication in Laparoscopic Renal and Adrenal Surgery (CLARAS): an International Multicenter Study [NCT05322265]350 participants (Anticipated)Observational2017-04-01Recruiting
The Effect of the Popliteal Plexus Block on Postoperative Pain After Total Knee Arthroplasty - a Randomized, Controlled, Double-blinded Study [NCT03439787]Phase 415 participants (Actual)Interventional2018-05-15Terminated(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 366 participants (Actual)Interventional2017-10-01Completed
Nor-epinephrine Versus Midodrine/Octreotide in Patients With Hepatorenal Acute Kidney Injury [NCT04522297]91 participants (Actual)Interventional2018-04-15Completed
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)Interventional2021-03-10Completed
Intravenous Epinephrine Bolus for Prevention of Postintubation Collapse in Intensive Care Septic Patients Predicted by Shock Index. [NCT06115473]44 participants (Anticipated)Interventional2023-08-01Recruiting
Impact of Adding iPACK Block With Dexamethasone to Existing APS Multimodal Analgesia Protocol for Patients Undergoing Total Knee Arthroplasty [NCT04917055]Phase 414 participants (Actual)Interventional2021-06-07Terminated(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 275 participants (Actual)Interventional2020-12-04Active, 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)Interventional2019-09-05Recruiting
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)Interventional2022-03-31Not 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 464 participants (Actual)Interventional2015-10-31Terminated(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 30 participants (Actual)Interventional2018-06-01Withdrawn(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 4834 participants (Anticipated)Interventional2018-01-01Recruiting
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 40 participants (Actual)Interventional2019-10-31Withdrawn(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 4150 participants (Anticipated)Interventional2019-11-25Recruiting
Adrenal Artery Ablation Treats Primary Aldosteronism With Resistant Hypertension (AAA-RHT) [NCT04345198]36 participants (Actual)Interventional2017-10-01Completed
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)Interventional2015-04-30Withdrawn
A Prospective, Randomized Clinical Trial of Two Periarticular Multimodal Drug Injections in Total Hip and Knee Arthroplasty [NCT02543801]Phase 4239 participants (Actual)Interventional2016-01-25Completed
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 4165 participants (Actual)Interventional2014-09-30Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
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

Interventionpoints on a scale (Mean)
Preemptive Local Analgesia (PLA)2.5
Placebo4.4

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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

InterventionParticipants (Number)
Adrenaline106
Vasopressin119

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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

,
InterventionParticipants (Number)
Cerebral Performance Categories 1Cerebral Performance Categories 2Overall Performance Categories 1Overall Performance Categories 2
Adrenaline5023
Vasopressin4150

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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

,
InterventionParticipants (Number)
Cerebral Performance Categories 1Cerebral Performance Categories 2Overall Performance Categories 1Overall Performance Categories 2
Adrenaline5032
Vasopressin4131

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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

InterventionParticipants (Number)
Adrenaline8
Vasopressin11

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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

InterventionParticipants (Number)
Adrenaline59
Vasopressin83

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Adverse Effects

(NCT00401882)
Timeframe: 30 days

InterventionParticipants (Count of Participants)
Additional Doses of Epinephrine0
Metoprolol Instead of Additional Epinephrine Doses0

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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

InterventionParticipants (Count of Participants)
Additional Doses of Epinephrine0
Metoprolol Instead of Additional Epinephrine Doses1

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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

InterventionParticipants (Count of Participants)
Additional Epinephrine Doses0
Metoprolol Instead of Additional Epinephrine Doses0

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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)

,
InterventionZ score (Mean)
BaselinePost BronchodilatorPost Epinephrine
Healthy Control0.0710.1860.041
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

Interventionpg/dl (Mean)
Healthy Control183.526
Bronchiolitis and Respiratory Syncytial Virus-Nasal Wash Only568.867

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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

InterventionUnits on a scale*hours (Mean)
Bupivacaine HCl 105mg298.1
SKY0402 Low Dose286.9
SKY0402 Middle Dose274.6
SKY0402 High Dose274.4

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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

InterventionUnits on a scale*hours (Mean)
Bupivacaine HCl20.4
SKY0402 Low Dose20.7
SKY0402 Low-mid Dose19.5
SKY0402 High-mid Dose18.8
SKY0402 High Dose19.1

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Length of Hospital Stay

(NCT00492973)
Timeframe: days after surgery

Interventiondays (Mean)
Control Group3.5
Corticosteroid2.6

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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

Interventionunits on a scale (Mean)
Control Group87.1
Corticosteroid83.3

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Knee Range of Motion

(NCT00492973)
Timeframe: 3 months

Interventiondegrees (Mean)
Control Group112.5
Corticosteroid112.4

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Complications, Such as Infections, Hospital Readmissions, Manipulations Under Anesthesia, Etc.

(NCT00492973)
Timeframe: any point during the first postoperative year

InterventionNumber of participants with complication (Number)
Control Group0
Corticosteroid3

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Amount of Pain Medication Taken Per Day

(NCT00492973)
Timeframe: Average of 3 days after surgery

Interventionmg/day morphine equivalant (Mean)
Control Group47.8
Corticosteroid46.0

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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

Interventionunits on a scale*hrs (Mean)
SKY0402 300mg175
SKY0402 225mg172
SKY0402 75mg225
Bupivacaine HCl331

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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

Interventiondays (Mean)
LIA IV (Local Infiltration Analgesia, Intravenous)4
LIA IA, (Local Infiltration Analgesia, Intra-articular)3.5
Epidural5.5

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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

InterventionUnits on a scale (Mean)
LIA IV (Local Infiltration Analgesia, Intravenous)18
LIA IA, (Local Infiltration Analgesia, Intra-articular)12
Epidural30

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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

Interventionmg (Mean)
LIA IV (Local Infiltration Analgesia, Intravenous)77
LIA IA, (Local Infiltration Analgesia, Intra-articular)49
Epidural54

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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

InterventionUnits on a scale*hours (Mean)
Bupivacaine HCl359
SKY0402396

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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

InterventionUnits on a scale*hours (Mean)
SKY0402441
Bupivacaine HCl467

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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

Interventionpercentage of change of events (Mean)
Omalizumab32
Placebo6

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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

InterventionParticipants (Number)
Conventional Ibuprofen32
Brufen Retard29

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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

Interventionunits on a scale (Mean)
Periarticular Injection Group2.3
No Injection Group6.4

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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

Interventiondegree (Mean)
Periarticular Injection Group92.3
No Injection Group95.2

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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

Interventionmicrogram (Mean)
Periarticular Injection Group169.4
No Injection Group262.3

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the Proportion of Patients Who Were Satisfied With the Pain Management

(NCT00901628)
Timeframe: postoperative 7 day

Interventionparticipants (Number)
Periarticular Injection Group38
No Injection Group39

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The Proportion of Patients Who Could Raise Leg With Replaced Knee Extended

(NCT00901628)
Timeframe: 24 hours postoperative

Interventionparticipants (Number)
Periarticular Injection Group18
No Injection Group6

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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

Interventionparticipants (Number)
Periarticular Injection Group22
No Injection Group15

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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

,,,
Interventionmg (Mean)
Morphine Equivalent Day of SurgeryMorphine Equivalent Post Operative Day 1Morphine Equivalent Post Operative Day 2Morphine Equivalent Post Operative Day 3
ROP/EPI52.5051.0836.7615.54
ROP/EPI/CLO55.2064.6150.0721.97
ROP/EPI/TOR43.0947.9542.6918.72
ROP/EPI/TOR/CLO46.9246.5440.7120.45

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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

,,,
Interventionscores on a scale 0-10 (Mean)
Vas Pain Scale - 1 Hour Post OpVas Pain Scale - 8 Hour Post OpVas Pain Scale - 16 Hour Post OpVas Pain Scale - 24 Hour Post OpVas Pain Scale - 32 Hour Post OpVas Pain Scale - 40 Hour Post OpVas Pain Scale - 48 Hour Post OpVas Pain Scale Preoperatively
ROP/EPI1.602.822.412.963.132.802.112.13
ROP/EPI/CLO2.673.932.753.633.623.282.562.43
ROP/EPI/TOR1.901.522.222.562.662.351.972.47
ROP/EPI/TOR/CLO1.061.521.852.332.182.542.411.93

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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

InterventionScores on a scale 0-50 (Mean)
ROP/EPI/TOR/CLO45
REP/EPI/TOR43
REP/EPI/CLO45
REP/EPI45

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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

Interventionpercentage of participants (Number)
Phenylephrine45
Epinephrine39
Control87

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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

,,
InterventionmmHg (Mean)
Pre-dose (Baseline)10 min post-dose30 min post-dose60 min post-dose120 min post-dose180 min post-dose360 min post-dose
Treatment C111121116115114115113
Treatment T1110123116113112114113
Treatment T2112122117113114113113

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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

,,
Interventionbeats per minute (Mean)
Pre-dose (Baseline)10 min post-dose30 min post-dose60 min post-dose120 min post-dose180 min post-dose360 min post-dose
Treatment C58626161586361
Treatment T160676367606664
Treatment T262696467606664

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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

,,
Interventionpg/mL (Mean)
Total Epinephrine, 0 min (Baseline)Total Epinephrine, 5 min post-doseTotal Epinephrine, 15 min post-doseTotal Epinephrine, 30 min post-doseTotal Epinephrine, 45 min post-doseTotal Epinephrine, 60 min post-doseTotal Epinephrine, 90 min post-doseTotal Epinephrine, 120 min post-doseTotal Epinephrine, 180 min post-doseTotal Epinephrine, 240 min post-doseTotal Epinephrine, 360 min post-dose
Treatment C7.8130.238.516.820.918.016.713.18.49.838.3
Treatment T19.3339.648.912.78.67.65.78.712.012.931.1
Treatment T28.9442.462.417.413.014.513.715.510.411.529.4

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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

Interventionmin (Mean)
Treatment T134.6
Treatment T237.0
Treatment C38.0

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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

Interventionpg/mL (Mean)
Treatment T1340
Treatment T2444
Treatment C139

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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

InterventionParticipants (Count of Participants)
Randomized Subjects0

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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

,,
Interventionmmol/L (Mean)
Pre-dose (Baseline)15 min post-dose30 min post-dose60 min post-dose120 min post-dose360 min post-dose
Treatment C444444
Treatment T1444444
Treatment T2444444

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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

,,
InterventionmmHg (Mean)
Pre-dose (Baseline)10 min post-dose30 min post-dose60 min post-dose120 min post-dose180 min post-dose360 min post-dose
Treatment C61656563625962
Treatment T162636463616262
Treatment T261646464636062

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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

,,
Interventionscore on a scale (Mean)
Pre-dose (Baseline)10 min post-dose60 min post-dose360 min post-dose
Treatment C0.00.10.00.0
Treatment T10.00.10.00.0
Treatment T20.00.20.00.0

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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

,,
Interventionmg/dL (Mean)
Pre-dose (Baseline)15 min post-dose30 min post-dose60 min post-dose120 min post-dose360 min post-dose
Treatment C849698948380
Treatment T18310194868182
Treatment T28310599868282

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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

Interventionpg*min/mL (Mean)
Treatment T17938
Treatment T29438
Treatment C7218

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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

Interventionpg/mL (Mean)
Treatment T19.3
Treatment T28.9
Treatment C7.8

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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

Interventionmin (Mean)
Treatment T1125.9
Treatment T2158.8
Treatment C237.3

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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

,,
Interventionmsec (Mean)
Pre-dose (Baseline)30 min post-dose90 min post-dose360 min post-dose
Treatment C423413407400
Treatment T1416404399399
Treatment T2407405401400

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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

,,
Interventionmsec (Mean)
Pre-dose (Baseline)30 min post-dose90 min post-dose360 min post-dose
Treatment C403412403402
Treatment T1407408401403
Treatment T2407411401403

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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

InterventionParticipants (Count of Participants)
Randomized Subjects0

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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

Interventionpg/mL (Mean)
Treatment T2.6
Treatment C4.3

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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

Interventionmin (Mean)
Treatment T145.9
Treatment C289.8

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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

Interventionpg/mL (Mean)
Treatment T862
Treatment C190

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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

Interventionmin (Mean)
Treatment T2.3
Treatment C3.4

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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

Interventionpg*min/mL (Mean)
Treatment T8498
Treatment C6191

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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

,
Interventionpg/mL (Mean)
0 min (Baseline)2 min post-dose5 min post-dose7.5 min post-dose10 min post-dose12.5 min post-dose15 min post-dose20 min post-dose25 min post-dose30 min post-dose45 min post-dose60 min post-dose90 min post-dose120 min post-dose240 min post-dose360 min post-dose
Treatment C4.3189.099.148.839.733.932.030.120.317.719.813.211.26.917.717.2
Treatment T2.6861.5379.4186.6118.375.646.822.910.910.510.58.73.56.516.117.1

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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

Interventionminutes (Mean)
1% Lidocaine With Epinephrine0.25% Bupivacaine With Epinephrine0.5% Lidocaine and 0.125% Bupivacaine With Epineph1% Lidocaine and 0.25% Bupivacaine With Epinephrin
Study Group6.637.027.487.16

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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

Interventionsecond (Mean)
1% Lidocaine With Epinephrine0.25% Bupivacaine With Epinephrine0.5% Lidocaine and 0.125% Bupivacaine With Epineph1% Lidocaine and 0.25% Bupivacaine With Epinephrin
Study Group29192612

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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

Interventionunits on a scale (Mean)
Standard2.26
Study3.57

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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

,
InterventionParticipants (Number)
Hospital Re-visit within 24 hoursNo Hospital Re-visit within 24 hours
Standard1535
Study545

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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

,
Interventionparticipants (Number)
Persistence of cough at the end of 1 weekAbsence of cough at the end of 1 week
Standard3713
Study3119

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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

,
Interventionparticipants (Number)
Unscheduled medical Visits in 1 weekNo Unscheduled medical visits in 1 week
Standard2327
Study1832

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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

Interventionparticipants (Number)
Standard10
Study3

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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

InterventionMinutes (Mean)
Standard2.16
Study2.03

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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

,
Interventionparticipants (Number)
Meets Criteria for ER/OPD discharge after 120 minsDoes not meet criteria for ER/OPD discharge
Standard1535
Study3515

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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.

Interventionmg iv morphin equivalent (Mean)
Bilateral Ultrasoundguide TAP-catheter35

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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

InterventionUnits on Numerical Rating Score (Median)
NRS at rest, all timesOverall NRS when coughing, all times
Bilateral Ultrasoundguide TAP-catheter35

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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

Interventionminutes (Mean)
Prilocaine62.73
Lidocaine57.50
No Local Anesthetic29.50

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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

Interventionpercentage of methemoglobin in blood (Mean)
Prilocaine3.55
Lidocaine1.63
No Local Anesthetic1.60

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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

Interventionpercentage of methemoglobin in blood (Mean)
Prilocaine2.73
Lidocaine0.78
No Local Anesthetic0.76

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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

InterventionMinutes (Median)
TAP Block47.4
No Block34.5

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Narcotic Use

narcotic use in mg of Morphine will be recorded (NCT01479270)
Timeframe: Postop Day #0 and Day #1

,
Interventionmg of morphine (Median)
Post operative day #0Post operative day #1
No Block11.89.0
Tap Block11.77.5

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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

,
Interventionunits on a scale (Median)
2 hours post operative24 hours post operative
No Block6.05.0
Tap Block5.05.0

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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

Interventionunits on a scale (Median)
TAP Block168.0
No Block169.5

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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

InterventionParticipants (Count of Participants)
Marcaine + Epinephrine31
Saline + Epinephrine32

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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

Interventionunits on a scale (Mean)
Marcaine + Epinephrine3.1
Saline + Epinephrine4.1

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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

Interventionunits on a scale (Mean)
Marcaine + Epinephrine3
Saline + Epinephrine2.9

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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

InterventionReported Pain Level score on VAS (Mean)
Marcaine + Epinephrine0.0
Saline + Epinephrine0.0

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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

,
Interventionmg (Mean)
Mean Intraoperative hydromorphoneMean Intraoperative midazolamMean Intraoperative ketorolacMean Intraoperative dexamethasoneMean Intraoperative ondansetron
Tumescent Solution With Dilute Epinephrine0.982.0011.256.403.60
Tumescent Solution With Dilute Lidocaine and Epinephrine1.061.9016.506.004.05

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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

,
Interventionmg (Mean)
PACU IV hydromorphoneFirst 24 hr Post-op oxycodone
Tumescent Solution With Dilute Epinephrine0.8932.19
Tumescent Solution With Dilute Lidocaine and Epinephrine0.5529.47

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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

InterventionParticipants (Count of Participants)
Tumescent Solution With Dilute Epinephrine0
Tumescent Solution With Dilute Lidocaine and Epinephrine0

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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

Interventionminutes (Mean)
Tumescent Solution With Dilute Epinephrine158
Tumescent Solution With Dilute Lidocaine and Epinephrine153

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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

Interventionmicrograms (Mean)
Tumescent Solution With Dilute Epinephrine131.30
Tumescent Solution With Dilute Lidocaine and Epinephrine120.00

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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

,
Interventionscore on a scale (Mean)
End of PACU Mean Pain LevelFirst 24 hrs Post-op Mean Current PainFirst 24 hrs Post-op Mean Worst PainFirst 24 hrs Post-op Mean Least Pain
Tumescent Solution With Dilute Epinephrine5.474.006.442.00
Tumescent Solution With Dilute Lidocaine and Epinephrine4.474.286.682.53

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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

,
Interventionepisodes (Number)
NauseaVomiting
Tumescent Solution With Dilute Epinephrine82
Tumescent Solution With Dilute Lidocaine and Epinephrine104

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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

,
Interventionunits on a scale (Mean)
Pain on inferior alveolar nerve blockPain on long buccal nerve block
Buffered Lidocaine33.19.8
Lidocaine437.3

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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

InterventionParticipants (Number)
MK-823773
Placebo19

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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)

InterventionScore on a Scale (Mean)
MK-82376.40
Placebo7.62

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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)

InterventionScore on a Scale (Mean)
MK-82374.67
Placebo5.49

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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)

InterventionScore on a Scale (Mean)
MK-82373.83
Placebo4.46

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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)

InterventionScore on a Scale (Mean)
MK-82370.84
Placebo1.03

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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)

InterventionScore on a Scale (Mean)
MK-823742.29
Placebo47.96

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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

InterventionParticipants (Number)
MK-8237676
Placebo539

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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)

InterventionParticipants (Count of Participants)
IM Epinephrine 1:100015
No Intervention12

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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

Interventionpercentage of PEFR (Mean)
IM Epinephrine 1:100064.51
No Intervention56.18

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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

Interventionpercentage of predicted (Mean)
IM Epinephrine 1:100059.56
No Intervention52.45

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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

Interventionbreaths per minute (Mean)
IM Epinephrine 1:100024.29
No Intervention29.29

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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

InterventionBeats per minute (Mean)
IM Epinephrine 1:1000147.65
No Intervention142.29

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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

InterventionHeart Beats per minute (Mean)
Cocaine SIDE74.68
Adrenaline SIDE73.62

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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

InterventionmmHg (Mean)
Cocaine SIDE68.02
Adrenaline SIDE68.41

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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

InterventionPercentage of carbon dioxide (Mean)
Cocaine SIDE32.26
Adrenaline SIDE31.69

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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

Interventionunits on a scale (Mean)
Cocaine SIDE2.17
Adrenaline SIDE2.04

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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

Interventionhours (Median)
Femoral Nerve Block3.3
Standard Anesthetic Management3.8

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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

Interventionpain score (Median)
Femoral Nerve Block0
Standard Anesthetic Management3

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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.

Interventionpercentage of isoflurane (Median)
Femoral Nerve Block1.1
Standard Anesthetic Management1.5

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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

InterventionmmHg (Mean)
Liberal Approach79
Restrictive Approach70

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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.

InterventionMinutes (Mean)
Bupivacaine Axillary Ring on 1st Visit30.5
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.

Interventionscores on a scale (Mean)
Bupivacaine Ring 1st Visit6.1
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.

InterventionParticipants (Count of Participants)
Articaine52
Buffered Articaine57

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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

Interventionmeters (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

Interventionseconds (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

Interventionseconds (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

Interventionunits on a scale (Mean)
Buffered Lidocaine69.3
Nonbuffered Lidocaine59.2

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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

Interventionunits on a scale (Mean)
Buffered Lidocaine92.7
Nonbuffered Lidocaine89.5

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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

,,,,,,,
Interventionunits on a scale (Mean)
ThrobbingShootingStabbingSharpCrampingGnawingHot-BurningAchingHeavyTenderSplittingTiring-ExhaustingSickeningFearfulPunishing-CruelPresent pain
Paradigm 1 / Deoxycholic Acid Injection0.00.00.00.00.00.00.00.00.00.00.00.00.00.00.00.0
Paradigm 1 / Placebo0.00.00.00.00.00.00.00.00.00.00.00.00.00.00.00.0
Paradigm 2 / Deoxycholic Acid Injection0.00.00.00.00.00.00.00.00.00.10.00.00.00.00.00.0
Paradigm 2 / Placebo0.00.00.00.00.00.00.00.00.00.00.00.00.00.00.00.0
Paradigm 3 / Deoxycholic Acid Injection0.00.00.00.00.00.00.00.10.10.10.00.00.00.00.00.0
Paradigm 3 / Placebo0.00.00.00.00.00.00.00.00.00.00.00.00.00.00.00.0
Paradigm 4 / Deoxycholic Acid Injection0.00.00.00.00.00.00.00.00.00.00.00.00.00.00.00.0
Paradigm 4 / Placebo0.00.00.00.00.00.00.00.00.00.00.00.00.00.00.00.0

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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

Interventionunits on a scale (Mean)
Paradigm 1 / Deoxycholic Acid Injection0.2
Paradigm 1 / Placebo0.0
Paradigm 2 / Deoxycholic Acid Injection0.1
Paradigm 2 / Placebo0.5
Paradigm 3 / Deoxycholic Acid Injection0.3
Paradigm 3 / Placebo0.5
Paradigm 4 / Deoxycholic Acid Injection0.3
Paradigm 4 / Placebo0.3

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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

Interventionunits on a scale (Mean)
Paradigm 1 / Deoxycholic Acid Injection0.0
Paradigm 1 / Placebo0.0
Paradigm 2 / Deoxycholic Acid Injection0.0
Paradigm 2 / Placebo0.0
Paradigm 3 / Deoxycholic Acid Injection0.0
Paradigm 3 / Placebo0.0
Paradigm 4 / Deoxycholic Acid Injection0.0
Paradigm 4 / Placebo0.0

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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

Interventionunits 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 / Placebo0.0
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

Interventionunits on a scale (Median)
Paradigm 1 / Deoxycholic Acid Injection0.0
Paradigm 1 / Placebo0.0
Paradigm 2 / Deoxycholic Acid Injection0.0
Paradigm 2 / Placebo0.0
Paradigm 3 / Deoxycholic Acid Injection0.0
Paradigm 3 / Placebo0.0
Paradigm 4 / Deoxycholic Acid Injection0.0
Paradigm 4 / Placebo0.0

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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

Interventionunits 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

Interventionunits on a scale (Mean)
Paradigm 1 / Deoxycholic Acid Injection2.8
Paradigm 1 / Placebo2.3
Paradigm 2 / Deoxycholic Acid Injection3.2
Paradigm 2 / Placebo1.8
Paradigm 3 / Deoxycholic Acid Injection2.3
Paradigm 3 / Placebo2.3
Paradigm 4 / Deoxycholic Acid Injection2.4
Paradigm 4 / Placebo2.0

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Change From Baseline in Submental Fat Thickness

Submental thickness was measured using caliper devices. (NCT02007434)
Timeframe: Baseline and Day 84

Interventionmm (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

Interventionunits on a scale (Mean)
Paradigm 1 / Deoxycholic Acid Injection0.0
Paradigm 1 / Placebo0.0
Paradigm 2 / Deoxycholic Acid Injection0.1
Paradigm 2 / Placebo0.0
Paradigm 3 / Deoxycholic Acid Injection0.0
Paradigm 3 / Placebo0.0
Paradigm 4 / Deoxycholic Acid Injection0.1
Paradigm 4 / Placebo0.0

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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

Interventionunits on a scale (Mean)
Paradigm 1 / Deoxycholic Acid Injection0.0
Paradigm 1 / Placebo0.0
Paradigm 2 / Deoxycholic Acid Injection0.0
Paradigm 2 / Placebo0.0
Paradigm 3 / Deoxycholic Acid Injection0.0
Paradigm 3 / Placebo0.0
Paradigm 4 / Deoxycholic Acid Injection0.0
Paradigm 4 / Placebo0.0

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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

,,,,,,,
Interventionpercentage of participants (Number)
Recommend to a FriendReceive Additional TreatmentsNormal Activity Affected
Paradigm 1 / Deoxycholic Acid Injection818113
Paradigm 1 / Placebo33670
Paradigm 2 / Deoxycholic Acid Injection818813
Paradigm 2 / Placebo50500
Paradigm 3 / Deoxycholic Acid Injection949419
Paradigm 3 / Placebo1001000
Paradigm 4 / Deoxycholic Acid Injection727811
Paradigm 4 / Placebo7510025

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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

,,
Interventionscore on a scale (Mean)
Hour 1Hour 2Day 1Day 2Day 3Day 4
Bupivacaine HCl With Epinephrine1.331.06.54.55.03.0
Exparel005.7532.252.67
Normal Saline72.55.5432

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Number of Participants With Urinary Retention

(NCT02104414)
Timeframe: up to 4 days

,,
InterventionParticipants (Count of Participants)
Day 1Day 2Day 3Day 4
Bupivacaine HCl With Epinephrine0000
Exparel0000
Normal Saline0000

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Postoperative Opioid Consumption - Hydromorphone I.V

(NCT02104414)
Timeframe: 1 hour and 2 hours post op

,,
Interventionmg (Mean)
Hour 1Hour 2
Bupivacaine HCl With Epinephrine00
Exparel0.350.5
Normal Saline0.80.6

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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

,,
InterventionParticipants (Count of Participants)
Day 1Day 2Day 3Day 4
Bupivacaine HCl With Epinephrine1344
Exparel1255
Normal Saline1122

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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

,,
InterventionParticipants (Count of Participants)
Hour 1Hour 2Day 1Day 2Day 3Day 4
Bupivacaine HCl With Epinephrine000000
Exparel000000
Normal Saline000000

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Number of Oxycodone Tablets Taken

Number of postoperative opioid consumption - oxycodone tablets (5mg each) (NCT02104414)
Timeframe: up to 4 days

,,
Interventiontablets (Mean)
Hour 1Hour 2Day 1Day 2Day 3Day 4
Bupivacaine HCl With Epinephrine002.671.671.51
Exparel002.221.42
Normal Saline001.52.52.51.5

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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

Interventionminutes (Mean)
Normal Saline Injection163.6
Ropivacaine With Epinephrine Injection155.3

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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

,
Interventionvials (15mg ketorolac per vial) (Mean)
0 hour1 hour2 hour4 hour6 hour9 hour12 hour24 hour48 hour
Normal Saline Injection10.350.310.070.180.140.180.200.01
Ropivacaine With Epinephrine Injection0.840.310.260.110.150.120.190.160.07

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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

,
Interventionscores on a scale (Mean)
0 hour1 hour2 hour4 hour6 hour9 hour12 hour24 hour48 hour
Normal Saline Injection5.735.054.553.553.393.283.192.932.27
Ropivacaine With Epinephrine Injection5.684.74.113.343.283.143.182.952.08

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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

,
Interventionpoints (Mean)
Swallowing difficultyAnterior neck painRight chest painLeft chest painBack painPosterior neck pain
Normal Saline Injection4.934.503.993.740.651.47
Ropivacaine With Epinephrine Injection4.123.693.164.510.281.65

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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

Interventionml (Mean)
Normal Saline Injection30
Ropivacaine With Epinephrine Injection18

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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

InterventionmmHg (Mean)
Normal Saline Injection91
Ropivacaine With Epinephrine Injection86

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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

Interventionbeats per minute (Mean)
Normal Saline Injection88
Ropivacaine With Epinephrine Injection99

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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

InterventionmmHg (Mean)
Normal Saline Injection142
Ropivacaine With Epinephrine Injection145

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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

InterventionParticipants (Count of Participants)
Rectal Indomethacin Only31
Rectal Indomethacin Plus Papillary Spray of Epinephrine32

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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

InterventionParticipants (Count of Participants)
Rectal Indomethacin Only4
Rectal Indomethacin Plus Papillary Spray of Epinephrine7

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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

InterventionUnits on a scale (Mean)
Paravertebral Block89.5
TAP Block117
Epidural115.5
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

Interventiondays (Mean)
Paravertebral Block1
TAP Block2
Epidural1
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

InterventionDays (Mean)
Paravertebral Block1
TAP Block2
Epidural0.75
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

InterventionDays (Mean)
Paravertebral Block2.66
TAP Block4.33
Epidural4
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

InterventionUnits on a scale (Mean)
Paravertebral Block4.66
TAP Block2.66
Epidural1.75
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

Interventionmcg (Mean)
Paravertebral Block734
TAP Block666
Epidural125
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

Interventiondays (Median)
Standard of Care Analgesia2.0
Liposomal Bupivacaine2.0

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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

Interventionparticipants (Number)
Standard of Care Analgesia2
Liposomal Bupivacaine4

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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

Interventionhours (Median)
Standard of Care Analgesia7.7
Liposomal Bupivacaine11.8

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Change in Short Form-36 (SF-36) Quality of Life Mental Component

Scores on the Medical Outcomes Study 36-Item Short-Form General Health Survey (SF-36). Subjects completed the SF-36 which consists of 8 sub-scales ranging from 0 to 100, with (0 = worst imaginable, 100 = best imaginable). (NCT02242201)
Timeframe: Baseline, 3 months

Interventionunits on a scale (Mean)
PNB Bupivacaine2.2
PAI Ropivacaine2.6
PAI Liposomal Bupivacaine3.0

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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

,,
Interventionunits on a scale (Median)
Pain at restPain with movement
PAI Liposomal Bupivacaine01
PAI Ropivacaine01
PNB Bupivacaine00

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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)

Interventionunits on a scale (Median)
PNB Bupivacaine3.0
PAI Ropivacaine4.0
PAI Liposomal Bupivacaine3.0

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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

,,
InterventionParticipants (Count of Participants)
Operative extremity neurologic changesWound infectionFall requiring medical attention
PAI Liposomal Bupivacaine211
PAI Ropivacaine112
PNB Bupivacaine101

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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

,,
InterventionOral morphine equivalent in milligrams (Median)
PreoperativeIntraoperativePostanesthesia Care Unit (PACU)Post Operative Day (POD) 0 post PACUPOD 1POD 2
PAI Liposomal Bupivacaine1510011.31511.3
PAI Ropivacaine151001533.815
PNB Bupivacaine151007.522.515

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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

,,
InterventionParticipants (Count of Participants)
Pain at restPain with movement
PAI Liposomal Bupivacaine12
PAI Ropivacaine14
PNB Bupivacaine00

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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

,,
Interventionseconds (Median)
Baseline3 months
PAI Liposomal Bupivacaine3030
PAI Ropivacaine3030
PNB Bupivacaine24.530

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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)

Interventiondays (Median)
PNB Bupivacaine2
PAI Ropivacaine2
PAI Liposomal Bupivacaine2

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Change in Short Form-36 (SF-36) Quality of Life Physical Component

Scores on the Medical Outcomes Study 36-Item Short-Form General Health Survey (SF-36). Subjects completed the SF-36 which consists of 8 sub-scales ranging from 0 to 100, with (0 = worst imaginable, 100 = best imaginable). (NCT02242201)
Timeframe: Baseline, 3 months

Interventionunits on a scale (Mean)
PNB Bupivacaine12.5
PAI Ropivacaine12.6
PAI Liposomal Bupivacaine12.3

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Change in Heart Rate

Change from baseline in heart rate. (NCT02285634)
Timeframe: baseline, 30 minutes

Interventionbeats/min (Mean)
Oxymetazoline 0.05%2.8
Phenylephrine 0.25%5.2
Lidocaine 1% Plus Epinephrine 1:100,0007.5
Bacteriostatic 0.9% NaCL6.8

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Change in Diastolic Blood Pressure

Change from baseline in diastolic blood pressure. (NCT02285634)
Timeframe: baseline, 30 minutes

InterventionmmHg (Mean)
Oxymetazoline 0.05%5.7
Phenylephrine 0.25%7.9
Lidocaine 1% Plus Epinephrine 1:100,0006.2
Bacteriostatic 0.9% NaCL9.3

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Change in Systolic Blood Pressure

Change from baseline in systolic blood pressure. (NCT02285634)
Timeframe: baseline, 30 minutes

InterventionmmHg (Mean)
Oxymetazoline 0.05%7.5
Phenylephrine 0.25%8.2
Lidocaine 1% Plus Epinephrine 1:100,0003.5
Bacteriostatic 0.9% NaCL8.9

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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

InterventionmmHg (Mean)
Oxymetazoline 0.05%5.1
Phenylephrine 0.25%6.4
Lidocaine 1% Plus Epinephrine 1:100,0004.6
Bacteriostatic 0.9% NaCL6.5

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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

Interventionunits on a scale (Mean)
Bupivacaine Liposome Suspension2.6
Concentrated Multi Drug Injection3.3

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MS04 Equivalent Consumption

in hospital total MS04 equivalent consumption (NCT02299349)
Timeframe: 1 day following surgery

Interventionmg (Median)
Bupivacaine Liposome Suspension10.0
Concentrated Multi Drug Injection15.0

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Hospital Readmission

Number of participants that were readmitted to the hospital (NCT02365961)
Timeframe: 3 months

InterventionParticipants (Count of Participants)
FI Block1
Local Injection2

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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

Interventionunits on a scale (Mean)
FI Block2.65
Local Injection2.50

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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

InterventionNumber of episodes (Number)
FI Block11
Local Injection7

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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

InterventionMinutes (Mean)
FI Block150.04
Local Injection151.59

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Opioid Consumption

Opioid consumption, as measured by narcotic usage (morphine milligram equivalents) (NCT02365961)
Timeframe: 3 Months

Interventionmorphine milligram equivalents (Mean)
FI Block26.87
Local Injection30.32

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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

Interventionminutes (Median)
Low-dose Epinephrine6
High-dose Epinephrine8
No Epinephrine8

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Motor Recovery

Time to Bromage 3 motor recovery (NCT02369510)
Timeframe: up to 4 hours

Interventionminutes (Median)
Low-dose Epinephrine150
High-dose Epinephrine172
No Epinephrine120

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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

Interventionpercentage of participants (Number)
Low-dose Epinephrine90
High-dose Epinephrine85
No Epinephrine87

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Sensory Recovery

Time to T10 sensory recovery as measured by pinprick sensation (NCT02369510)
Timeframe: up to 3 hours

Interventionminutes (Median)
Low-dose Epinephrine135
High-dose Epinephrine165
No Epinephrine120

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Incidence of Nausea and Vomiting

(NCT02369510)
Timeframe: up to 3 hours

,,
InterventionParticipants (Count of Participants)
2 minutes25 minutes
High-dose Epinephrine06
Low-dose Epinephrine23
No Epinephrine41

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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

Interventionunits on a scale (Median)
Low-dose Epinephrine0
High-dose Epinephrine0
No Epinephrine0

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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

,,
InterventionParticipants (Count of Participants)
2 minutes25 minutes
High-dose Epinephrine29
Low-dose Epinephrine53
No Epinephrine83

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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

Interventionparticipant preference selection (Number)
Injectable32
Topical16

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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

Interventionunits on a scale (Mean)
Injectable0.76
Topical2.82

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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

Interventionunits on a scale (Mean)
Injectable1.47
Topical4.38

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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

Interventionunits on a scale (Mean)
Injectable0.89
Topical3.67

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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

Interventionunit on a scale (Mean)
Upper Lip2.14
Lower Lip1.89

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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

Interventionunits on a scale (Mean)
Upper Lip0.05
Lower Lip0.11

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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

InterventionParticipants (Count of Participants)
4 mg Perineural Dexamethasone Group5
1 mg Perineural Dexamethasone Group14
Placebo Group4

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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

Interventionminutes (Mean)
4 mg Perineural Dexamethasone Group686.18
1 mg Perineural Dexamethasone Group654.97
Placebo Group658.17

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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

,,
Interventionunits on a scale (Mean)
0h6h12h18h24h30h
1 mg Perineural Dexamethasone2.31.32.11.81.83.1
4mg Perineural Dexamethasone2.10.81.71.61.52.4
Placebo2.11.13.03.33.14.3

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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

Interventionhours (Mean)
4 mg Perineural Dexamethasone Group37.00
1 mg Perineural Dexamethasone Group31.75
Placebo Group29.67

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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

Interventionneurological complications (Mean)
4 mg Perineural Dexamethasone Group0
1 mg Perineural Dexamethasone Group0
Placebo Group0

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Post Operative Opioid Use and Consumption

Amount of opioid use and consumption was recorded. (NCT02462148)
Timeframe: 0-30 hours

Interventionmg oxycodone equivalents (Mean)
4 mg Perineural Dexamethasone Group27.16
1 mg Perineural Dexamethasone Group26.04
Placebo Group42.33

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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

Interventionminutes (Median)
4 mg Dexamethasone Group474
8 mg Dexamethasone Group533
Control Group432

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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

Interventionhours (Mean)
4 mg Dexamethasone Group18.5
8 mg Dexamethasone Group18.1
Control Group19.6

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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

Interventionscores on a scale (Median)
4 mg Dexamethasone Group3
8 mg Dexamethasone Group2
Control Group3

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Total Opioid Consumption

(NCT02464176)
Timeframe: 30 hours

Interventionoxycodone mg equivalents (Median)
4 mg Dexamethasone Group36.6
8 mg Dexamethasone Group30
Control Group39.2

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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

InterventionPercentage of Participants (Number)
Short Ragweed Pollen Allergen Extract0.58
Placebo0.20

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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

InterventionScore on a scale (Least Squares Mean)
Short Ragweed Pollen Allergen Extract4.39
Placebo7.12

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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

InterventionPercentage of Participants (Number)
Short Ragween Pollen Allergen Extract0.19
Placebo0.20

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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

InterventionPercentage of Participants (Number)
Short Ragween Pollen Allergen Extract64.52
Placebo26.92

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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

InterventionScore on a scale (Least Squares Mean)
Short Ragweed Pollen Allergen Extract3.88
Placebo5.75

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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

InterventionScore on a scale (Least Squares Mean)
Short Ragweed Pollen Allergen Extract2.55
Placebo3.95

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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

InterventionScore on a scale (Mean)
Short Ragweed Pollen Allergen Extract2.01
Placebo3.85

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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

Interventionscores on a scale (Median)
TAP-Block With Liposomal Bupivacaine8
Surgical Infiltration With Bupivacaine13

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Number of Patients Admitted Post Operatively

(NCT02519023)
Timeframe: 72 hours post-procedure

InterventionParticipants (Count of Participants)
TAP-Block With Liposomal Bupivacaine11
Surgical Infiltration With Bupivacaine16

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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

Interventionscores on a scale (Median)
TAP-Block With Liposomal Bupivacaine2
Surgical Infiltration With Bupivacaine3

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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

Interventionunits on a scale (Median)
TAP-Block With Liposomal Bupivacaine3
Surgical Infiltration With Bupivacaine4

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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

Interventionmg Morphine equivalents (Median)
TAP-Block With Liposomal Bupivacaine20.8
Surgical Infiltration With Bupivacaine25.0

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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

Interventionhours (Median)
TAP-Block With Liposomal Bupivacaine3.3
Surgical Infiltration With Bupivacaine3.1

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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

InterventionParticipants (Count of Participants)
TAP-Block With Liposomal Bupivacaine30
Surgical Infiltration With Bupivacaine24

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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

Interventionunits on a scale (Median)
TAP-Block With Liposomal Bupivacaine2
Surgical Infiltration With Bupivacaine3

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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

Interventionunits on a scale (Median)
TAP-Block With Liposomal Bupivacaine3
Surgical Infiltration With Bupivacaine5

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Number of Participants With Nausea and Vomiting

(NCT02519023)
Timeframe: 72 hours post-procedure

InterventionParticipants (Count of Participants)
TAP-Block With Liposomal Bupivacaine10
Surgical Infiltration With Bupivacaine16

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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

Interventionscores on a scale (Median)
TAP-Block With Liposomal Bupivacaine126
Surgical Infiltration With Bupivacaine115

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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

Interventionmg morphine equivalents (Median)
TAP-Block With Liposomal Bupivacaine0
Surgical Infiltration With Bupivacaine5

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Total Opioid Taken by Patient as Tabulated and Converted to Morphine Equivalents

(NCT02519023)
Timeframe: 0-24 post-procedure

Interventionmg of morphine equivalents (Median)
TAP-Block With Liposomal Bupivacaine7.5
Surgical Infiltration With Bupivacaine22.5

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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

Interventionmg of morphine equivalents (Median)
TAP-Block With Liposomal Bupivacaine0
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

InterventionMorphine equivalents (Median)
Placebo114
0.25 % Bupivacaine w/ Epinephrine & 4mg Dexamethasone92

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Length of Hospital Stay

Number of postoperative days patients stay in the hospital after surgery (NCT02525718)
Timeframe: 4 days

InterventionDays (Median)
Placebo1
0.25 % Bupivacaine w/ Epinephrine & 4mg Dexamethasone1

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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

Interventionscore on a scale (Median)
Placebo4
0.25 % Bupivacaine w/ Epinephrine & 4mg Dexamethasone4

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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

Interventionscore on a scale (Median)
Placebo165
0.25 % Bupivacaine w/ Epinephrine & 4mg Dexamethasone169

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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

Interventionmg (Mean)
PLACEBO31.4
US TAP Bupivacaine/Epinephrine39
Lap TAP Bupivacaine/Epinephrine22.8

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Length of Stay

Measured in hours (NCT02543801)
Timeframe: Start of surgery to hospital discharge up to 140 hours

InterventionHours (Mean)
Hip Cohort Liposomal Bupivacaine33.8
Hip Cohort Ropivacaine50.3
Knee Cohort Liposomal Bupivacaine36.0
Knee Cohort Ropivacaine38.4

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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

Interventionmorphine equivalents (Mean)
Hip Cohort Liposomal Bupivacaine48.8
Hip Cohort Ropivacaine57.4
Knee Cohort Liposomal Bupivacaine52.2
Knee Cohort Ropivacaine50.0

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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

Interventionscore on a scale (Mean)
Hip Cohort Liposomal Bupivacaine3.78
Hip Cohort Ropivacaine3.85
Knee Cohort Liposomal Bupivacaine3.3
Knee Cohort Ropivacaine3.4

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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

,
Interventionmg morphine equivalents (Mean)
0 to 24 hour post surgery period24 to 48 hour post surgery periodFull 48 hour post surgery period
Placebo72.372.8145.7
ROP/KET/CLON/EPI/SAL58.966.5125.6

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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

Interventionunits on a scale (Mean)
Psoas Compartment Block1.9
Periarticular Local Anesthetic1.3

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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

Interventionunits on a scale (Mean)
Psoas Compartment Block4.0
Periarticular Local Anesthetic2.9

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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

Interventionunits on a scale (Mean)
Psoas Compartment Block1.9
Periarticular Local Anesthetic1.7

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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

InterventionMorphine Equivalent Units (Oral) (Mean)
Psoas Compartment Block22.3
Periarticular Local Anesthetic20.8

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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

InterventionMorphine Equivalent Units (Oral) (Mean)
Psoas Compartment Block19.5
Periarticular Local Anesthetic16.7

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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

InterventionOral Morphine Equivalent (mg) (Mean)
Compartment Block101.0
Infiltration115.6

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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

Interventionunits on a scale (Median)
Compartment Block1
Infiltration2

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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

Interventionunits on a scale (Mean)
Compartment Block3
Infiltration4

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The Time to Ambulation

The time to ambulation during 48 hours postoperative period (NCT02658240)
Timeframe: Postoperative 48 hours

InterventionHours (Median)
Compartment Block21.3
Infiltration22

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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

Interventionscore on a scale (Mean)
Bupivacaine With Epinephrine Injections3.66
Liposomal Bupivacaine3.68

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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

InterventionMorphine equivalent dosage per hour (Mean)
Bupivacaine With Epinephrine Injections1.31
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

Interventionhrs (Mean)
Bupivacaine With Epinephrine Injections46.7
Liposomal Bupivacaine29.8

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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

Interventionmg of diazepam/hr (Mean)
Bupivacaine With Epinephrine Injections0.35
Liposomal Bupivacaine0.18

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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

Interventionmg of ondansetron (Mean)
Bupivacaine With Epinephrine Injections7.33
Liposomal Bupivacaine5.75

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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

,
InterventionParticipants (Count of Participants)
Complete Sensory BlockPartial Sensory BlockNo Sensory Block
Posterior Capsular Injection2337
Tibial Nerve Block11124

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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

,
Interventionpain score (Mean)
PACU AdmissionPACU Discharge6th hour12th hour18th hour24th hour30th hour36th hour42nd hour48th hour
Posterior Capsular Injection3.52.11.92.02.32.72.62.53.22.5
Tibial Nerve Block3.21.52.01.23.23.43.02.73.23.4

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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

,
InterventionParticipants (Count of Participants)
Complete Motor BlockPartial Motor BlockNo Motor Block
Posterior Capsular Injection0141
Tibial Nerve Block0432

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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

,
InterventionParticipants (Count of Participants)
Complete Sensory BlockPartial Sensory BlockNo Sensory Block
Posterior Capsular Injection1734
Tibial Nerve Block6273

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Opioid Consumption

Amount of opioid used for the first 24 hours post surgery (NCT02701296)
Timeframe: 24 hours post surgery

Interventionmg (Mean)
Posterior Capsular Injection0.33
Tibial Nerve Block0.42

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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

,
InterventionParticipants (Count of Participants)
Complete Motor BlockPartial Motor BlockNo Motor Block
Posterior Capsular Injection1338
Tibial Nerve Block02511

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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

InterventionmmHG 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

Interventionmg/dL (Mean)
Goal Directed Therapy-0.04
Control Group-0.13

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Fluid Balance Measured by Inputs and Outputs (I/Os) of All Measurable Fluid in Peri-operative Period

Fluid balance measured by I/Os of all fluid in the peri-op period during the first 12 hours after the subject's surgery. (NCT02701582)
Timeframe: Baseline and 12 Hours

Interventionml/kg (Mean)
Goal Directed TherapyNA
Control GroupNA

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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

InterventionParticipants (Count of Participants)
Goal Directed Therapy17
Control Group25

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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

InterventionParticipants (Count of Participants)
Goal Directed Therapy7
Control Group6

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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

Interventionmmol/L (Mean)
Goal Directed Therapy2.0
Control Group1.75

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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

InterventionmEq/L (Mean)
Goal Directed Therapy3.55
Control Group4.75

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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

InterventionParticipants (Count of Participants)
Goal Directed Therapy0
Control Group4

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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

InterventionNumber of ICU Stays greater that 1.5 Day (Number)
Goal Directed Therapy13
Control Group20

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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

Interventionminutes (Median)
Usual Care Group0.8
Hypotension Decision Support1.5

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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

Interventionminutes (Median)
Usual Care Group1
Hypotension Decision Support0.5

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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

Interventionminutes (Median)
Usual Care Group1
Hypotension Decision Support0

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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

Interventionmg/dL (Median)
Usual Care Group0.00
Hypotension Decision Support0.00

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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

Interventionmcg/kg/min (propofol) (Median)
Usual Care Group60.10
Hypotension Decision Support48.59

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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

Interventionmcg/kg/min (propofol) (Median)
Usual Care Group61.07
Hypotension Decision Support50.00

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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

Interventionmcg/kg/min (propofol) (Median)
Usual Care Group63.95
Hypotension Decision Support50.00

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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

InterventionmL (Median)
Usual Care Group1500.00
Hypotension Decision Support1400.00

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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

InterventionParticipants (Count of Participants)
Usual Care Group3632
Hypotension Decision Support792

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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

InterventionParticipants (Count of Participants)
Usual Care Group6989
Hypotension Decision Support1723

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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

InterventionParticipants (Count of Participants)
Usual Care Group13779
Hypotension Decision Support3798

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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

InterventionParticipants (Count of Participants)
Usual Care Group1223
Hypotension Decision Support284

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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

InterventionParticipants (Count of Participants)
Usual Care Group3181
Hypotension Decision Support759

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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

InterventionParticipants (Count of Participants)
Usual Care Group10991
Hypotension Decision Support3045

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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

InterventionParticipants (Count of Participants)
Usual Care Group304
Hypotension Decision Support85

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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

Interventionminutes (Median)
Usual Care Group67
Hypotension Decision Support60

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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

InterventionParticipants (Count of Participants)
Usual Care Group1159
Hypotension Decision Support326

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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

InterventionParticipants (Count of Participants)
Usual Care Group7781
Hypotension Decision Support2196

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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

InterventionParticipants (Count of Participants)
Usual Care Group487
Hypotension Decision Support137

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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

InterventionmL (Median)
Usual Care Group100
Hypotension Decision Support75

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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

InterventionmmHg*minute (Median)
Usual Care Group485
Hypotension Decision Support417

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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

InterventionmmHg*minute (Median)
Usual Care Group273
Hypotension Decision Support235

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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

InterventionmmHg*minute (Median)
Usual Care Group96
Hypotension Decision Support86

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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

InterventionmmHg*minute (Median)
Usual Care Group57
Hypotension Decision Support52

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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

InterventionmmHg*minute (Median)
Usual Care Group23
Hypotension Decision Support23

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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

Interventionmg (Median)
Usual Care Group0.40
Hypotension Decision Support0.40

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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

InterventionmmHg*minute (Median)
Usual Care Group19
Hypotension Decision Support19

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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

Interventionmg (Median)
Usual Care Group0.90
Hypotension Decision Support1.30

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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

Interventionmg (Median)
Usual Care Group0.62
Hypotension Decision Support0.70

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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

Interventionmg (Median)
Usual Care Group1.00
Hypotension Decision Support0.70

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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

Interventionmg (Median)
Usual Care Group20
Hypotension Decision Support15

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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

InterventionParticipants (Count of Participants)
Usual Care Group511
Hypotension Decision Support143

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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

Interventionmcg/kg/min (propofol) (Median)
Usual Care Group65.00
Hypotension Decision Support50.00

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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

,
InterventionEndTidal% (other) (Median)
Sevoflurane (EndTidal %)Isoflurane (EndTidal %)Desflurane (EndTidal %)
Hypotension Decision Support1.270.682.31
Usual Care Group1.350.684.10

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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

,
InterventionEndTidal% (other) (Median)
Sevoflurane (EndTidal %)Isoflurane (EndTidal %)Desflurane (EndTidal %)
Hypotension Decision Support1.250.672.33
Usual Care Group1.350.684.36

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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

,
InterventionEndTidal% (other) (Median)
Sevoflurane (EndTidal %)Isoflurane (EndTidal %)Desflurane (EndTidal %)
Hypotension Decision Support1.250.674.65
Usual Care Group1.340.684.60

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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

,
InterventionEndTidal% (other) (Median)
Sevoflurane (EndTidal %)Isoflurane (EndTidal %)Desflurane (EndTidal %)
Hypotension Decision Support1.230.654.70
Usual Care Group1.320.654.28

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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

InterventionParticipants (Count of Participants)
Usual Care Group12211
Hypotension Decision Support3685

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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

InterventionParticipants (Count of Participants)
Usual Care Group762
Hypotension Decision Support233

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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

InterventionParticipants (Count of Participants)
Usual Care Group11093
Hypotension Decision Support1257

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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

InterventionParticipants (Count of Participants)
Usual Care Group1215
Hypotension Decision Support409

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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

InterventionParticipants (Count of Participants)
Usual Care Group9310
Hypotension Decision Support2718

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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

Interventionminutes (Median)
Usual Care Group2
Hypotension Decision Support1.14

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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

,
Interventionscore on a scale (Mean)
Min Pain within 24hrsMedian Pain within 24 hrsMax Pain within 24 hrs
General Anesthesia and Caudal Nerve Block1.16673.08336.125
General Anesthesia Only0.92863.71436.7857

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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

Interventionmg (Mean)
General Anesthesia and Caudal Nerve Block13.0208
General Anesthesia Only15.1786

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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

InterventionHours (Mean)
General Anesthesia and Caudal Nerve Block24.8424
General Anesthesia Only24.9506

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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)

Interventionpercentage of participants (Number)
Interscalene Block Plus Sham Block39
Interscalene Plus PECS Blocks37

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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.

Interventionunits on a scale (Median)
Interscalene Block Plus Sham Block3
Interscalene Plus PECS Blocks0

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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

InterventionHours (Mean)
Interscalene Plus PECS Blocks16.7

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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

Interventionmg (Mean)
Interscalene Block Plus Sham Block31.6
Interscalene Plus PECS Blocks26.9

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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.

Interventionunits on a scale (Median)
Interscalene Block Plus Sham Block6
Interscalene Plus PECS Blocks6

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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.

Interventionmg of morphine (Mean)
Peri-incisional Injection5.0
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)

,
Interventionunits on a scale (Median)
Pre-opPACU4H8H12H16H20H24H28H32H36H40H44H48H
Control (no Injection)5.03.25.05.05.04.04.04.03.55.04.03.54.03.0
Peri-incisional Injection5.01.61.02.03.53.54.03.03.03.04.03.03.03.0

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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

Interventionmillimeters (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

InterventionEyes (Count of Units)
Epinephrine3
Omidria2

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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

InterventionEyes (Count of Units)
Epinephrine3
Omidria2

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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

Interventionmillimeters * seconds (Mean)
Epinephrine1.76
Omidria0.8

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Pupil Size (mm) Immediately After Nuclear Disassembly

Pupil size immediately after breaking up of cataractous lens (NCT02909140)
Timeframe: Immediately after nuclear disassembly step of cataract surgery

Interventionmm (Number)
Intracameral Mydriasis8

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Pupil Size Immediately Prior to Intraocular Lens (IOL) Insertion

Pupil size after insertion of IOL lens (NCT02909140)
Timeframe: Immediately prior to IOL insertion step of cataract surgery

Interventionmm (Number)
Intracameral Mydriasis8

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Pupil Size Upon Completion of Surgery

(NCT02909140)
Timeframe: intraoperative

Interventionmm (Number)
Intracameral Mydriasis7

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Percentage of Patients in Each Arm That Required Another Mydriatic Agent

(NCT02909140)
Timeframe: intraoperative

Interventionpercent of participants (Number)
Intracameral Mydriasis0

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Pupil Size Immediately Prior to Capsulorrhexis

Pupil size immediately prior to the capsulorrhexis step of cataract surgery. This will be recorded by digital photography and measured by a researcher who is masked to the intervention. (NCT02909140)
Timeframe: Immediately prior to the capsulorrhexis step of cataract surgery

Interventionmm (Number)
Intracameral Mydriasis8

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Mean Time Taken to Perform Phacoemulsification in Each Arm

(NCT02909140)
Timeframe: intraoperative

Interventionseconds (Number)
Intracameral Mydriasis76

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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

InterventionPercent-seconds (Number)
Intracameral Mydriasis6.6

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Mean Time Taken to Perform Phacoemulsification

(NCT02909140)
Timeframe: During cataract surgery

Interventionseconds (Number)
Intracameral Mydriasis76

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Percentage of Patients in Each Arm That Required Use of an Iris Expansion Device During the Procedure

(NCT02909140)
Timeframe: intraoperative

Interventionpercent (Number)
Intracameral Mydriasis50

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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

,
InterventionMilligrams (Median)
Opioid use 24hr post-surgeryTotal inpatient opioid use
Control28.332.7
Peri-incisional Injection25.529.0

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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.

,
Intervention0 to 100 score on a scale (Mean)
Mean VAS score 24hr post-opMean VAS score 48hr post-op
Control5250
Peri-incisional Injection4241

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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.

InterventionHours (Median)
Peri-incisional Injection22.3
Control22.5

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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

InterventionParticipants (Count of Participants)
Peri-incisional Injection49
Control46

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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

Interventionscore on a scale (Mean)
Conscious sedation16.33
Conscious sedation26.45

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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

InterventionParticipants (Count of Participants)
arrhythmia before surgery72559413arrhythmia before surgery72559414arrhythmia during surgery72559413arrhythmia during surgery72559414arrhythmia after surgery72559413arrhythmia after surgery72559414QTc long > 0.45s before surgery72559413QTc long > 0.45s before surgery72559414QTc long > 0.45s during surgery72559413QTc long > 0.45s during surgery72559414QTc long > 0.45s after surgery72559413QTc long > 0.45s after surgery72559414QTc long > 0.45s in the perioperative time72559413QTc long > 0.45s in the perioperative time72559414Additional intervention needed72559414Additional intervention needed72559413
observednot 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

InterventionParticipants (Count of Participants)
Tachycardia < 140 bpm before surgery72559413Tachycardia < 140 bpm before surgery72559414Tachycardia < 140 bpm during surgery72559414Tachycardia < 140 bpm during surgery72559413Tachycardia < 140 bpm after surgery72559413Tachycardia < 140 bpm after surgery72559414Bradycardia before surgery72559414Bradycardia before surgery72559413Bradycardia during surgery72559414Bradycardia during surgery72559413Bradycardia after surgery72559413Bradycardia after surgery72559414Bradycardia in the perioperative period72559414Bradycardia in the perioperative period72559413pause > 2s before surgery72559413pause > 2s before surgery72559414pause > 2s during surgery72559414pause > 2s during surgery72559413pause > 2s after surgery72559414pause > 2s after surgery72559413pause > 2s in the perioperative period72559414pause > 2s in the perioperative period72559413SVE before surgery72559413SVE before surgery72559414SVE during surgery72559413SVE during surgery72559414SVE after surgery72559414SVE after surgery72559413SVE in the perioperativ72559413SVE in the perioperativ72559414VE before surgery72559414VE before surgery72559413VE during surgery72559413VE during surgery72559414VE after surgery72559413VE after surgery72559414VE in the perioperative period72559413VE in the perioperative period72559414Additional intervention needed72559413Additional intervention needed72559414
observednot 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

Interventionunits on a scale (Mean)
Liposomal Bupivacaine3.8
Bupivacaine With Epinephrine3.7

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Number of Patients That Experienced a Fall

(NCT03001453)
Timeframe: 72 hours postoperation

Interventionparticipants (Number)
Liposomal Bupivacaine0
Bupivacaine With Epinephrine0

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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.

InterventionHours (Mean)
Liposomal Bupivacaine46.0
Bupivacaine With Epinephrine44.4

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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

,
Interventionmg (Mean)
0-1212-2424-3636-4848-6060-72Total
Bupivacaine With Epinephrine50.529.621.027.415.420.7121.2
Liposomal Bupivacaine35.128.016.820.623.720.9100.3

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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

Interventionhours (Mean)
Liposomal Bupivacaine10.9
Bupivacaine With Epinephrine14.0

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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

Interventionscore on a scale (Mean)
Ilioinguinal / Iliohypogastric Block3
Quadratus Lumborum Block2.7

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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

Interventionscore on a scale (Mean)
Ilioinguinal / Iliohypogastric Block4.9
Quadratus Lumborum Block5.3

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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

Interventionscore on a scale (Mean)
Ilioinguinal / Iliohypogastric Block5.10
Quadratus Lumborum Block5.03

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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

Interventionminutes (Median)
Ilioinguinal / Iliohypogastric Block141
Quadratus Lumborum Block91

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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

Interventionmilligrams (Mean)
Ilioinguinal / Iliohypogastric Block19.7
Quadratus Lumborum Block25.2

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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

Interventionscore on a scale (Mean)
Ilioinguinal / Iliohypogastric Block3.6
Quadratus Lumborum Block3.3

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Mean Total Postoperative Opioid Consumption (in Morphine Equivalents)

(NCT03011333)
Timeframe: 72 Hours

InterventionMorphine milligram equivalents (MME) (Mean)
Group 1: HTX-01138.71
Group 2: HTX-01124.39
Group 3: HTX-01138.00
Group 4: HTX-01128.84
Group 5: HTX-01137.46
Group 6: Bupivacaine HCl33.57
Group 7: Saline Placebo36.38

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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

Interventionpain intensity score*hr (Mean)
Group 1: HTX-011124.51
Group 2: HTX-011136.17
Group 3: HTX-011136.76
Group 4: HTX-011116.71
Group 5: HTX-011114.87
Group 6: Bupivacaine HCl133.83
Group 7: Saline Placebo151.52

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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

InterventionmL (Mean)
IVC Ultrasound-guided7,300
Usual Care7,702

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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

InterventionScore on a scale (Median)
IVC Ultrasound-guided1
Usual Care1

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30-day Mortality

30-day mortality related to septic shock (NCT03020407)
Timeframe: 30 day after randomization

InterventionParticipants (Count of Participants)
IVC Ultrasound-guided20
Usual Care19

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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

InterventionmL (Median)
IVC Ultrasound-guided1900
Usual Care2600

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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

Interventionpercentage change (Median)
IVC Ultrasound-guided39.2
Usual Care35.9

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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

Interventionminutes (Mean)
Traditional Technique Group33.9
Electric Stimulation Group24.0

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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

InterventionParticipants (Count of Participants)
Traditional Technique Group41
Electric Stimulation Group45

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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

Interventionmillimeters (Mean)
Active Tymbion Iontophoresis4.2
Sham Tymbion Iontophoresis18.3

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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

Interventionscore on a scale (Mean)
Oxymetazoline3
Epinephrine2.55

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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

Interventionhr*pg/ml (Mean)
Emerade 300mcg Injection174
Emerade 500mcg Injection387
Epipen 0.3mg203

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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

Interventionpg/ml (Mean)
Emerade 300mcg Injection218
Emerade 500mcg Injection394
Epipen 0.3mg290

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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

Interventionminutes (Mean)
Emerade 300mcg Injection9.6
Emerade 500mcg Injection8.5
Epipen 0.3mg5.9

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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

,,
InterventionParticipants (Count of Participants)
Pain at injection siteSystemic AE (any)PalpitationsTremor
Emerade 300mcg Injection8433
Emerade 500mcg Injection6947
Epipen 0.3mg7838

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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

Interventionmg of supplemental oxycodone (Mean)
Bupivacaine 0.25%19
Bupivacaine 0.25% + Epinephrine25
Saline Solution23

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Opioid Consumption (Oral Morphine Equivalents)

Total oral morphine equivalent consumption calculated (NCT03408483)
Timeframe: immediately postoperatively to 48 hours postoperatively

Interventionmg of morphine equivalents (Mean)
Quadratus Lumborum Block (QLB)54.63
Standard of Care90.76

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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

Interventionunits on a scale (Mean)
Quadratus Lumborum Block (QLB)2.34
Standard of Care3.33

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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

Interventionunits on a scale (Mean)
Quadratus Lumborum Block (QLB)2.31
Standard of Care4.06

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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

Interventionunits on a scale (Mean)
Quadratus Lumborum Block (QLB)3.33
Standard of Care4.11

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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

Interventionscore on a scale (Mean)
Quadratus Lumborum Block (QLB)2.34
Standard of Care3.33

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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

Interventionscore on a scale (Mean)
Quadratus Lumborum Block (QLB)9.14
Standard of Care7.46

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Distance Ambulated

Physical therapist documentation of ambulation distance measured in feet (NCT03408483)
Timeframe: 24 hours

Interventionfeet (Mean)
Quadratus Lumborum Block (QLB)114.51
Standard of Care100.85

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Distance Ambulated

Physical therapist documentation of ambulation distance measured in feet (NCT03408483)
Timeframe: 48 hours

Interventionfeet (Mean)
Quadratus Lumborum Block (QLB)127.75
Standard of Care106.69

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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

Interventionhours (Mean)
Quadratus Lumborum Block (QLB)53.17
Standard of Care55.97

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Opioid Consumption (Oral Morphine Equivalents)

Total oral morphine equivalent consumption calculated (NCT03408483)
Timeframe: from 24 hours to 48 hours postoperatively

Interventionmg of morphine equivalents (Mean)
Quadratus Lumborum Block (QLB)24.26
Standard of Care40.52

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Opioid Consumption (Oral Morphine Equivalents)

Total oral morphine equivalent consumption calculated (NCT03408483)
Timeframe: immediately postoperatively to 24 hours postoperatively

Interventionmg of morphine equivalents (Mean)
Quadratus Lumborum Block (QLB)30.05
Standard of Care47.14

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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

Interventionminutes (Mean)
Buffered Anesthetic3.4
Unbuffered Anesthetic4.4

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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

Interventionminutes (Mean)
Buffered Anesthetic218
Unbuffered Anesthetic241

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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

Interventionscore on a scale (Mean)
Buffered Anesthetic3.0
Unbuffered Anesthetic3.3

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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

Interventionmcg/ml (Mean)
Buffered Anesthetic243.5
Unbuffered Anesthetic600.2

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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

Interventionscore 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

Interventionscore on a scale (Geometric Least Squares Mean)
Group 1. Breg Cooling Control17.18
Group 2. Gel Pack Cooling18.26
Group 3. Shortened Gel Pack Cooling16.48
Group 4. Single Needle Injection Gel Pack Cooling - 2% Lidocaine17.40
Group 5. Single Needle Injection Gel Pack Cooling - 1% Lidocaine16.00

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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

Interventionscore on a scale (Least Squares Mean)
Single Knee Injection (Unilateral Mod-Sev OA Knee Pain) INDEX KNEE17.15
Single Knee Injection (Non-Index Knee PJR/TJR) INDEX KNEE20.41
Bilateral Knee Injection (Bilateral Mod-Sev OA Knee Pain) INDEX KNEE20.05
Bilateral Knee Injection (Bilateral Mod-Sev OA Knee Pain) NON-INDEX KNEE18.40

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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

Interventionscore on a scale (Least Squares Mean)
Single Knee Injection (Unilateral Mod-Sev OA Knee Pain) INDEX KNEE21.08
Single Knee Injection (Non-Index Knee PJR/TJR) INDEX KNEE25.26
Bilateral Knee Injection (Bilateral Mod-Sev OA Knee Pain) INDEX KNEE25.85
Bilateral Knee Injection (Bilateral Mod-Sev OA Knee Pain) NON-INDEX KNEE23.34

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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

Interventionscore on a scale (Least Squares Mean)
Single Knee Injection (Unilateral Mod-Sev OA Knee Pain) INDEX KNEE22.45
Single Knee Injection (Non-Index Knee PJR/TJR) INDEX KNEE23.90
Bilateral Knee Injection (Bilateral Mod-Sev OA Knee Pain) INDEX KNEE25.62
Bilateral Knee Injection (Bilateral Mod-Sev OA Knee Pain) NON-INDEX KNEE22.10

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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

Interventionscore on a scale (Least Squares Mean)
Single Knee Injection (Unilateral Mod-Sev OA Knee Pain) INDEX KNEE22.10
Single Knee Injection (Non-Index Knee PJR/TJR) INDEX KNEE16.75
Bilateral Knee Injection (Bilateral Mod-Sev OA Knee Pain) INDEX KNEE21.52
Bilateral Knee Injection (Bilateral Mod-Sev OA Knee Pain) NON-INDEX KNEE19.40

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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

Interventionscore on a scale (Least Squares Mean)
Single Knee Injection (Unilateral Mod-Sev OA Knee Pain) INDEX KNEE25.17
Single Knee Injection (Non-Index Knee PJR/TJR) INDEX KNEE33.11
Bilateral Knee Injection (Bilateral Mod-Sev OA Knee Pain) INDEX KNEE27.80
Bilateral Knee Injection (Bilateral Mod-Sev OA Knee Pain) NON-INDEX KNEE24.80

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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

Interventionscore on a scale (Least Squares Mean)
Single Knee Injection (Unilateral Mod-Sev OA Knee Pain) INDEX KNEE20.86
Single Knee Injection (Non-Index Knee PJR/TJR) INDEX KNEE25.66
Bilateral Knee Injection (Bilateral Mod-Sev OA Knee Pain) INDEX KNEE25.57
Bilateral Knee Injection (Bilateral Mod-Sev OA Knee Pain) NON-INDEX KNEE22.26

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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

Interventionscore on a scale (Median)
Exparel4.8
Marcaine5.2

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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

InterventionParticipants (Count of Participants)
Exparel0
Marcaine0

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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

InterventionUnited States Dollars (Median)
Exparel22,775
Marcaine20,252

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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

InterventionMEq (Median)
Exparel48
Marcaine42.7

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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

InterventionParticipants (Count of Participants)
Exparel8
Marcaine5

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Pharmacy Cost

Median In-hospital pharmacy cost (NCT03682224)
Timeframe: In-hospital until discharge, approximately 3 days

InterventionUnited States Dollars (Median)
Exparel1052
Marcaine596

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Hospital Stay

(NCT03682224)
Timeframe: Length of hospital stay - from admission to discharge, approximately 3 days

InterventionDays (Median)
Exparel3.28
Marcaine2.45

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Atrial Fibrillation/Other Arrhythmia

Post-op arrhythmia (NCT03682224)
Timeframe: In-hospital until discharge, approximately 3 days

InterventionParticipants (Count of Participants)
Exparel2
Marcaine3

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Pneumothorax

Documented pnuemothorax (NCT03682224)
Timeframe: In-hospital until discharge, approximately 3 days

InterventionParticipants (Count of Participants)
Exparel5
Marcaine6

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Cumulative 48-hour Post Surgical Opiate Use (Oral Morphine Equivalent)

(NCT03723447)
Timeframe: 48-hours

InterventionOral morphine equivalents (Median)
Bupivacaine/Epinephrine/Dexamethasone TAP Block47
Liposomal Bupivacaine TAP Block69

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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

Interventionscore on a scale (Median)
Bupivacaine/Epinephrine/Dexamethasone TAP Block4
Liposomal Bupivacaine TAP Block4

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Postoperative Length of Stay

Time from operation until hospital discharge (NCT03723447)
Timeframe: 30 days post-surgery

Interventiondays (Median)
Bupivacaine/Epinephrine/Dexamethasone TAP Block3
Liposomal Bupivacaine TAP Block3

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Bowel Motility

Time till first bowel movement (NCT03723447)
Timeframe: 72 hours post-surgery

Interventiondays (Median)
Bupivacaine/Epinephrine/Dexamethasone TAP Block1
Liposomal Bupivacaine TAP Block1

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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

InterventionParticipants (Count of Participants)
POD472268834POD472268835POD6072268834POD6072268835
10/10below 10Missing data
Liposomal Bupivacaine 1.3%32
Bupivacaine 0.5% With Adjuncts24
Liposomal Bupivacaine 1.3%9
Bupivacaine 0.5% With Adjuncts17
Liposomal Bupivacaine 1.3%4
Bupivacaine 0.5% With Adjuncts1
Liposomal Bupivacaine 1.3%27
Bupivacaine 0.5% With Adjuncts28
Liposomal Bupivacaine 1.3%12
Bupivacaine 0.5% With Adjuncts13
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

,
Interventionunits on a scale 0-10 (Median)
PACUPACU-24 hours MinimumPACU-24 hours MaximumPACU-24 hours Average24-48 hours Minimum24-48 hours Maximum24-48 hours Average48-72 hours Minimum48-72 hours Maximum48-72 hours Average72-96 hours Minimum72-96 hours Maximum72-96 hours Average60 days postoperative Maximum60 days postoperative Average60 days postoperative Minimum
Bupivacaine 0.5% With Adjuncts0.000.001.000.002.007.004.002.006.003.002.005.003.006.002.000.00
Liposomal Bupivacaine 1.3%0.000.002.001.000.004.502.001.004.002.000.504.002.005.001.000.00

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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

Interventionday (Median)
Liposomal Bupivacaine 1.3%4
Bupivacaine 0.5% With Adjuncts4

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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.

Interventionhour (Median)
Liposomal Bupivacaine 1.3%31.05
Bupivacaine 0.5% With Adjuncts31.63

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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.

Interventionhours (Median)
Liposomal Bupivacaine 1.3%10.5667
Bupivacaine 0.5% With Adjuncts12.025

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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

InterventionMME (Median)
Liposomal Bupivacaine 1.3%71.25
Bupivacaine 0.5% With Adjuncts90.30

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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.

,
InterventionParticipants (Count of Participants)
Any movement in PACUAny movement in day1Any movement after day1Any movement missing dataReturn of full movement day 2-60Not yet by day 60Return of full movement missing data
Bupivacaine 0.5% With Adjuncts1132923168
Liposomal Bupivacaine 1.3%1438232310

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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

InterventionParticipants (Count of Participants)
PACU distress72268834PACU distress72268835POD2 Distress72268834POD2 Distress72268835
No distressany distressMissing data
Liposomal Bupivacaine 1.3%31
Bupivacaine 0.5% With Adjuncts31
Liposomal Bupivacaine 1.3%14
Bupivacaine 0.5% With Adjuncts14
Liposomal Bupivacaine 1.3%0
Bupivacaine 0.5% With Adjuncts0
Liposomal Bupivacaine 1.3%32
Liposomal Bupivacaine 1.3%12
Bupivacaine 0.5% With Adjuncts12
Liposomal Bupivacaine 1.3%1
Bupivacaine 0.5% With Adjuncts2

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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

InterventionParticipants (Count of Participants)
Full sensation72268834Full sensation72268835First sensation72268834First sensation72268835
Returned on day 1 after the blockReturned on day 2-60Not by day 60Missing data
Liposomal Bupivacaine 1.3%11
Bupivacaine 0.5% With Adjuncts11
Liposomal Bupivacaine 1.3%27
Bupivacaine 0.5% With Adjuncts27
Liposomal Bupivacaine 1.3%0
Bupivacaine 0.5% With Adjuncts2
Liposomal Bupivacaine 1.3%7
Bupivacaine 0.5% With Adjuncts5
Liposomal Bupivacaine 1.3%35
Bupivacaine 0.5% With Adjuncts33
Liposomal Bupivacaine 1.3%9
Bupivacaine 0.5% With Adjuncts10
Bupivacaine 0.5% With Adjuncts0
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.

,
InterventionMME/day (Median)
0-24 hours24-48 hours48-72 hours72-120 hours
Bupivacaine 0.5% With Adjuncts25.0023.255.0015.00
Liposomal Bupivacaine 1.3%25.0016.002.0010.00

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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)

Interventionunits on a scale (Mean)
Corticosteroid With Lidocaine With Epinephrine1.2
Corticosteroid With Normal Saline1

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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)

Interventionscore on a scale (Mean)
Corticosteroid With Lidocaine With Epinephrine3.5
Corticosteroid With Normal Saline2

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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

,
InterventionPolyps (Number)
En bloc removalPiecemeal removal
Epinephrine011
No Epinephrine010

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Frequency of Immediate Bleeding

Number of polyps with intraprocedural bleeding during removal (NCT04065451)
Timeframe: During the colonoscopy procedure, an average of 47.3 minutes

,
InterventionPolyps (Count of Units)
BleedingNo bleeding
Epinephrine29
No Epinephrine46

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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

,
InterventionPolyps (Count of Units)
Excellent/adequateinsufficientUnknown
Epinephrine902
No Epinephrine820

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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

Interventionunits on a scale (Mean)
Epinephrine46.5
No Epinephrine13.6

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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

InterventionUnits on a Scale (Mean)
Epinephrine44
No Epinephrine12.9

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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

InterventionRatio (Median)
Epinephrine5
No Epinephrine4.2

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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.

InterventionParticipants (Count of Participants)
Single LET4
Triple LET5

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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

Interventionmm (Mean)
Single LET16
Triple LET16

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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.

Interventionpg/mL (Geometric Mean)
Primatene Mist, E004240.8
Epinephrine Injection Auto-Injector (Generic of EpiPen)704.8
Albuterol HFA599.8

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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.

Interventionpg/mL x hr (Geometric Mean)
Primatene Mist, E00426.8
Epinephrine Injection Auto-Injector (Generic of EpiPen)509.9
Albuterol HFA3332.3

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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.

Interventionpg/mL x hr (Geometric Mean)
Primatene Mist, E00418.4
Epinephrine Injection Auto-Injector (Generic of EpiPen)396.3
Albuterol HFA3332.3

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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.

Interventionpg/mL x hr (Geometric Mean)
Primatene Mist, E00418.4
Epinephrine Injection Auto-Injector (Generic of EpiPen)411.4
Albuterol HFA3650.4

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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.

Interventionmin (Geometric Mean)
Primatene Mist, E0042.6
Epinephrine Injection Auto-Injector (Generic of EpiPen)8.3
Albuterol HFA21.8

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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.

Interventionmin (Geometric Mean)
Primatene Mist, E0047.1
Epinephrine Injection Auto-Injector (Generic of EpiPen)138.8
Albuterol HFA420.7

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Time Until First Opioid Request

(NCT04369950)
Timeframe: Up to 48 hours after epidural morphine administration

Interventionhours (Median)
2 Percent Lidocaine With Epinephrine and Epidural Morphine14.8
3 Percent 2-Chloroprocaine and Epidural Morphine24.7

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Total Amount of Opioid Used

(NCT04369950)
Timeframe: 12 hours after epidural morphine administration

Interventionhours (Median)
2 Percent Lidocaine With Epinephrine and Epidural Morphine0
3 Percent 2-Chloroprocaine and Epidural Morphine0

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Total Amount of Opioid Used

(NCT04369950)
Timeframe: 24 hours after epidural morphine administration

Interventionmilligrams (Median)
2 Percent Lidocaine With Epinephrine and Epidural Morphine15
3 Percent 2-Chloroprocaine and Epidural Morphine0

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Total Amount of Opioid Used

(NCT04369950)
Timeframe: 4 hours after epidural morphine administration

Interventionhours (Median)
2 Percent Lidocaine With Epinephrine and Epidural Morphine0
3 Percent 2-Chloroprocaine and Epidural Morphine0

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Total Amount of Opioid Used

(NCT04369950)
Timeframe: 8 hours after epidural morphine administration

Interventionhours (Median)
2 Percent Lidocaine With Epinephrine and Epidural Morphine0
3 Percent 2-Chloroprocaine and Epidural Morphine0

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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

,
InterventionParticipants (Count of Participants)
4 hours8 hours12 hours24 hours
2 Percent Lidocaine With Epinephrine and Epidural Morphine3100
3 Percent 2-Chloroprocaine and Epidural Morphine1200

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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

,
InterventionParticipants (Count of Participants)
4 hours8 hours12 hours24 hours
2 Percent Lidocaine With Epinephrine and Epidural Morphine7642
3 Percent 2-Chloroprocaine and Epidural Morphine3430

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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

,
Interventionscore on a scale (Median)
4 hours8 hours12 hours24 hours
2 Percent Lidocaine With Epinephrine and Epidural Morphine0037
3 Percent 2-Chloroprocaine and Epidural Morphine2.5123.5

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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

InterventionMinutes (Mean)
Control4.2
Intervention2.2

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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

InterventionBeats Per Minute (Mean)
Control91.5
Intervention93.4

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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

Interventionmmhg (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)

Interventionminutes (Mean)
Treatment62
Control Group64

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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)

Interventionscore on a scale (Mean)
Treatment8.3
Control Group7.5

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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)

Interventionpercent (Number)
Treatment22
Control Group23

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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)

InterventionParticipants (Count of Participants)
Treatment0
Control Group0

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Intraoperative Mean Arterial Pressure

(NCT05244525)
Timeframe: end of surgery(about 30-120 minutes from start of surgery)

InterventionmmHg (Mean)
Treatment70.5
Control Group71.3

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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

InterventionParticipants (Count of Participants)
Treatment0
Control Group0

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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?)

,,
InterventionRp:Rs ratio (Mean)
BaselineApprox. 2 minutes following drug administration
Arginine Vasopressin0.750.49
Epinephrine0.610.6
Phenylephrine0.80.73

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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)

Interventionnostrils (Count of Units)
1:1000 Epinephrine Plus Saline7
1:1000 Epinephrine Plus Infiltration of 1% Lidocaine With 1:100,000 Epinephrine5

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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)

Interventionscore on a scale (Mean)
1:1000 Epinephrine Plus Saline2.38
1:1000 Epinephrine Plus Infiltration of 1% Lidocaine With 1:100,000 Epinephrine2.2

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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)

Interventionscore on a scale (Mean)
1:1000 Epinephrine Plus Saline3.54
1:1000 Epinephrine Plus Infiltration of 1% Lidocaine With 1:100,000 Epinephrine3.23

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Estimated Blood Loss During Surgery

(NCT05867342)
Timeframe: intraoperatively (up to 3 hours)

InterventionmL (Mean)
1:1000 Epinephrine Plus Saline95.25
1:1000 Epinephrine Plus Infiltration of 1% Lidocaine With 1:100,000 Epinephrine91.63

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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)

Interventiondays (Mean)
1:1000 Epinephrine Plus Saline2.85
1:1000 Epinephrine Plus Infiltration of 1% Lidocaine With 1:100,000 Epinephrine2.73

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Duration of Surgery

(NCT05867342)
Timeframe: intraoperatively (up to 3 hours)

Interventionminutes (Mean)
1:1000 Epinephrine Plus Saline72.05
1:1000 Epinephrine Plus Infiltration of 1% Lidocaine With 1:100,000 Epinephrine54.23

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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)

Interventionpledgets (Mean)
1:1000 Epinephrine Plus Saline3.25
1:1000 Epinephrine Plus Infiltration of 1% Lidocaine With 1:100,000 Epinephrine2.63

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