Page last updated: 2024-12-05

chloroprocaine

Description Research Excerpts Clinical Trials Roles Classes Pathways Study Profile Bioassays Related Drugs Related Conditions Protein Interactions Research Growth Market Indicators

Description

chloroprocaine: RN given refers to parent cpd; structure [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

chloroprocaine : Procaine in which one of the hydrogens ortho- to the carboxylic acid group is substituted by chlorine. It is used as its monohydrochloride salt as a local anaesthetic, particularly for oral surgery. It has the advantage over lidocaine of constricting blood vessels, so reducing bleeding. [Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Cross-References

ID SourceID
PubMed CID8612
CHEMBL ID1179047
CHEBI ID3636
SCHEMBL ID6676
MeSH IDM0045735

Synonyms (54)

Synonym
AKOS010575135
2-(diethylamino)ethyl 4-amino-2-chlorobenzoate
hsdb 3301
cloroprocaina [inn-spanish]
chloroprocaine [inn]
chlorprocainum
chlor-procaine
halestyn
piocaine
2-(diethylaminoethyl)-4-amino-2-chlorobenzoate
brn 2808071
chloroprocainum [inn-latin]
benzoic acid, 4-amino-2-chloro-, 2-(diethylamino)ethyl ester
D07678
chloroprocaine (inn)
chloroprocaine
C07877
133-16-4
chloroprocain
4-amino-2-chlorobenzoic acid 2-(diethylamino)ethyl ester
chlorprocaine
DB01161
2-chloroprocaine
2-diethylaminoethyl 4-amino-2-chlorobenzoate
chloroprocainum
CHEBI:3636 ,
cloroprocaina
2-diethylaminoethyl 4-amino-2-chloro-benzoate
CHEMBL1179047
5yvb0pot2h ,
4-14-00-01273 (beilstein handbook reference)
unii-5yvb0pot2h
chloroprocaine [vandf]
chloroprocaine [hsdb]
chloroprocaine [who-dd]
chloroprocaine [mi]
gtpl7145
SCHEMBL6676
VDANGULDQQJODZ-UHFFFAOYSA-N
DTXSID8022799 ,
SR-01000944416-1
sr-01000944416
FT-0713386
Q2964133
NCGC00183273-04
CS-0013537
HY-B1604A
dtxcid902799
n01ba04
cloroprocaina (inn-spanish)
nescaine
chloroprocainum (inn-latin)
EN300-1590375
Z802864938

Research Excerpts

Overview

Chloroprocaine is a short-acting local anesthetic that helps patients ambulate more quickly after surgery due to its 60-minute average duration of action. It is an effective local anaesthetic in the erector spinae compartment, which has not been previously reported.

ExcerptReferenceRelevance
"Chloroprocaine is a short-acting local anesthetic that has been used for spinal anesthesia in outpatient surgery. "( ED 90 of Intrathecal Chloroprocaine With Fentanyl for Prophylactic Cervical Cerclage: A Sequential Allocation Biased-Coin Design.
Diomede, OI; Fuller, ME; Habib, AS; Landreth, RA; Martinello, C; Mhyre, JM; Sharawi, N; Tan, HS; Taylor, C; Williams, M, 2022
)
2.48
"2-Chloroprocaine is a short-acting local anesthetic that helps patients ambulate more quickly after surgery due to its 60-minute average duration of action."( Spinal Anesthesia with 2-Chloroprocaine and Dexmedetomidine for Cesarean Section: A Case Report.
Baribeault, T; Suss, S, 2023
)
1.77
"Chloroprocaine is an effective local anaesthetic in the erector spinae compartment, which has not been previously reported."( Erector spinae catheter for post-thoracotomy pain control in a premature neonate.
Flaherty, J; Hess, D; Horvath, B; Swenson Schalkwyk, A, 2020
)
1.28
"Chloroprocaine is a short-acting local anaesthetic with a rapid onset of action and an anaesthesia duration up to 60 min. "( A randomised, non-inferiority study of chloroprocaine 2% and ropivacaine 0.75% in ultrasound-guided axillary block.
Camponovo, C; Donati, E; Haslik, W; Kimberger, O; Köstenberger, M; Leuratti, C; Likar, R; Sulyok, I; Zotti, O, 2021
)
2.33
"2-Chloroprocaine is a local anesthetic with a very short half-life and a favorable evolution of spinal block for ultra-short outpatient procedures. "( Spinal 1% 2-Chloroprocaine versus general anesthesia for ultra-short outpatient procedures: a retrospective analysis.
Camponovo, C, 2014
)
1.5
"Chloroprocaine is a local ester anesthetic, producing excellent sensory block in clinical use. "( Inhibition of Kv7/M Channel Currents by the Local Anesthetic Chloroprocaine.
Cheng, Y; Jia, Q; Li, H; Zhang, F; Zhang, H; Zhao, S, 2015
)
2.1
"Chloroprocaine is an ester local anesthetic that has an extremely short plasma half-life in infants as well as adults."( Continuous chloroprocaine infusion for thoracic and caudal epidurals as a postoperative analgesia modality in neonates, infants, and children.
Aldrink, J; Bhalla, T; Iliev, P; Martin, D; Tobias, J; Tripi, J; Veneziano, G, 2016
)
1.55
"Chloroprocaine is a fast-acting local anesthetic, whereas bupivacaine is a long-acting one. "( Bicarbonate plus epinephrine shortens the onset and prolongs the duration of sciatic block using chloroprocaine followed by bupivacaine in sprague-dawley rats.
Jafari, S; Lahoti, T; Ray, SD; Schianodicola, JJ; Weinberg, JD; Yarmush, JM; Yung, E,
)
1.79

Effects

Chloroprocaine has a short duration of action and has re-emerged as an agent for ambulatory neuraxial anesthesia. It has a rapid hydrolysis in the bloodstream by pseudocholinesterase.

Chloroprocaine has a short duration of action and has re-emerged as an agent for ambulatory neuraxial anesthesia. 2-Chloriprocaine (CP) has been recommended as a less toxic alternative to amide-type local anesthetics due to its rapid metabolism.

ExcerptReferenceRelevance
"Chloroprocaine has a short duration of action and has re-emerged as an agent for ambulatory neuraxial anesthesia."( Intrathecal bupivacaine versus chloroprocaine for transvaginal cervical cerclage placement: a retrospective cohort study.
Fuller, M; Habib, AS; Mims, SC; Zanolli, NC, 2022
)
1.73
"2-Chloroprocaine has a rapid onset of action, producing an excellent sensory and motor block and has a rapid hydrolysis in the bloodstream by pseudocholinesterase."( Randomised controlled trial of spinal anaesthesia with bupivacaine or 2-chloroprocaine during caesarean section.
Laubach, M; Maes, S; Poelaert, J, 2016
)
1.22
"Chloroprocaine has a short duration of action and has re-emerged as an agent for ambulatory neuraxial anesthesia."( Intrathecal bupivacaine versus chloroprocaine for transvaginal cervical cerclage placement: a retrospective cohort study.
Fuller, M; Habib, AS; Mims, SC; Zanolli, NC, 2022
)
1.73
"Chloroprocaine has been demonstrated to be associated with a lower risk of transient neurologic symptoms compared with lidocaine. "( Spinal anesthesia revisited: toxicity of new and old drugs and compounds.
Hampl, K; Steinfeldt, T; Wulf, H, 2014
)
1.85
"2-Chloroprocaine has a rapid onset of action, producing an excellent sensory and motor block and has a rapid hydrolysis in the bloodstream by pseudocholinesterase."( Randomised controlled trial of spinal anaesthesia with bupivacaine or 2-chloroprocaine during caesarean section.
Laubach, M; Maes, S; Poelaert, J, 2016
)
1.22
"2-Chloroprocaine (CP) has recently been recommended as a less toxic alternative to amide-type local anesthetics due to its rapid metabolism. "( Comparison of lidocaine and 2-chloroprocaine in paracervical block: clinical effects and drug concentrations in mother and child.
Almonte, RO; Gundersen, K; Halevy, S; Hinsvark, ON; O'Brien, JE; Weiss, RR, 1983
)
1.28
"Chloroprocaine has been associated with severe back pain after epidural anesthesia. "( Back pain after epidural anesthesia with chloroprocaine.
Kao, TC; Stevens, RA; Urmey, WF; Urquhart, BL, 1993
)
1.99

Toxicity

ExcerptReferenceRelevance
"2% BS was not toxic to peripheral nerves."( Peripheral neurotoxicity of 2-chloroprocaine and bisulfite in the cat.
Ford, DJ; Raj, PP, 1987
)
0.56
" Shorter exposure times (3 hr) resulted in a marginal toxic effect (32%)."( Toxicity of chloroprocaine and sodium bisulfite on human neuroblastoma cells.
Lear, E; Seravalli, E, 1987
)
0.65
" Prilocaine produced the predetermined toxic end-points (i."( Comparison of acute central nervous system and cardiovascular toxicity of 2-chloroprocaine and prilocaine in the rat.
Heavner, JE; Rosenberg, PH; Zou, J, 1993
)
0.52
" This may contribute to a further increase in the safe use of spinal anesthesia in the clinical setting."( Spinal anesthesia revisited: toxicity of new and old drugs and compounds.
Hampl, K; Steinfeldt, T; Wulf, H, 2014
)
0.4

Pharmacokinetics

The in vitro half-life of chloroprocaine (11-21 seconds) has been cited to support the safety of this approach. The primary objective was to define the pharmacokinetic profile of intraperitoneal chloroprocaine.

ExcerptReferenceRelevance
" The short in vitro half-life of chloroprocaine (11-21 seconds) has been cited to support the safety of this approach."( Pharmacokinetics and Tolerability of Intraperitoneal Chloroprocaine After Fetal Extraction in Women Undergoing Cesarean Delivery.
Bleyle, LA; Brookfield, K; Koop, D; Togioka, BM; Treggiari, MM; Yanez, ND; Zarnegarnia, Y, 2022
)
1.25
" The primary objective was to define the pharmacokinetic profile of intraperitoneal chloroprocaine, including in vivo half-life."( Pharmacokinetics and Tolerability of Intraperitoneal Chloroprocaine After Fetal Extraction in Women Undergoing Cesarean Delivery.
Bleyle, LA; Brookfield, K; Koop, D; Togioka, BM; Treggiari, MM; Yanez, ND; Zarnegarnia, Y, 2022
)
1.2
"The in vivo half-life of intraperitoneal chloroprocaine (5."( Pharmacokinetics and Tolerability of Intraperitoneal Chloroprocaine After Fetal Extraction in Women Undergoing Cesarean Delivery.
Bleyle, LA; Brookfield, K; Koop, D; Togioka, BM; Treggiari, MM; Yanez, ND; Zarnegarnia, Y, 2022
)
1.24

Dosage Studied

Pregnant patient may be dosed in the lateral supine position without adversely affecting the caudad or cephalad spread of plain or pH-adjusted 2% 2-chloroprocaine. The aim of this trial was to determine the optimal dosage of chloroprocane for this indication.

ExcerptRelevanceReference
" There was no significant difference between groups in median duration of subsequent bupivacaine analgesia (60 min in each group) or mean (+/- SD) dosage of bupivacaine during the first stage of labor (64 +/- 43 versus 72 +/- 57 mg)."( The influence of pH-adjusted 2-chloroprocaine on the quality and duration of subsequent epidural bupivacaine analgesia during labor: a randomized, double-blind study.
Bates, JN; Chestnut, DH; Choi, WW; Geiger, M, 1989
)
0.56
" Our results indicate that a pregnant patient may be dosed in the lateral supine position without adversely affecting the caudad or cephalad spread of plain or pH-adjusted 2% 2-chloroprocaine, which is clinically important because the incidence of aortocaval compression is increased in the supine position when compared with the lateral supine position."( The effect of pH-adjusted 2-chloroprocaine on the onset of epidural analgesia in pregnant patients in the lying and sitting position during the first stage of labor.
Ackerman, WE; Denson, DD; Juneja, MM; Kaczorowski, DM; Nicholson, CJ; Sarracino, SM; Schipper, J, 1989
)
0.76
" Cardiotoxicity associated with bupivacaine is related not to the concentration employed but to the total dosage administered as a rapid intravenous injection."( Is there a need for chloroprocaine 3% and bupivacaine 0.75%?
Covino, BG, 1988
)
0.6
" In all cases, chloroprocaine was chosen because of preexisting or associated conditions that might increase the risk of bupivacaine toxicity, such as hepatic resection, repeated dosing in a neonate, or the need for higher concentrations of local anesthetic to achieve adequate surgical conditions."( Chloroprocaine for epidural anesthesia in infants and children.
O'Dell, N; Tobias, JD, 1995
)
2.09
" The optimized methods show good linearity, precision (RSD < 2%) and accuracy (bias < 2% for dosage forms)."( Validation of high-performance liquid chromatographic methods on two silica base-deactivated reversed phases for the determination of chloroprocaine and bupivacaine.
Brun, F; Veuthey, JL, 1996
)
0.5
" We compared spinal versus systemic dose-response to L-NAME, and examined effects of intrathecal arginine on tachyphylaxis."( Evidence that spinal segmental nitric oxide mediates tachyphylaxis to peripheral local anesthetic nerve block.
Berde, CB; DiCanzio, J; Sholas, MG; Wang, C; Wilder, RT; Zurakowski, D, 2001
)
0.31
" We examined the safety, dose-response characteristics, and effects of epinephrine with spinal 2-CP."( Spinal 2-chloroprocaine: a dose-ranging study and the effect of added epinephrine.
Kopacz, DJ; McDonald, SB; Smith, KN, 2004
)
0.74
"We evaluated the dose-response relationship of 2-chloroprocaine for lower limb outpatient procedure in 45 ASA physical status I-II outpatients undergoing elective lower limb surgery under spinal anesthesia, with 30 mg (group Chlor-30, n = 15), 40 mg (group Chlor-40, n = 15), or 50 mg (group Chlor-50, n = 15) of 1% preservative free 2-chloroprocaine."( Intrathecal 2-chloroprocaine for lower limb outpatient surgery: a prospective, randomized, double-blind, clinical evaluation.
Benassi, C; Berti, M; Casati, A; Danelli, G; Fanelli, A; Fanelli, G; Fioro, A; Petronella, G, 2006
)
0.95
" Duration of epidural infusion did not influence dosing requirement, suggesting the absence of drug tachyphylaxis."( Evaluation of prolonged epidural chloroprocaine for postoperative analgesia in infants.
Bielsky, AR; Murphy, ME; Reiter, PD; Ross, EL, 2015
)
0.7
" The aim of this trial was to determine the optimal dosage of chloroprocaine for this indication."( Chloroprocaine 10 mg/ml for low-dose spinal anaesthesia in perianal surgery - a randomised dose finding study.
Bussen, D; Gebhardt, V; Mueller-Hansen, L; Schmittner, MD; Schwarz, A; Weiss, C, 2017
)
2.14
" Dosing regimens are presented and the applications of 2-chloroprocaine in this population are discussed."( Chloroprocaine for epidural anesthesia in infants and children.
Tobias, JD; Veneziano, G, 2017
)
2.14
" Current results cannot be extrapolated to repeated dosing or prolonged infusion."( Evaluation of neurotoxicity and long-term function and behavior following intrathecal 1 % 2-chloroprocaine in juvenile rats.
Eddinger, K; Grafe, MR; Malkmus, S; Powell, SB; Roberts, AJ; Shubayev, VI; Steinauer, J; Walker, SM; Yaksh, TL, 2022
)
0.94
" Therefore, our study suggests that intraperitoneal chloroprocaine, in a dosage ≤1200 mg, administered after fetal extraction, is well tolerated during cesarean delivery."( Pharmacokinetics and Tolerability of Intraperitoneal Chloroprocaine After Fetal Extraction in Women Undergoing Cesarean Delivery.
Bleyle, LA; Brookfield, K; Koop, D; Togioka, BM; Treggiari, MM; Yanez, ND; Zarnegarnia, Y, 2022
)
1.22
" Subjects were randomized to initial dosing to a T4 dermatome surgical anesthetic level with either 3% CP or 2% lidocaine with 1:200,000 epinephrine and sodium bicarbonate (LEB)."( Postcesarean Analgesia With Epidural Morphine After Epidural 2-Chloroprocaine: A Randomized Noninferiority Trial.
Lee, LO; Lu, M; Ramirez-Chapman, AL; Suresh, MS; White, DL; Zhang, X, 2023
)
1.15
"While designed as an exploratory study, initial epidural dosing with 3% CP and beginning subsequent redosing with LEB within 30 minutes of the initial CP bolus provided noninferior postcesarean analgesia with epidural morphine compared to initial epidural dosing and redosing with LEB."( Postcesarean Analgesia With Epidural Morphine After Epidural 2-Chloroprocaine: A Randomized Noninferiority Trial.
Lee, LO; Lu, M; Ramirez-Chapman, AL; Suresh, MS; White, DL; Zhang, X, 2023
)
1.15
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Roles (3)

RoleDescription
local anaestheticAny member of a group of drugs that reversibly inhibit the propagation of signals along nerves. Wide variations in potency, stability, toxicity, water-solubility and duration of action determine the route used for administration, e.g. topical, intravenous, epidural or spinal block.
peripheral nervous system drugA drug that acts principally at one or more sites within the peripheral neuroeffector systems, the autonomic system, and motor nerve-skeletal system.
central nervous system depressantA loosely defined group of drugs that tend to reduce the activity of the central nervous system.
[role information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Drug Classes (2)

ClassDescription
benzoate esterEsters of benzoic acid or substituted benzoic acids.
monochlorobenzenesAny member of the class of chlorobenzenes containing a mono- or poly-substituted benzene ring in which only one substituent is chlorine.
[compound class information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Pathways (1)

PathwayProteinsCompounds
Chloroprocaine Action Pathway3111

Protein Targets (1)

Inhibition Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Bile salt export pumpHomo sapiens (human)IC50 (µMol)1,000.00000.11007.190310.0000AID1449628
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Biological Processes (22)

Processvia Protein(s)Taxonomy
fatty acid metabolic processBile salt export pumpHomo sapiens (human)
bile acid biosynthetic processBile salt export pumpHomo sapiens (human)
xenobiotic metabolic processBile salt export pumpHomo sapiens (human)
xenobiotic transmembrane transportBile salt export pumpHomo sapiens (human)
response to oxidative stressBile salt export pumpHomo sapiens (human)
bile acid metabolic processBile salt export pumpHomo sapiens (human)
response to organic cyclic compoundBile salt export pumpHomo sapiens (human)
bile acid and bile salt transportBile salt export pumpHomo sapiens (human)
canalicular bile acid transportBile salt export pumpHomo sapiens (human)
protein ubiquitinationBile salt export pumpHomo sapiens (human)
regulation of fatty acid beta-oxidationBile salt export pumpHomo sapiens (human)
carbohydrate transmembrane transportBile salt export pumpHomo sapiens (human)
bile acid signaling pathwayBile salt export pumpHomo sapiens (human)
cholesterol homeostasisBile salt export pumpHomo sapiens (human)
response to estrogenBile salt export pumpHomo sapiens (human)
response to ethanolBile salt export pumpHomo sapiens (human)
xenobiotic export from cellBile salt export pumpHomo sapiens (human)
lipid homeostasisBile salt export pumpHomo sapiens (human)
phospholipid homeostasisBile salt export pumpHomo sapiens (human)
positive regulation of bile acid secretionBile salt export pumpHomo sapiens (human)
regulation of bile acid metabolic processBile salt export pumpHomo sapiens (human)
transmembrane transportBile salt export pumpHomo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Molecular Functions (8)

Processvia Protein(s)Taxonomy
protein bindingBile salt export pumpHomo sapiens (human)
ATP bindingBile salt export pumpHomo sapiens (human)
ABC-type xenobiotic transporter activityBile salt export pumpHomo sapiens (human)
bile acid transmembrane transporter activityBile salt export pumpHomo sapiens (human)
canalicular bile acid transmembrane transporter activityBile salt export pumpHomo sapiens (human)
carbohydrate transmembrane transporter activityBile salt export pumpHomo sapiens (human)
ABC-type bile acid transporter activityBile salt export pumpHomo sapiens (human)
ATP hydrolysis activityBile salt export pumpHomo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Ceullar Components (12)

Processvia Protein(s)Taxonomy
basolateral plasma membraneBile salt export pumpHomo sapiens (human)
Golgi membraneBile salt export pumpHomo sapiens (human)
endosomeBile salt export pumpHomo sapiens (human)
plasma membraneBile salt export pumpHomo sapiens (human)
cell surfaceBile salt export pumpHomo sapiens (human)
apical plasma membraneBile salt export pumpHomo sapiens (human)
intercellular canaliculusBile salt export pumpHomo sapiens (human)
intracellular canaliculusBile salt export pumpHomo sapiens (human)
recycling endosomeBile salt export pumpHomo sapiens (human)
recycling endosome membraneBile salt export pumpHomo sapiens (human)
extracellular exosomeBile salt export pumpHomo sapiens (human)
membraneBile salt export pumpHomo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Bioassays (16)

Assay IDTitleYearJournalArticle
AID625288Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for jaundice2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625283Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for elevated liver function tests2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625285Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatic necrosis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625286Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatitis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625287Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatomegaly2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625281Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cholelithiasis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625290Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver fatty2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625280Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cholecystitis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625291Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver function tests abnormal2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID781330pKa (acid-base dissociation constant) as determined by potentiometric titration2014Pharmaceutical research, Apr, Volume: 31, Issue:4
Comparison of the accuracy of experimental and predicted pKa values of basic and acidic compounds.
AID625292Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) combined score2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625289Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver disease2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1449628Inhibition of human BSEP expressed in baculovirus transfected fall armyworm Sf21 cell membranes vesicles assessed as reduction in ATP-dependent [3H]-taurocholate transport into vesicles incubated for 5 mins by Topcount based rapid filtration method2012Drug metabolism and disposition: the biological fate of chemicals, Dec, Volume: 40, Issue:12
Mitigating the inhibition of human bile salt export pump by drugs: opportunities provided by physicochemical property modulation, in silico modeling, and structural modification.
AID625282Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cirrhosis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625279Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for bilirubinemia2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625284Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatic failure2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (342)

TimeframeStudies, This Drug (%)All Drugs %
pre-1990152 (44.44)18.7374
1990's64 (18.71)18.2507
2000's46 (13.45)29.6817
2010's48 (14.04)24.3611
2020's32 (9.36)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 53.37

According to the monthly volume, diversity, and competition of internet searches for this compound, as well the volume and growth of publications, there is estimated to be very strong demand-to-supply ratio for research on this compound.

MetricThis Compound (vs All)
Research Demand Index53.37 (24.57)
Research Supply Index6.19 (2.92)
Research Growth Index4.57 (4.65)
Search Engine Demand Index86.25 (26.88)
Search Engine Supply Index2.00 (0.95)

This Compound (53.37)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials101 (26.10%)5.53%
Reviews19 (4.91%)6.00%
Case Studies34 (8.79%)4.05%
Observational4 (1.03%)0.25%
Other229 (59.17%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (35)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Post-cesarean Analgesia With Epidural Morphine Following Epidural 2-chloroprocaine [NCT04369950]Phase 444 participants (Actual)Interventional2020-05-11Completed
Estimation of Effective Dose 95 (ED95) of Intrathecal Isobaric 2-chloroprocaine (2-CP) Based on the Height (cm) of a Patient Undergoing Ambulatory Knee Arthroscopy : Dose-finding Study Based on the Continual Reassessment Method (CRM) [NCT03882489]120 participants (Actual)Observational2019-04-11Completed
A Randomized Controlled Clinical Trial of Intrathecal Chloroprocaine vs. Bupivacaine for Cervical Cerclage [NCT03305575]Phase 410 participants (Actual)Interventional2017-10-13Completed
A Randomized, Double-blind Study Comparing 3% Chloroprocaine Versus 2 % Lidocaine/ Epinephrine/ Bicarbonate/ Fentanyl for Epidural Anesthesia in Elective Cesarean Delivery [NCT03414359]Early Phase 170 participants (Actual)Interventional2018-02-15Completed
An Evaluation of Intraabdominal Chloroprocaine During Cesarean Delivery and Its Effect on Postoperative Pain and Nausea; a Randomized Controlled Trial & Pharmacokinetic-pharmacodynamics (PKPD) Analysis. [NCT03260972]Phase 30 participants (Actual)Interventional2021-06-30Withdrawn(stopped due to Withdrawn by IRB)
Comparing 1% Spinal Chloroprocaine to Low-dose Bupivacaine Using the Epidural Volume Extension Technique for Post-Partum Tubal Ligation [NCT03993314]Phase 215 participants (Actual)Interventional2019-08-13Terminated(stopped due to Lack of recruitment due to COVID-19 pandemic; chloroprocaine shortage)
Comparision of the Use in Marcaine and Chloroprocaine in Rachianesthesia for the Surgical Correction of Inguinal Hernia. [NCT02049255]Phase 450 participants (Actual)Interventional2013-11-30Completed
A Prospective, Observer-blind, Randomized Clinical Trial to Investigate and Compare the Clinical Efficacy of Chloroprocaine 3% Gel and Oxybuprocaine 0.4% Eye Drops Anesthesia for Clinical Practice in Pediatric Population [NCT05926258]Phase 374 participants (Anticipated)Interventional2024-02-29Not yet recruiting
Determination of the Minimum Local Analgesic Dose of Spinal Chloroprocaine in Labour. [NCT01909089]Phase 440 participants (Actual)Interventional2013-10-17Completed
Low Epidural Anesthesia With Chloroprocaine Versus Lidocaine: a Prospective, Randomized, Double-blinded Multi-centre Clinical Trial in China [NCT02287870]Phase 4120 participants (Actual)Interventional2008-01-31Completed
Comparison of Epidural Chloroprocaine 3% and Ropivacaine 0.75% for Unplanned Caesarean Section in Labouring Women Who Have an Epidural Catheter in Situ [NCT02919072]Phase 316 participants (Actual)Interventional2016-10-31Terminated(stopped due to The doctors involved in the study did not enroll any patients)
Intrathecal 60mg Prilocaine, Hyperbaric 40mg 9-chloroprocaine and 10.5mg Bupivacaine Each With Added Sufentanil (2µg) for Elective Ambulatory Umbilical and Unilateral Inguinal Herniorrhaphy [NCT02813382]101 participants (Actual)Observational2015-08-31Completed
The Effects of Low Viscosity Chloroprocaine Ophthalmic Gel 3% on the Bactericidal Action of Povidone-Iodine: A Comparison vs Tetracaine 0.5% Solution. [NCT05934253]Phase 460 participants (Anticipated)Interventional2023-07-15Recruiting
[NCT02207855]21 participants (Actual)Observational2014-06-30Completed
Chloroprocaine Lavage to Improve Outcomes Related to Operative Cesarean Delivery [NCT03760718]Early Phase 115 participants (Anticipated)Interventional2019-09-30Active, not recruiting
A Comparison Study to Facilitate Earlier Discharge: Spinal Versus General Anesthesia for Outpatient Knee Surgeries, a Randomized Controlled Study [NCT03365752]Phase 239 participants (Actual)Interventional2018-06-24Terminated(stopped due to Study halted due to COVID-19 pandemic and terminated early per request of principal investigator as Chloroprocaine use in spinal procedures has become incorporated as standard of care at HSS.)
Double Blinded Randomized Control Trial Comparing the Onset and Duration of Ultrasound Guided Supraclavicular Nerve Blocks Using Ropivacaine Versus Ropivacaine-Chloroprocaine Mixture [NCT01719237]Phase 460 participants (Actual)Interventional2009-08-31Completed
Determining the ED90 for Intrathecal 3% Chloroprocaine for Elective Cervical Cerclage Surgery [NCT03805438]Phase 447 participants (Actual)Interventional2019-02-07Completed
Spinal Anesthesia With Bupivacaine or 2-chloroprocaine for Outpatient Elective Surgery: a Prospective, Randomized, Double-blind Comparison. [NCT00845962]106 participants (Actual)Interventional2009-02-28Completed
Determination of the Minimum Local Anesthetic Dose (MLAD) of Spinal Chloroprocaine for Inguinal Herniorrhaphy in Ambulatory Surgery [NCT03805503]Phase 412 participants (Actual)Interventional2015-09-16Completed
Chloroprocaine Versus Bupivacaine Spinal Anesthesia for Cervical Cerclage [NCT02862912]Phase 443 participants (Actual)Interventional2016-11-08Completed
The Maternal CLIMB Trial: Chloroprocaine to Reduce the Impact of Motor Block on Patient Recovery After Short Obstetric Surgery [NCT03967288]Phase 427 participants (Actual)Interventional2019-10-24Suspended(stopped due to Four patients required conversion to GETA (2 in each study arm))
Decision Support for Intraoperative Low Blood Pressure [NCT02726620]22,435 participants (Actual)Interventional2017-01-05Completed
Spinal Anaesthesia With Chloroprocaine HCl 1% for Elective Lower Limb Procedures of Short Duration: a Prospective, Randomised, Observer-blind Study in Adult Patients [NCT02481505]Phase 245 participants (Actual)Interventional2015-06-30Completed
Dose-finding Study of Intrathecal Paracetamol Administered Immediately Before Spinal Anaesthesia With Chloroprocaine HCl 1% for Elective Knee Procedures of Short Duration [NCT03428230]Phase 260 participants (Actual)Interventional2018-08-06Completed
Comparison of Hyperbaric Prilocaine With Chloroprocaine for Intrathecal Anaesthesia in Day Case Knee Arthroscopy [NCT03038958]Phase 480 participants (Actual)Interventional2016-04-30Completed
Comparison of 1% Chloroprocaine vs. Hyperbaric Bupivacaine Spinals in Patients Undergoing Hemorrhoidectomies in an Ambulatory Surgery Center: A Double-Blind Randomized Controlled Pilot Trial. [NCT03324984]Phase 2110 participants (Actual)Interventional2019-09-06Completed
A Prospective, Observer-masked, Randomized Clinical Trial to Investigate and Compare the Clinical Efficacy of Chloroprocaine 3% Gel and Tetracaine 0.5% Eye Drop as Topical Anestheticsin Phacoemulsification. [NCT04685538]Phase 3338 participants (Actual)Interventional2020-09-09Completed
Observational Prospective Study on 2-chloroprocaine Hydrochloride 1% Safety in Intrathecal Anesthesia [NCT02067806]394 participants (Actual)Observational [Patient Registry]2013-11-30Completed
A Prospective, Randomised, Non-inferiority Study of Chloroprocaine 2% and the Active Control Ropivacaine 0.75% (AstraZeneca) in Ultrasound-guided Axillary Nerve Block for Short-duration Distal Upper Limb Surgery [NCT02385097]Phase 3211 participants (Actual)Interventional2015-04-30Completed
Evaluation of the Comparative Analgesic Value of Adductor Canal Block Versus Femoral Block Following Total Knee Arthroplasty [NCT03395990]16 participants (Actual)Interventional2016-03-27Completed
Can the Choice of the Local Anesthetic Have an Impact on Ambulatory Surgery Perioperative Costs? Chloroprocaine for Popliteal Block in Outpatient Foot Surgery [NCT02406703]100 participants (Actual)Observational2014-01-31Completed
Perioperative Outcomes in Patients Received Spinal Chloroprocaine for Hip or Knee Arthroplasty [NCT05365074]65 participants (Actual)Observational2020-01-01Completed
Influence of Spinal or Intravenous Dexmedetomidine on Spinal Anesthesia With Chloroprocaine and Bladder Function in Day-case Surgery. A Double Blind Randomized Study. [NCT02282319]Phase 4150 participants (Anticipated)Interventional2014-10-31Completed
Randomized, Multi-center, Double-blind, Two-armed, Parallel Active Groups, Prospective Trial, to Evaluate, in Pediatric Population, the Efficacy and Safety of Chloroprocaine 1% and 2% for Peripheral Nerve Block. [NCT03918798]Phase 2174 participants (Anticipated)Interventional2019-02-14Recruiting
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT01719237 (2) [back to overview]Duration of Analgesia
NCT01719237 (2) [back to overview]Onset of Surgical Anesthesia
NCT02067806 (3) [back to overview]Number of Participants With Symptoms in Follow-Up Questionnaire at 7 Days
NCT02067806 (3) [back to overview]Number of Participants With Symptoms in Follow-Up Questionnaire at 24 Hours
NCT02067806 (3) [back to overview]Number of Participants With Adverse Events
NCT02385097 (14) [back to overview]Neurological Symptoms
NCT02385097 (14) [back to overview]Time to Onset of Sensory Block (Corresponding to Readiness for Surgery)
NCT02385097 (14) [back to overview]Time to Onset of Motor Block
NCT02385097 (14) [back to overview]Heart Rate
NCT02385097 (14) [back to overview]Time to Eligibility for Home Discharge
NCT02385097 (14) [back to overview]Percentage of Participants With Successful Block for Distal Upper Limb Surgeries
NCT02385097 (14) [back to overview]Partecipants Received Rescue Anaesthesia or Rescue Analgesia
NCT02385097 (14) [back to overview]Number of Subjects Who Received Post-operative Analgesia
NCT02385097 (14) [back to overview]Number of Participants With Normal Electrocardiogram (ECG) Parameters
NCT02385097 (14) [back to overview]SpO2
NCT02385097 (14) [back to overview]Number of Participants With Treatment-emergent Adverse Events (TEAEs)
NCT02385097 (14) [back to overview]Blood Pressure
NCT02385097 (14) [back to overview]Time to Regression of Sensory Block
NCT02385097 (14) [back to overview]Time to Regression of Motor Block
NCT02481505 (24) [back to overview]Blood Pressure
NCT02481505 (24) [back to overview]Transient Neurological Symptoms (TNS)
NCT02481505 (24) [back to overview]SpO2
NCT02481505 (24) [back to overview]Sensory Block Metameric Level
NCT02481505 (24) [back to overview]Pain Assessment at the Site of Injection and at the Site of Surgery
NCT02481505 (24) [back to overview]Maximum Level of Sensory Block
NCT02481505 (24) [back to overview]Heart Rate
NCT02481505 (24) [back to overview]Concentration of 2-chloro-4-aminobenzoic Acid (CABA) in Plasma
NCT02481505 (24) [back to overview]Time to First Spontaneous Urine Voiding
NCT02481505 (24) [back to overview]Time to First Post-operative Analgesia
NCT02481505 (24) [back to overview]Time to Eligibility for Home Discharge
NCT02481505 (24) [back to overview]Time to Administration of Rescue Anaesthesia or Rescue Analgesia
NCT02481505 (24) [back to overview]Excretion of 2-chloro-4-aminobenzoic Acid (CABA) in Urine
NCT02481505 (24) [back to overview]Time to Resolution of Sensory Block to S1(Min)
NCT02481505 (24) [back to overview]Time to Resolution of Motor Block
NCT02481505 (24) [back to overview]Time to Regression of Spinal Block
NCT02481505 (24) [back to overview]Time to Unassisted Ambulation
NCT02481505 (24) [back to overview]Treatment-emergent Adverse Events (TEAEs)
NCT02481505 (24) [back to overview]Time to Regression of Two Dermatomers With Respect to the Maximum Level of Sensory Block
NCT02481505 (24) [back to overview]Time to Regression of Spinal Block
NCT02481505 (24) [back to overview]Time to Readiness for Surgery
NCT02481505 (24) [back to overview]Time to Onset of Sensory Block (Corresponding to Readiness for Surgery)
NCT02481505 (24) [back to overview]Time to Onset of Motor Block
NCT02481505 (24) [back to overview]Time to Maximum Level of Sensory Block
NCT02726620 (43) [back to overview]Incidence of a MAP < 50 mmHg for > 10 Minutes
NCT02726620 (43) [back to overview]30-day Mortality
NCT02726620 (43) [back to overview]Inhaled Anesthetic Drug Use During Intraoperative Hypotension: MAP < 50 mmHg
NCT02726620 (43) [back to overview]Inhaled Anesthetic Drug Use During Intraoperative Hypotension: MAP < 55 mmHg
NCT02726620 (43) [back to overview]Usage Frequency of Cardiovascular Drugs: Phenylephrine
NCT02726620 (43) [back to overview]Inhaled Anesthetic Drug Use During Intraoperative Hypotension: MAP < 60 mmHg
NCT02726620 (43) [back to overview]Time to Discharge Readiness at the Postanesthesia Care Unit (PACU)
NCT02726620 (43) [back to overview]Inhaled Anesthetic Drug Use During Intraoperative Hypotension: MAP < 65 mmHg
NCT02726620 (43) [back to overview]Depth and Duration of Intraoperative Hypotension - Threshold MAP 75 mmHg
NCT02726620 (43) [back to overview]Estimated Intraoperative Blood Loss
NCT02726620 (43) [back to overview]In-hospital Mortality
NCT02726620 (43) [back to overview]Incidence of a MAP < 50 mmHg
NCT02726620 (43) [back to overview]Incidence of a MAP < 55 mmHg for > 20 Minutes
NCT02726620 (43) [back to overview]Incidence of a MAP < 50 mmHg for > 20 Minutes
NCT02726620 (43) [back to overview]Incidence of a MAP < 55 mmHg
NCT02726620 (43) [back to overview]Incidence of a MAP < 55 mmHg for > 10 Minutes
NCT02726620 (43) [back to overview]Depth and Duration of Intraoperative Hypotension - Threshold MAP 65 mmHg
NCT02726620 (43) [back to overview]Incidence of a MAP < 60 mmHg
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 for > 20 Minutes
NCT02726620 (43) [back to overview]Intraoperative Administration of Intravenous Fluids
NCT02726620 (43) [back to overview]Intravenous Anesthetic Drug Use During Intraoperative Hypotension: MAP < 50 mmHg
NCT02726620 (43) [back to overview]Intravenous Anesthetic Drug Use During Intraoperative Hypotension: MAP < 55 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 < 65 mmHg
NCT02726620 (43) [back to overview]Postoperative Rise in Creatinine Levels
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]Depth and Duration of Intraoperative Hypotension - Threshold MAP 55 mmHg
NCT02726620 (43) [back to overview]Timing of Cardiovascular Drugs for MAP < 60 mmHg
NCT02726620 (43) [back to overview]Timing of Cardiovascular Drugs for MAP < 65 mmHg
NCT02726620 (43) [back to overview]Usage Frequency of Cardiovascular Drugs: Ephedrine
NCT02726620 (43) [back to overview]Usage Frequency of Cardiovascular Drugs: Ephinephrine
NCT02726620 (43) [back to overview]Usage Frequency of Cardiovascular Drugs: Glycopyrrolate
NCT02726620 (43) [back to overview]Usage Frequency of Cardiovascular Drugs: Norepinephrine
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 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: Glycopyrrolate
NCT02726620 (43) [back to overview]Depth and Duration of Intraoperative Hypotension - Threshold MAP 60 mmHg
NCT02726620 (43) [back to overview]Average Use of Cardiovascular Drugs: Epinephrine
NCT02726620 (43) [back to overview]Average Use of Cardiovascular Drugs: Ephedrine
NCT02862912 (3) [back to overview]Time to Void
NCT02862912 (3) [back to overview]Time to Resolution of Motor Block
NCT02862912 (3) [back to overview]Time to Ambulate
NCT02919072 (3) [back to overview]Quality of the Block
NCT02919072 (3) [back to overview]Time to the Onset of Anaesthesia
NCT02919072 (3) [back to overview]Time From T0 to Loss Light Touch Sensation
NCT03305575 (4) [back to overview]Duration of Sensory Block
NCT03305575 (4) [back to overview]Time to Ambulation
NCT03305575 (4) [back to overview]Time to Micturation
NCT03305575 (4) [back to overview]Duration of Motor Block
NCT03365752 (1) [back to overview]Readiness for Discharge
NCT03395990 (1) [back to overview]Pain Intensity as Measured by 11-point Verbal Numeric Rating Scale (NRS-11) for Pain.
NCT03414359 (2) [back to overview]The Onset Time to Surgical Anesthesia
NCT03414359 (2) [back to overview]Secondary Outcome: Number of Participants With Requirement for Intraoperative Analgesia Supplementation
NCT03428230 (21) [back to overview]Time to Regression of Spinal Block
NCT03428230 (21) [back to overview]Time to Sensory Block
NCT03428230 (21) [back to overview]Total Number of Partecipants Receiving Analgesic 1
NCT03428230 (21) [back to overview]Total Number of Partecipants Receiving Analgesic 2
NCT03428230 (21) [back to overview]Pain at Rest AUCt1-t2
NCT03428230 (21) [back to overview]Percentage of Patients Requiring Analgesia From Surgery End Until Eligibility for Discharge
NCT03428230 (21) [back to overview]Pain Intensity at Rest Evaluated Using a 0-100 mm VAS
NCT03428230 (21) [back to overview]Percentage of Patients Requiring Supplementary Analgesia, Other Than the Planned Level 1 or 2 Analgesia
NCT03428230 (21) [back to overview]Number of Participants With Neurological Complications Including TNS
NCT03428230 (21) [back to overview]Pain at Rest AUClast
NCT03428230 (21) [back to overview]Partecipants Received Level 2 Analgesia
NCT03428230 (21) [back to overview]Partecipants to Received Level 1 Analgesia
NCT03428230 (21) [back to overview]Time to Eligibility for Discharge
NCT03428230 (21) [back to overview]Percentage of Patients Requiring Analgesia in the First 2 h After Surgery End
NCT03428230 (21) [back to overview]Percentage of Patients Requiring Analgesia in the First 4 h After Surgery End
NCT03428230 (21) [back to overview]Percentage of Patients Requiring Level 1 Analgesia From Surgery End Until Eligibility for Discharge
NCT03428230 (21) [back to overview]Percentage of Patients Requiring Level 2 Analgesia From Surgery End Until Eligibility for Discharge
NCT03428230 (21) [back to overview]Percentage of Patients Requiring Rescue Anaesthesia
NCT03428230 (21) [back to overview]Time to Ambulation
NCT03428230 (21) [back to overview]Time to First Urine
NCT03428230 (21) [back to overview]Time to Onset of Spinal Block (i.e. Time to Readiness for Surgery)
NCT03805438 (15) [back to overview]Time to Resolution of Motor Block at End of the Cerclage Placement (Measured in the PACU).
NCT03805438 (15) [back to overview]The Dose of Intrathecal (IT) Chloroprocaine That Provides Effective Anesthesia in 90% of Patients Undergoing Elective Cerclage Placement (Intraoperative Analgesic Supplementation Not Required).
NCT03805438 (15) [back to overview]Time From Spinal Block to Ambulation
NCT03805438 (15) [back to overview]Time From Spinal Block to Micturition
NCT03805438 (15) [back to overview]Time to Complete Sensory Regression
NCT03805438 (15) [back to overview]Time to Hospital Discharge as Measured as the Time Difference Between Local Anesthetic Injection and Discharge Time as Recorded in the Medical Notes
NCT03805438 (15) [back to overview]Time to Readiness for PACU Discharge (Pre-defined Nursing Criteria)
NCT03805438 (15) [back to overview]Time to Resolution of Motor Block (Bromage Score of 5)
NCT03805438 (15) [back to overview]Number of Patients Who Were Given Vasopressor Phenylephrine (and Ephedrine) BP Drops Greater Than 15% Below Baseline or < 100mg Hg Systolic.
NCT03805438 (15) [back to overview]Overall Patient Satisfaction at Time of PACU Discharge.
NCT03805438 (15) [back to overview]The Average Dose of Phenylephrine Given to Those Patients Whose BP Dropped Greater Than 15% Below Baseline or < 100mg Hg Systolic.
NCT03805438 (15) [back to overview]Number of Participants With Observed Vomiting. (Observed Yes or no).
NCT03805438 (15) [back to overview]Number of Participants Who Reported Nausea (Self-reported by Patient, Yes or no).
NCT03805438 (15) [back to overview]Number of Participants Reporting Itching. (Self-reported by Patient, Yes or no).
NCT03805438 (15) [back to overview]Maximum Pain Numerical Pain Rating Scale (NPRS) During Surgery (as Reported by Patient, Scored From 0-10 in the PACU).
NCT03993314 (2) [back to overview]Time to PACU Discharge
NCT03993314 (2) [back to overview]Level of Numbness
NCT04369950 (8) [back to overview]Total Amount of Opioid Used
NCT04369950 (8) [back to overview]Pain as Measured by a 11 Point Verbal 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]Number of Participants Who Had Mild, Moderate or Severe Nausea as Measured by a 3 Point Scale
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]Time Until First Opioid Request
NCT04685538 (11) [back to overview]Corneal Thickness
NCT04685538 (11) [back to overview]Changes in Ocular Symptoms
NCT04685538 (11) [back to overview]Best Far Corrected Visual Acuity
NCT04685538 (11) [back to overview]Surgeon Satisfaction
NCT04685538 (11) [back to overview]Objective Ocular Signs
NCT04685538 (11) [back to overview]Patient Global Satisfaction
NCT04685538 (11) [back to overview]Number of Participants in Each Treatment Group With a Successful Surface Anesthesia
NCT04685538 (11) [back to overview]Intra-ocular Pressure
NCT04685538 (11) [back to overview]Fluoresceine
NCT04685538 (11) [back to overview]Endothelial Cell Counts
NCT04685538 (11) [back to overview]Number of Participants With Abnormalities of the Retina, Macula, or Optic Nerve by Fundoscopy

Duration of Analgesia

Time interval between the end of local anestehtic injection and the patient's first report of pain in the surgical site after surgery (NCT01719237)
Timeframe: 72 hours

Interventionminutes (Median)
Ropivacaine and Cholroprocaine Mixture566
Ropivacaine Only718

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Onset of Surgical Anesthesia

Onset of surgical anesthesia is defined as the time after injection of local anesthetic to the time where no sensation of pinprick in the ulnar, median, radial and musculocutaneous nerves (NCT01719237)
Timeframe: 45 minutes

,
Interventionminutes (Median)
Ulnar-SensoryMedian-SensoryRadial-SensoryMusculocutaneous-Sensory
Ropivacaine and Cholroprocaine Mixture16969
Ropivacaine Only22161010

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Number of Participants With Symptoms in Follow-Up Questionnaire at 7 Days

the follow-up questionnaires are foreseen, at 7 days after time of spinal injection (Tsp), to gather all possible neurological adverse events. About 7 days after surgery (indicated as Tsp),Investigator or a deputy will question patients about neurological symptoms and pain not associated to the operation area on the basis of the follow-up questionnaires and giving a score between 0 to 10 to the pain intensity. All other adverse events will also be assessed. (NCT02067806)
Timeframe: 7 days

Interventionnumber of patients (Number)
fatiguenausea/vomitingdizzinessurin/defec problems
Chloroprocaine 1%3112

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Number of Participants With Symptoms in Follow-Up Questionnaire at 24 Hours

the follow-up questionnaires are foreseen, at 24 h after time of spinal injection (Tsp), to gather all possible neurological adverse events. About 24 h after surgery (indicated as Tsp),Investigator or a deputy will question patients about neurological symptoms and pain not associated to the operation area on the basis of the follow-up questionnaires and giving a score between 0 to 10 to the pain intensity. All other adverse events will also be assessed. (NCT02067806)
Timeframe: 24 hours

Interventionnumber of patients (Number)
fatiguenausea/vomitingdizzinessurin/defec problems
Chloroprocaine 1%4311

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Number of Participants With Adverse Events

Number of Participants with neurological adverse events, with particular attention to Transient Neurological Symptoms (TNS) and Cauda Equina Syndrome(CES). (NCT02067806)
Timeframe: assessed at 24h and 7(-1/+2) days after surgery, total reported

Interventionparticipants (Number)
24 hours7 days
Chloroprocaine 1%95

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Neurological Symptoms

Number of patients with Neurological Symptoms (e.g. paraesthesia, motor function problems and pain at the injection site) (NCT02385097)
Timeframe: from surgery day to day 6 +/- 1 after surgery

,
InterventionParticipants (Count of Participants)
burning : dischargeburning : day 7tingling : dischargetingling : day 7Pins and needles sensation : dischargePins and needles sensation : day 7Pricking : dischargePricking : day 7aching : dischargeaching : day 7numbness : dischargenumbness : day 7hypoesthesia : dischargehypoesthesia : day 7Pain surgery site : dischargePain surgery site : day 7diffuse hair loss : dischargediffuse hair loss : day 7headache : dischargeheadache : day 7itching : dischargeitching : day 7
Chloroprocaine HCl 2% (20 mg/mL)86851280104225500000200
Ropivacaine 0.75% (7.5 mg/mL)1425650506327314510010001

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Time to Onset of Sensory Block (Corresponding to Readiness for Surgery)

Time period from completion of the final perineural injection (time 0 h) to achievement of sensory block in the 4 nerve territories (NCT02385097)
Timeframe: Up to 1 h after last perineural injection

Interventionminutes (Median)
Chloroprocaine HCl 2% (20 mg/mL)10
Ropivacaine 0.75% (7.5 mg/mL)15

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Time to Onset of Motor Block

Time period from completion of the final perineural injection (time 0 h) to achievement of motor block (NCT02385097)
Timeframe: Up to 1 h after last perineural injection

Interventionminutes (Median)
Chloroprocaine HCl 2% (20 mg/mL)10
Ropivacaine 0.75% (7.5 mg/mL)10

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Heart Rate

"The following normal ranges Heart Rate parameters will be used:~50-90 beats/min" (NCT02385097)
Timeframe: from surgery day to 24 hrs post surgery

,
Interventionbeats/minutes (Mean)
screeningbaselinedischarge
Chloroprocaine HCl 2% (20 mg/mL)7372.571.5
Ropivacaine 0.75% (7.5 mg/mL)73.671.673

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Time to Eligibility for Home Discharge

Time from completion of the final perineural injection (time 0 h) to the time when the criteria for discharge are met, even if, according to the hospital procedures, the patient is discharged from the hospital at a later time (NCT02385097)
Timeframe: from surgery day to 24h post surgery

Interventionminutes (Median)
Chloroprocaine HCl 2% (20 mg/mL)161
Ropivacaine 0.75% (7.5 mg/mL)355.5

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Percentage of Participants With Successful Block for Distal Upper Limb Surgeries

Percentage of patients with a successful block for distal upper limb surgeries, without any supplementation in the first 45 min, calculated from the time of readiness for surgery (complete sensory block). (NCT02385097)
Timeframe: 45 min from the time of readiness of surgery

InterventionParticipants (Count of Participants)
Chloroprocaine HCl 2% (20 mg/mL)96
Ropivacaine 0.75% (7.5 mg/mL)97

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Partecipants Received Rescue Anaesthesia or Rescue Analgesia

partecipants received rescue anaesthesia or rescue analgesia from completion of the final perineural injection (time 0 hour) to administration of first rescue anaesthesia or analgesia (supplementation) (NCT02385097)
Timeframe: 45 min from the time of readiness of surgery

InterventionParticipants (Count of Participants)
Chloroprocaine HCl 2% (20 mg/mL)9
Ropivacaine 0.75% (7.5 mg/mL)7

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Number of Subjects Who Received Post-operative Analgesia

Number of subjects who received the first post-operative analgesia (NCT02385097)
Timeframe: From surgery day to 24 hrs post surgery

InterventionParticipants (Count of Participants)
Chloroprocaine HCl 2% (20 mg/mL)49
Ropivacaine 0.75% (7.5 mg/mL)46

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Number of Participants With Normal Electrocardiogram (ECG) Parameters

"Number of Participants with Normal Electrocardiogram (ECG) Parameters. The following normal ranges ECG parameters will be used:~Heart Rate: 50-90 beats/min PR Interval: 100-220 msec QRS Duration: ≤ 120 msec QT Interval: ≤ 500 msec" (NCT02385097)
Timeframe: from surgery day to 24 hrs post surgery

InterventionParticipants (Count of Participants)
Chloroprocaine HCl 2% (20 mg/mL)105
Ropivacaine 0.75% (7.5 mg/mL)104

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SpO2

"The following normal ranges SpO2 parameters will be used:~Peripheral Oxygen Saturation: ≥ 95%" (NCT02385097)
Timeframe: from surgery day to 24 hrs post surgery

,
Interventionpercentage of SpO2 (Mean)
baselinedischarge
Chloroprocaine HCl 2% (20 mg/mL)97.0597.47
Ropivacaine 0.75% (7.5 mg/mL)97.3697.61

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Number of Participants With Treatment-emergent Adverse Events (TEAEs)

Number of Participants with Treatment-emergent Adverse Events (TEAEs) occurring or worsening after the first dose of IMP (NCT02385097)
Timeframe: from surgery day to day 6 +/- 1 after surgery

InterventionParticipants (Count of Participants)
Chloroprocaine HCl 2% (20 mg/mL)58
Ropivacaine 0.75% (7.5 mg/mL)76

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Blood Pressure

"The following normal ranges Systolic and Diastolic Blood Pressure parameters will be used:~Systolic Blood Pressure: 100-139 mmHg Diastolic Blood Pressure: 50-89 mmHg" (NCT02385097)
Timeframe: from surgery day to 24 hrs post surgery

,
InterventionmmHg (Mean)
Systolic Blood Pressure at screeningSystolic Blood Pressure at baselineSystolic Blood Pressure at dischargeDiastolic Blood Pressure at screeningDiastolic Blood Pressure at baselineDiastolic Blood Pressure at discharge
Chloroprocaine HCl 2% (20 mg/mL)137136.6130.580.878.274.4
Ropivacaine 0.75% (7.5 mg/mL)136.2138130.180.580.175.4

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Time to Regression of Sensory Block

Will be deemed to have occurred when cold sensation and sensitive perception have returned (if assessable) in any nerve territory (NCT02385097)
Timeframe: Up to 12 hrs after surgery

Interventionminutes (Median)
Chloroprocaine HCl 2% (20 mg/mL)68
Ropivacaine 0.75% (7.5 mg/mL)451

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Time to Regression of Motor Block

Will be deemed to have occurred when motor score is ≥ 3 (Modified Bromage scale) in any nerve territory (Modified Bromage scale: 0-No movement in relevant muscle group,1-Flicker of movement in relevant muscle group,2-Ability to move relevant muscle group against gravity but inability to move against resistance,3-Reduced power but ability to move muscle group against resistance,4-Full power in relevant muscle group) (NCT02385097)
Timeframe: Up to 12 hrs after surgery

Interventionminutes (Median)
Chloroprocaine HCl 2% (20 mg/mL)65
Ropivacaine 0.75% (7.5 mg/mL)415

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Blood Pressure

"The following normal ranges Systolic and Diastolic Blood Pressure parameters will be used:~Systolic Blood Pressure: 100-139 mmHg Diastolic Blood Pressure: 50-89 mmHg" (NCT02481505)
Timeframe: Expected up to 24 hrs post surgery

,,
InterventionmmHg (Mean)
Systolic Blood Pressure screeningSystolic Blood Pressure baselineSystolic Blood Pressure dischargeDiastolic Blood Pressure screeningDiastolic Blood Pressure baselineDiastolic Blood Pressure discharge
3 mL Chloroprocaine HCl 1%120116.9116.981.574.575.5
4 mL Chloroprocaine HCl 1%126127.9124.778.979.879
5 mL Chloroprocaine HCl 1%121.6125.5121.780.579.182

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Transient Neurological Symptoms (TNS)

(NCT02481505)
Timeframe: Up to Day 6 +/- 1 after spinal puncture

,,
Interventionparticipants (Number)
day 2day 7
3 mL Chloroprocaine HCl 1%00
4 mL Chloroprocaine HCl 1%00
5 mL Chloroprocaine HCl 1%00

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SpO2

"The following normal ranges SpO2 parameters will be used:~Peripheral Oxygen Saturation: ≥ 95%" (NCT02481505)
Timeframe: Expected up to 24 hrs post surgery

,,
Interventionpercentage (Mean)
screeningbaselinedischarge
3 mL Chloroprocaine HCl 1%99.799.499.33
4 mL Chloroprocaine HCl 1%99.1399.1399.33
5 mL Chloroprocaine HCl 1%98.5398.5399

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Sensory Block Metameric Level

Metameric level of sensory block assessed from spinal injection (time 0 h) until regression of sensory block to S1 (NCT02481505)
Timeframe: Up to 5 h after regression of two dermatomers

,,
Interventionparticipants (Number)
T2T3T4T6T7T8T10T12L1
3 mL Chloroprocaine HCl 1%013013331
4 mL Chloroprocaine HCl 1%202103151
5 mL Chloroprocaine HCl 1%211412310

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Pain Assessment at the Site of Injection and at the Site of Surgery

Number of patients with pain at the site of injection and at the site of surgery (NCT02481505)
Timeframe: Up to Day 6 +/- 1 after spinal puncture

,,
Interventionparticipants (Number)
Immediately after regression of spinal blockdischargeday 2day 7
3 mL Chloroprocaine HCl 1%001415
4 mL Chloroprocaine HCl 1%001515
5 mL Chloroprocaine HCl 1%001515

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Maximum Level of Sensory Block

Maximum metameric level of sensory block (decreased or absent sensation) achieved (NCT02481505)
Timeframe: Up to 1 h and 40 min after readiness for surgery

,,
Interventionparticipants (Number)
T2T3T4T6T7T8T10T12L1
3 mL Chloroprocaine HCl 1%013013331
4 mL Chloroprocaine HCl 1%202103151
5 mL Chloroprocaine HCl 1%211412310

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Heart Rate

"The following normal ranges Heart Rate parameters will be used:~50-90 beats/min" (NCT02481505)
Timeframe: Expected up to 24 hrs post surgery

,,
Interventionbeats/min (Mean)
screeningbaselinedischarge
3 mL Chloroprocaine HCl 1%62.263.164.9
4 mL Chloroprocaine HCl 1%67.57166.9
5 mL Chloroprocaine HCl 1%70.771.767

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Concentration of 2-chloro-4-aminobenzoic Acid (CABA) in Plasma

(NCT02481505)
Timeframe: at pre-dose, 5, 10, 30 and 60 min after spinal puncture

,,
Interventionminutes (Mean)
5 minutes post-dose10 minutes post-dose30 minutes post-dose60 minutes post-dose
3 mL Chloroprocaine HCl 1%16.12741.44057.45947.020
4 mL Chloroprocaine HCl 1%20.41138.85167.18053.093
5 mL Chloroprocaine HCl 1%24.88775.83397.64778.380

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Time to First Spontaneous Urine Voiding

Time period from spinal injection ( time 0 h) to the first time when the patient can pass urine unassisted (NCT02481505)
Timeframe: Expected up to 24 hrs post surgery

Interventionhours (Mean)
3 mL Chloroprocaine HCl 1%2.530
4 mL Chloroprocaine HCl 1%3.361
5 mL Chloroprocaine HCl 1%3.067

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Time to First Post-operative Analgesia

Time from spinal injection (time 0 h) to first post-operative analgesia (NCT02481505)
Timeframe: Expected up to 24 hrs post surgery

Interventionhours (Mean)
3 mL Chloroprocaine HCl 1%8.186
4 mL Chloroprocaine HCl 1%2.928
5 mL Chloroprocaine HCl 1%2.988

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Time to Eligibility for Home Discharge

Time period from spinal injection (time 0 h) to the time when the criteria from discharge are met, even if according to the hospital procedures the patient is discharged at a later time (NCT02481505)
Timeframe: Expected up to 24 hrs post surgery

Interventionhours (Mean)
3 mL Chloroprocaine HCl 1%3.021
4 mL Chloroprocaine HCl 1%3.545
5 mL Chloroprocaine HCl 1%3.530

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Time to Administration of Rescue Anaesthesia or Rescue Analgesia

(NCT02481505)
Timeframe: Expected up to 24 hrs post surgery

Interventionhours (Mean)
3 mL Chloroprocaine HCl 1%0.717
4 mL Chloroprocaine HCl 1%0.315
5 mL Chloroprocaine HCl 1%0

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Excretion of 2-chloro-4-aminobenzoic Acid (CABA) in Urine

Time period from spinal injection ( time 0 h) to the first time when the patient can pass urine unassisted (NCT02481505)
Timeframe: at the time of first urine voiding post surgery

Interventionng/mL (Mean)
3 mL Chloroprocaine HCl 1%1217.7
4 mL Chloroprocaine HCl 1%1827.9
5 mL Chloroprocaine HCl 1%2103.5

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Time to Resolution of Sensory Block to S1(Min)

Time period from spinal injection (time 0 h) to the time when sensitive perception has returned to S1 (NCT02481505)
Timeframe: Up to 5 h after regression of two dermatomers

Interventionhours (Mean)
3 mL Chloroprocaine HCl 1%1.761
4 mL Chloroprocaine HCl 1%2.127
5 mL Chloroprocaine HCl 1%2.195

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Time to Resolution of Motor Block

Time period from spinal injection (time 0 h) to the time when the Bromage score has returned to 0 (Bromage Scale comprises from 1 to 4, where 1 equals Free movement of legs and feet while 4 stands for Unable to move legs or feet) (NCT02481505)
Timeframe: Up to 5 h after regression of two dermatomers

Interventionhours (Mean)
3 mL Chloroprocaine HCl 1%2.662
4 mL Chloroprocaine HCl 1%3.361
5 mL Chloroprocaine HCl 1%3.213

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Time to Regression of Spinal Block

(NCT02481505)
Timeframe: Up to 1 h and 40 min after readiness for surgery

Interventionhours (Mean)
3 mL Chloroprocaine HCl 1%1.761
4 mL Chloroprocaine HCl 1%2.127
5 mL Chloroprocaine HCl 1%2.229

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Time to Unassisted Ambulation

Time period from spinal injection (time 0 h) to the time when the patient can walk unassisted (NCT02481505)
Timeframe: Up to 5 h after regression of two dermatomers

Interventionhours (Mean)
3 mL Chloroprocaine HCl 1%2.662
4 mL Chloroprocaine HCl 1%3.361
5 mL Chloroprocaine HCl 1%3.213

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Treatment-emergent Adverse Events (TEAEs)

All AEs occurring or worsening after the dose of IMP (NCT02481505)
Timeframe: Up to Day 6 +/- 1 after spinal puncture

,,
Interventionparticipants (Number)
Procedural painInjection site painnauseadiarrheavomitingbradycardia
3 mL Chloroprocaine HCl 1%1420000
4 mL Chloroprocaine HCl 1%1331111
5 mL Chloroprocaine HCl 1%1331000

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Time to Regression of Two Dermatomers With Respect to the Maximum Level of Sensory Block

Time period from spinal injection (time 0 h) to the time when the sensory block decrease of two dermatomers with respect to the maximum level of sensory block (NCT02481505)
Timeframe: Up to 5 h after regression of two dermatomers

Interventionhours (Mean)
3 mL Chloroprocaine HCl 1%0.687
4 mL Chloroprocaine HCl 1%0.851
5 mL Chloroprocaine HCl 1%0.695

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Time to Regression of Spinal Block

When Bromage score returns to 0 and sensitive perception returns to S1 To evaluate the efficacy of the three Chloroprocaine HCI 1% doses (i.e. 30 mg, 40 mg e 50 mg) in terms of time to complete regression of spinal block (i.e. end of anaesthesia) Bromage Score is comprised between 1 and 4 (1 equals Free movement of legs and feet while 4 stands for Unable to move legs or feet) (NCT02481505)
Timeframe: Up to 5 hours after regression of two dermatomers

Interventionminutes (Mean)
3 mL Chloroprocaine HCl 1%40.8
4 mL Chloroprocaine HCl 1%39.4
5 mL Chloroprocaine HCl 1%41.5

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Time to Readiness for Surgery

Time period from completion of spinal injection (time 0 h) to achievement of sensory and motor block adequate for surgery, i.e. loss of Pinprick sensation and Bromage's score ≥ 2 at the required metameric level ≥ T12 (NCT02481505)
Timeframe: Up to 40 min after spinal injection

Interventionminutes (Mean)
3 mL Chloroprocaine HCl 1%8
4 mL Chloroprocaine HCl 1%7.9
5 mL Chloroprocaine HCl 1%5.3

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Time to Onset of Sensory Block (Corresponding to Readiness for Surgery)

Time period from spinal injection (time 0 h) to achievement of sensory block The evolution of both sensory and motor blocks, including sensory block metameric level, will be evaluated every 2 min until readiness for surgery, every 5 min until the maximum level is reached (two consecutive observations with the same level of sensory block) and then every 5 min until regression of two dermatomers with respect to the maximum level of sensory block. (NCT02481505)
Timeframe: Up to 40 min after spinal injection

Interventionminutes (Mean)
3 mL Chloroprocaine HCl 1%5.4
4 mL Chloroprocaine HCl 1%6.6
5 mL Chloroprocaine HCl 1%4.8

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Time to Onset of Motor Block

Time period from spinal injection (time 0 h) to achievement of motor block (NCT02481505)
Timeframe: Up to 40 min after spinal injection

Interventionminutes (Mean)
3 mL Chloroprocaine HCl 1%6.3
4 mL Chloroprocaine HCl 1%6
5 mL Chloroprocaine HCl 1%4.4

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Time to Maximum Level of Sensory Block

Time period from spinal injection (Tsp; time 0 h) to the time when the maximum metameric level of sensory block is achieved (consider the time of the first of the two consecutive observations with the same level of sensory block) (NCT02481505)
Timeframe: Up to 1 h and 40 min after readiness for surgery

Interventionminutes (Mean)
3 mL Chloroprocaine HCl 1%0.224
4 mL Chloroprocaine HCl 1%0.235
5 mL Chloroprocaine HCl 1%0.234

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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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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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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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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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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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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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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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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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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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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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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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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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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 < 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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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 < 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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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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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 < 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 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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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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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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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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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 < 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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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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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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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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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

[back to top]

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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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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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: 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: 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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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 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: 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 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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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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Time to Void

Time from spinal anesthesia injection to ability to void spontaneously. (NCT02862912)
Timeframe: 5 hours

Interventionminutes (Median)
Bupivacaine (BUP)229
Chloroprocaine (CP)158

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Time to Resolution of Motor Block

"The mean difference between groups in time between the end of spinal injection (t IT) to time for no motor block (t motor), i.e. tIT - T motor. Motor block will be assessed using the Bromage scale:~Bromage Scale I = free movement of the legs and feet = no block II = able to flex knees, with free movement of feet = partial (33%) block III = unable to flex knees, but with free movement of the feet = almost complete (66%) block IV = unable to move legs or feet = complete block (100%)" (NCT02862912)
Timeframe: 3 hours

Interventionminutes (Median)
Chloroprocaine (CP)109
Bupivacaine (BUP)112

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Time to Ambulate

Time from spinal anesthesia placement to ability to ambulate. (NCT02862912)
Timeframe: 5 hours

Interventionminutes (Median)
Chloroprocaine (CP)158
Bupivacaine (BUP)229

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Quality of the Block

Quality of the block assessed between 10 and 20 min after the end of surgery by the anaesthesiologist and patient together using a 0-10 cm visual analogue scale (VAS; 10=excellent anaesthetic quality, 0=very poor anaesthetic quality) (NCT02919072)
Timeframe: Quality of the block assessed between 10 and 20 minutes after the end of surgery

Interventionunits on a scale (Mean)
Chloroprocaine9.8
Ropivacaine8.4

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Time to the Onset of Anaesthesia

The time from T0 (start time of the epidural injection) to complete loss of cold sensation to the metameric level T4 (block to T4), bilateral. (NCT02919072)
Timeframe: Up to 1 hour after last epidural injection

Interventionminutes (Mean)
Chloroprocaine9
Ropivacaine9.1

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Time From T0 to Loss Light Touch Sensation

Time from T0 to loss light touch sensation to the metameric level T5 (block to T5), bilateral (NCT02919072)
Timeframe: Up to 1 hour after last epidural injection

Interventionminutes (Mean)
Chloroprocaine9.3
Ropivacaine13.3

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Duration of Sensory Block

The time difference between local anesthetic injection and complete resolution of sensory block. The sensory level was tested using a blunt needle tip along the patient's demratomal distribution of the spinal anesthetic. (NCT03305575)
Timeframe: 6 hours

Interventionminutes (Mean)
Chloroprocaine127
Bupivacaine210

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Time to Ambulation

The time difference between local anesthetic injection and patient's walking for the first time postoperatively. (NCT03305575)
Timeframe: 6 hours

Interventionminutes (Mean)
Chloroprocaine110
Bupivacaine179

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Time to Micturation

The time difference between local anesthetic injection and the patient's voiding for the first time postoperatively. (NCT03305575)
Timeframe: 6 hours

Interventionminutes (Mean)
Chloroprocaine111
Bupivacaine233

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Duration of Motor Block

"The time difference between local anesthetic injection and complete resolution of motor block -as measured on the Bromage scale:~I = free movement of feet, legs and hip = No block II = able to flex knees, with free movement of feet = Mild block III = unable to flex knees, but with free movement of feet = Moderate block IV = unable to move legs or feet = Complete block" (NCT03305575)
Timeframe: 6 hours

Interventionminutes (Mean)
Chloroprocaine75
Bupivacaine99

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Readiness for Discharge

Defined as duration from arrival in the post-anesthesia care unit (PACU0 to the time patient meets the discharge criteria from the post anesthesia discharge scoring system (PADSS) for home readiness after ambulatory surgery (NCT03365752)
Timeframe: Determine within 24 hours after surgery

Interventionminutes (Mean)
Chloroprocaine141.85
Mepivacaine174.31
General Anesthesia170.69

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Pain Intensity as Measured by 11-point Verbal Numeric Rating Scale (NRS-11) for Pain.

Pain intensity prior to intervention and at 5 minute intervals after intervention. The 11-point Numeric Rating Scale quantifies a subject's pain experience from 0/10 (no pain) to 10/10 (worst pain imaginable). (NCT03395990)
Timeframe: Baseline, up to 30 minutes.

,
Interventionunits on a scale (Median)
Pre-block5 minutes post-block10 minutes post-block15 minutes post-block20 minutes post-block25 minutes post-block30 minutes post-block
Chloroprocaine7.04.04.03.23.03.02.0
Saline6.06.06.56.56.05.55.5

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The Onset Time to Surgical Anesthesia

The onset time to surgical anesthesia, as reported by the participant using a standard procedure This will be measured by the time taken from the end of the epidural loading dose to develop a loss of touch sensation using a neurotip® (Owen Mumford, USA) device bilaterally at the T7 dermatomal level using a non-inferiority study design. A non-inferiority limit of 3 minutes was chosen apriori. (NCT03414359)
Timeframe: Up to 35 minutes

Interventionseconds (Mean)
2% Lidocaine558
3% Chloroprocaine655

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Secondary Outcome: Number of Participants With Requirement for Intraoperative Analgesia Supplementation

This requirement for any rescue medications to control discomfort or pain during CD (NCT03414359)
Timeframe: 1 hour

InterventionParticipants (Count of Participants)
2% Lidocaine4
3% Chloroprocaine7

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Time to Regression of Spinal Block

Time period from spinal injection to the complete regression of sensory block to S1. (NCT03428230)
Timeframe: Up to 4 hours after injection

Interventionminutes (Median)
30 mg Paracetamol 3% (1 mL)100
60 mg Paracetamol 3% (2 mL)100
90 mg Paracetamol 3% (3 mL)90
Placebo, 0.9% Saline Solution95

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Time to Sensory Block

Time to maximum level of sensory block (bilateral Pinprick test using a 20-G hypodermic needle) (NCT03428230)
Timeframe: Intraoperative

Interventionminutes (Median)
30 mg Paracetamol 3% (1 mL)10
60 mg Paracetamol 3% (2 mL)10
90 mg Paracetamol 3% (3 mL)10
Placebo, 0.9% Saline Solution10

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Total Number of Partecipants Receiving Analgesic 1

Total number of partecipants receiving Ketorolac i.v. [Toradol] 30 mg (NCT03428230)
Timeframe: From surgery day to 24 hours after surgery

InterventionParticipants (Count of Participants)
30 mg Paracetamol 3% (1 mL)6
60 mg Paracetamol 3% (2 mL)5
90 mg Paracetamol 3% (3 mL)7
Placebo, 0.9% Saline Solution1

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Total Number of Partecipants Receiving Analgesic 2

Total Number of Partecipants Receiving Tramadol i.v. 1 mg/kg (NCT03428230)
Timeframe: from surgery day to 24 hours after surgery

InterventionParticipants (Count of Participants)
30 mg Paracetamol 3% (1 mL)2
60 mg Paracetamol 3% (2 mL)0
90 mg Paracetamol 3% (3 mL)4
Placebo, 0.9% Saline Solution0

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Pain at Rest AUCt1-t2

AUC t1-t2 is defined as the area under the pain intensity curve at the specified time-intervals (NCT03428230)
Timeframe: Up to 4 hours after injection

,,,
Interventionscore on a scale*h (Mean)
AUC 0-2 hoursAUC 0-4 hours
30 mg Paracetamol 3% (1 mL)1334.6
60 mg Paracetamol 3% (2 mL)14.826
90 mg Paracetamol 3% (3 mL)26.492.2
Placebo, 0.9% Saline Solution4.449.7

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Percentage of Patients Requiring Analgesia From Surgery End Until Eligibility for Discharge

Percentage of patients requiring analgesia (level 1 or level 2) from surgery end until eligibility for home discharge (NCT03428230)
Timeframe: from surgery day to 24 hours after surgery

InterventionParticipants (Count of Participants)
30 mg Paracetamol 3% (1 mL)6
60 mg Paracetamol 3% (2 mL)5
90 mg Paracetamol 3% (3 mL)7
Placebo, 0.9% Saline Solution1

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Pain Intensity at Rest Evaluated Using a 0-100 mm VAS

The study primary efficacy measures will be the VAS scores at each predefined time-point after the anaesthetic intrathecal injection until eligibility for home discharge ( VAS scale is 0-100 mm, where 0 is no pain and 100 is maximum pain) (NCT03428230)
Timeframe: Pain intensity at rest evaluated using a 0-100 mm VAS at baseline (within 30 min before NIMP IT injection, 0 h), 1, 1.25, 1.5, 1.75, 2 h after NIMP IT injection, then every 30 min after NIMP IT injection until eligibility for home discharge.

,,,
Interventionscore on a scale (Mean)
baseline1 hour after NIMP1.25 hour after NIMP1.50 hour after NIMP1.75 hour after NIMP2 hours after NIMP2.5 hours after NIMP3 hours after NIMP3.5 hours after NIMP4 hours after NIMP4.5 hours after NIMPbefore discharge
30 mg Paracetamol 3% (1 mL)9.60.14.65.99.514.116.92119.76.82.53.7
60 mg Paracetamol 3% (2 mL)16.90.11.94.515.117.88.79.66.813.304.1
90 mg Paracetamol 3% (3 mL)18.43.46.216.421.422.814.77.314.215.322.9
Placebo, 0.9% Saline Solution8.100.61.23.63.97.210.411.40011.3

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Percentage of Patients Requiring Supplementary Analgesia, Other Than the Planned Level 1 or 2 Analgesia

Percentage of patients requiring supplementary analgesia, other than the planned level 1 or 2 analgesia (NCT03428230)
Timeframe: from surgery day to 24 hours after surgery

,,,
Interventionparticipants (Number)
level 1level 2
30 mg Paracetamol 3% (1 mL)62
60 mg Paracetamol 3% (2 mL)50
90 mg Paracetamol 3% (3 mL)74
Placebo, 0.9% Saline Solution10

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Number of Participants With Neurological Complications Including TNS

Number of Participants with Neurological Complications Including TNS at 24 h post-dose and at day 7±1 (NCT03428230)
Timeframe: From anaesthetic intrathecal injection up to day 7±1 (i.e. 6±1 days after analgesic/anaesthetic IT injection and surgery)

InterventionParticipants (Count of Participants)
30 mg Paracetamol 3% (1 mL)0
60 mg Paracetamol 3% (2 mL)0
90 mg Paracetamol 3% (3 mL)0
Placebo, 0.9% Saline Solution0

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Pain at Rest AUClast

AUClast is defined as the area under the pain intensity curve from 0 h up to the last assessment time (NCT03428230)
Timeframe: Up to 24 hours after injection

Interventionscore on a scale*h (Mean)
30 mg Paracetamol 3% (1 mL)34
60 mg Paracetamol 3% (2 mL)24.7
90 mg Paracetamol 3% (3 mL)42
Placebo, 0.9% Saline Solution15.7

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Partecipants Received Level 2 Analgesia

Partecipants received Tramadol i.v. 1 mg/kg administration (level 2 analgesia) (NCT03428230)
Timeframe: from surgery day to 24 hours after surgery

InterventionParticipants (Count of Participants)
30 mg Paracetamol 3% (1 mL)2
60 mg Paracetamol 3% (2 mL)0
90 mg Paracetamol 3% (3 mL)4
Placebo, 0.9% Saline Solution0

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Partecipants to Received Level 1 Analgesia

Partecipants to received Ketorolac i.v. [Toradol] 30 mg administration (level 1 analgesia) (NCT03428230)
Timeframe: from surgery day to 24 hours after surgery

InterventionParticipants (Count of Participants)
30 mg Paracetamol 3% (1 mL)6
60 mg Paracetamol 3% (2 mL)5
90 mg Paracetamol 3% (3 mL)7
Placebo, 0.9% Saline Solution1

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Time to Eligibility for Discharge

Time to eligibility for home discharge (NCT03428230)
Timeframe: Up to 24 hours after injection

Interventionminutes (Median)
30 mg Paracetamol 3% (1 mL)170
60 mg Paracetamol 3% (2 mL)165
90 mg Paracetamol 3% (3 mL)170
Placebo, 0.9% Saline Solution168

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Percentage of Patients Requiring Analgesia in the First 2 h After Surgery End

Percentage of patients requiring analgesia (level 1 or level 2) in the first 2 h after surgery end (NCT03428230)
Timeframe: Form surgery day to 2 hours after surgery end

InterventionParticipants (Count of Participants)
30 mg Paracetamol 3% (1 mL)5
60 mg Paracetamol 3% (2 mL)3
90 mg Paracetamol 3% (3 mL)7
Placebo, 0.9% Saline Solution0

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Percentage of Patients Requiring Analgesia in the First 4 h After Surgery End

Percentage of patients requiring analgesia (level 1 or level 2) in the first 4 h after surgery end (NCT03428230)
Timeframe: from surgery day to 4 hours after surgery end

InterventionParticipants (Count of Participants)
30 mg Paracetamol 3% (1 mL)6
60 mg Paracetamol 3% (2 mL)5
90 mg Paracetamol 3% (3 mL)7
Placebo, 0.9% Saline Solution1

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Percentage of Patients Requiring Level 1 Analgesia From Surgery End Until Eligibility for Discharge

Percentage of patients requiring level 1 analgesia from surgery end until eligibility for home discharge (NCT03428230)
Timeframe: from surgery day to 24 hours after surgery

InterventionParticipants (Count of Participants)
30 mg Paracetamol 3% (1 mL)6
60 mg Paracetamol 3% (2 mL)5
90 mg Paracetamol 3% (3 mL)7
Placebo, 0.9% Saline Solution1

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Percentage of Patients Requiring Level 2 Analgesia From Surgery End Until Eligibility for Discharge

Percentage of Patients Requiring Level 2 Analgesia From Surgery End Until Eligibility for Home Discharge (NCT03428230)
Timeframe: from surgery day to 24 hours after surgery

InterventionParticipants (Count of Participants)
30 mg Paracetamol 3% (1 mL)2
60 mg Paracetamol 3% (2 mL)0
90 mg Paracetamol 3% (3 mL)4
Placebo, 0.9% Saline Solution0

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Percentage of Patients Requiring Rescue Anaesthesia

Percentage of patients requiring rescue anaesthesia (NCT03428230)
Timeframe: from surgery day to 1 hour after injection

InterventionParticipants (Count of Participants)
30 mg Paracetamol 3% (1 mL)14
60 mg Paracetamol 3% (2 mL)15
90 mg Paracetamol 3% (3 mL)15
Placebo, 0.9% Saline Solution14

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Time to Ambulation

Time to unassisted ambulation (NCT03428230)
Timeframe: Up to 24 hours after injection

Interventionminutes (Median)
30 mg Paracetamol 3% (1 mL)139
60 mg Paracetamol 3% (2 mL)115
90 mg Paracetamol 3% (3 mL)125
Placebo, 0.9% Saline Solution125

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Time to First Urine

Time to first spontaneous urine voiding (NCT03428230)
Timeframe: Up to 24 hours after injection

Interventionminutes (Median)
30 mg Paracetamol 3% (1 mL)155
60 mg Paracetamol 3% (2 mL)140
90 mg Paracetamol 3% (3 mL)145
Placebo, 0.9% Saline Solution150

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Time to Onset of Spinal Block (i.e. Time to Readiness for Surgery)

Spinal block/Readiness for surgery is defined as the presence of an adequate motor block (Bromage's score ≥ 2) and loss of Pinprick sensation, according to the Investigator's opinion. Time to readiness for surgery is defined as the time from the spinal injection (time 0 h) to achievement of readiness for surgery. (NCT03428230)
Timeframe: Up to 20 minutes after injection

Interventionminutes (Median)
30 mg Paracetamol 3% (1 mL)5
60 mg Paracetamol 3% (2 mL)5
90 mg Paracetamol 3% (3 mL)2
Placebo, 0.9% Saline Solution5

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Time to Resolution of Motor Block at End of the Cerclage Placement (Measured in the PACU).

The motor block is assessed using the Bromage scale (1-5). The block is objectively assessed using this scale based on which joints a patient is able to mobilize following epidural or subarachnoid block. A score of 1 represents a patient who is unable to mobilize any lower extremity joint. A score of 5 represents a patient able to mobilize all lower extremity joints. (NCT03805438)
Timeframe: 60 minutes

Interventionminutes (Mean)
Chloroprocaine Dose60

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The Dose of Intrathecal (IT) Chloroprocaine That Provides Effective Anesthesia in 90% of Patients Undergoing Elective Cerclage Placement (Intraoperative Analgesic Supplementation Not Required).

Identification of the dose of intrathecal 3% chloroprocaine that will provide adequate anesthesia for a cervical cerclage to occur. (NCT03805438)
Timeframe: 60 minutes

Interventionmg (Number)
Chloroprocaine Dose49.5

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Time From Spinal Block to Ambulation

(NCT03805438)
Timeframe: up to 180 minutes

Interventionminutes (Mean)
Chloroprocaine Dose60

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Time From Spinal Block to Micturition

(NCT03805438)
Timeframe: approximately 180 minutes

Interventionminutes (Mean)
Chloroprocaine Dose150

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Time to Complete Sensory Regression

(NCT03805438)
Timeframe: up to 180 minutes

Interventionminutes (Mean)
Chloroprocaine Dose90

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Time to Hospital Discharge as Measured as the Time Difference Between Local Anesthetic Injection and Discharge Time as Recorded in the Medical Notes

(NCT03805438)
Timeframe: approximately 180 minutes

Interventionminutes (Mean)
Chloroprocaine Dose150

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Time to Readiness for PACU Discharge (Pre-defined Nursing Criteria)

Readiness for PACU discharge would include a patient who is able to ambulate unassisted (indicating resolution of motor block), has vital signs within normal limits, has pain levels acceptable to the patient, and has been able to urinate. (NCT03805438)
Timeframe: approximately 180 minutes

Interventionminutes (Mean)
Chloroprocaine Dose150

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Time to Resolution of Motor Block (Bromage Score of 5)

The motor block is assessed using the Bromage scale (1-5). The block is objectively assessed using this scale based on which joints a patient is able to mobilize following epidural or subarachnoid block. A score of 1 represents a patient who is unable to mobilize any lower extremity joint. A score of 5 represents a patient able to mobilize all lower extremity joints. (NCT03805438)
Timeframe: up to 180 minutes

Interventionminutes (Mean)
Chloroprocaine Dose60

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Number of Patients Who Were Given Vasopressor Phenylephrine (and Ephedrine) BP Drops Greater Than 15% Below Baseline or < 100mg Hg Systolic.

(NCT03805438)
Timeframe: 60 minutes

InterventionParticipants (Count of Participants)
Chloroprocaine Dose13

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Overall Patient Satisfaction at Time of PACU Discharge.

The scale used is 0-10 where 0 would represent completely unsatisfied and 10 would be completely satisfied. A 10 would imply that if a participant had to have the procedure performed again, it would be repeated in the exact same fashion it was carried out the first time. This will be assessed at the time of PACU discharge and will be asked one time. No subscales are used. (NCT03805438)
Timeframe: 60 minutes

Interventionscore on a scale (Mean)
Chloroprocaine Dose10

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The Average Dose of Phenylephrine Given to Those Patients Whose BP Dropped Greater Than 15% Below Baseline or < 100mg Hg Systolic.

All patients were analyzed for possible requirement of this intervention, though all participants did not require the intervention. (NCT03805438)
Timeframe: 60 minutes

Interventionmg (Mean)
Chloroprocaine Dose320

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Number of Participants With Observed Vomiting. (Observed Yes or no).

Number of participants with observed vomiting. (NCT03805438)
Timeframe: 60 minutes

InterventionParticipants (Count of Participants)
Chloroprocaine Dose1

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Number of Participants Who Reported Nausea (Self-reported by Patient, Yes or no).

Number of participants reporting nausea. (NCT03805438)
Timeframe: 60 minutes

InterventionParticipants (Count of Participants)
Chloroprocaine Dose8

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Number of Participants Reporting Itching. (Self-reported by Patient, Yes or no).

Number of participants reporting itching. (NCT03805438)
Timeframe: 60 minutes

InterventionParticipants (Count of Participants)
Chloroprocaine Dose2

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Maximum Pain Numerical Pain Rating Scale (NPRS) During Surgery (as Reported by Patient, Scored From 0-10 in the PACU).

The scale from 0-10 is used where a score of 0 represents no pain at all and a score of 10 represents the worst pain a participant could imagine. It is reported as a single score at a single point in time. No subscales are used. (NCT03805438)
Timeframe: 60 minutes

Interventionscore on a scale (Mean)
Chloroprocaine Dose0

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Time to PACU Discharge

Time required for readiness for discharge from Post Anesthesia Care Unit (PACU) (NCT03993314)
Timeframe: Day of surgery

Interventionminutes (Median)
Bupivacaine57
Chloroprocaine45

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Level of Numbness

"The degree to which participants experience analgesia. Degree of analgesia is determined by the level of the block. Block level may be T1 (highest level of numbness), T2, T3, T4, T5, T6, T7,T8, T9 , T10, T11, T12, L1, L2, L3, or L4 (lowest level or numbness).~Participants are assigned a numerical score according to level of the block. Numerical scores were assigned so that a higher score indicates better outcome (i.e., greater level of numbness):~T1 = 16 points; T2 = 15 points; T3 = 14 points; T4 = 13 points; T5 = 12 points; T6 = 11 points; T7 = 10 points; T8 = 9 points; T9 = 8 points; T10 = 7 points; T11 = 6 points; T12 = 5 points; L1 = 4 points; L2 = 3 points; L3 = 2 points; L4 = 1 point" (NCT03993314)
Timeframe: 10 minutes after spinal injection

Interventionscore on a scale (Median)
Bupivacaine15
Chloroprocaine12.5

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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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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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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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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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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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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: 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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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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Corneal Thickness

Modification of the basal status of the assesment (Corneal thickness). Measurement of the central corneal thickness was to be performed with a pachymeter (NCT04685538)
Timeframe: Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days

,
Interventionum (Mean)
visit 1 (Day -90/Day -1)visit 4 (Day 8 ± 1 day)
Chloroprocaine 3%539.59557.8
Tetracaine 0.5%536.59546.54

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Changes in Ocular Symptoms

Changes in ocular symptoms (pain, irritation/burning/stinging, foreign body sensation) will be graded by the patients according to the following scale (0 is the minimum value and 3 is tha maximum value) (0 = absent, 1 = mild, 2 = moderate, 3 = severe) during the study on Visit 1-selection and on visit 4-final (NCT04685538)
Timeframe: Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days

,
Interventionscore on a scale (Mean)
Foreign Body Sensation visit1Foreign Body Sensation visit4Irritation/Burning/Stinging visit1Irritation/Burning/Stinging visit4pain visit1pain visit4
Chloroprocaine 3%0.080.190.110.110.010.05
Tetracaine 0.5%0.060.170.110.150.010.05

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Best Far Corrected Visual Acuity

Modification of the basal status of the assesment evaluated by LogMAR (Logarithm of the Minimum Angle of Resolution). When using a LogMAR chart, visual acuity is scored with reference to the logarithm of the minimum angle of resolution, as the chart's name suggests. An observer who can resolve details as small as 1 minute of visual angle scores LogMAR 0, since the base-10 logarithm of 1 is 0; an observer who can resolve details as small as 2 minutes of visual angle (i.e., reduced acuity) scores LogMAR 0.3, since the base-10 logarithm of 2 is near-approximately 0.3; and so on. (NCT04685538)
Timeframe: Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days

,
InterventionLogMAR (Mean)
Best Corrected Visual Acuity LogMAR visit1Best Corrected Visual Acuity LogMAR visit4
Chloroprocaine 3%0.490.12
Tetracaine 0.5%0.470.08

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Surgeon Satisfaction

"Evaluation of surgeon satisfaction. Surgeon satisfaction was assessed through the question How do you consider the study product global tolerance?, at a scale (a score of 0 is the minimum value with the best outcome and 3 is the maximum value with the worst outcome): (0) Very satisfactory, (1) Satisfactory, (2) Not very satisfactory, (3) Unsatisfactory. It is recorded at V2 and filled in by the surgeon who had performed the study. It is measured at Visit 2." (NCT04685538)
Timeframe: day 1 - visit2 (Inclusion visit/Surgery)

Interventionscore on a scale (Mean)
Chloroprocaine 3%0.17
Tetracaine 0.5%0.17

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Objective Ocular Signs

- Objective ocular signs assessed by slit lamp examination, flare, and other objective ocular signs will be graded according to the following scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe. The minimum value is 0 and maximum value is 3 (NCT04685538)
Timeframe: Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days

,
Interventionscore on a scale (Mean)
Anterior Chamber Cells and Flare visit1Anterior Chamber Cells and Flare visit4Chemosis visit1Chemosis visit4
Chloroprocaine 3%00.040.030.09
Tetracaine 0.5%00.030.040.09

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Patient Global Satisfaction

"Patient global satisfaction at D1 based on a 5-question questionnaire read by a masked observer.~A question read by a masked observer assessed the patient satisfaction about the overall anesthesia during the surgery: Overall, how satisfied are you with the topical study product used for your local anesthesia during your cataract surgery? It was measured with 5 possible answers (Likert satisfaction scale): Very satisfied (0), Globally satisfied (1), Neither satisfied nor Unsatisfied (2), Globally unsatisfied (3), Very unsatisfied (4). It was measured at Visit 3." (NCT04685538)
Timeframe: day 1 - visit2 (Inclusion visit/Surgery) after the treatment

Interventionscore on a scale (Mean)
Chloroprocaine 3%1.35
Tetracaine 0.5%1.27

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Number of Participants in Each Treatment Group With a Successful Surface Anesthesia

Τhe primary endpoint is the number of partecipants in each treatment group with a successful surface anesthesia, without any supplementation at the time point T4 (1 minute after the 3rd drop installation) (NCT04685538)
Timeframe: Before Intra Ocular Lens (IOL) implantation surgery.

,
Interventionparticipants (Number)
Anesthesia SuccessAnesthesia NO Success
Chloroprocaine 3%15314
Tetracaine 0.5%15219

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Intra-ocular Pressure

Modification of the basal status of the assesment. Intraocular pressure (in mmHg) was assessed according to site current practice (air puff or applanation tonometer). (NCT04685538)
Timeframe: Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days

,
InterventionmmHg (Mean)
visit 1 Selectionvisit 4 Final
Chloroprocaine 3%1514.7
Tetracaine 0.5%1514.88

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Fluoresceine

Modification of the basal status evaluated with fluorescein test Approximately 2-3 minutes following fluorescein instillation, corneal staining was to be evaluated in both eyes, using a slit lamp, based on the Oxford scale (grades of 0-5: 0 is normal, 5 is severe abnormal). (NCT04685538)
Timeframe: Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days

,
Interventionscore on a scale (Mean)
Corneal Fluorescein Staining visit1Corneal Fluorescein Staining visit4
Chloroprocaine 3%0.210.32
Tetracaine 0.5%0.160.25

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Endothelial Cell Counts

Modification of the basal status of the Endothelial cell counts evaluated with the specular microscopy (NCT04685538)
Timeframe: Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days

,
Interventioncell/mm^2 (Mean)
Endothelial Cells Count [cell/mm2] visit1Endothelial Cells Count [cell/mm2] visit4
Chloroprocaine 3%2440.762049.88
Tetracaine 0.5%2511.892166.96

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Number of Participants With Abnormalities of the Retina, Macula, or Optic Nerve by Fundoscopy

Modification of the basal status of the assesment. Dilated fundus examination on retina, macula, optic nerve. (NCT04685538)
Timeframe: Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days

,
InterventionParticipants (Count of Participants)
macula abnormal V1macula abnormal V4optic nerve abnormal V1optic nerve abnormal V4retina abnormal V1retina abnormal V4
Chloroprocaine 3%151316121313
Tetracaine 0.5%161016101112

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