Page last updated: 2024-12-05

prilocaine

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Description

Prilocaine is a topical and injectable local anesthetic that works by blocking nerve impulses. It is a synthetic compound derived from ortho-toluidine. Prilocaine is primarily used in dentistry, surgery, and dermatology for pain relief. It is often combined with other anesthetics, such as lidocaine, to enhance its effects. Research on prilocaine focuses on its efficacy, safety, and potential applications in various medical settings. It is particularly studied for its use in managing pain during childbirth and for its potential as an adjunct to other pain management strategies.'

Prilocaine: A local anesthetic that is similar pharmacologically to LIDOCAINE. Currently, it is used most often for infiltration anesthesia in dentistry. [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

prilocaine : An amino acid amide in which N-propyl-DL-alanine and 2-methylaniline have combined to form the amide bond; used as a local anaesthetic. [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 CID4906
CHEMBL ID1194
CHEBI ID8404
SCHEMBL ID25467
MeSH IDM0017571

Synonyms (148)

Synonym
n-(2-methylphenyl)-n(2)-propylalaninamide
prilocainum
prilocaina
AC-2100
prilocaine [usan:usp:inn:ban]
unii-046o35d44r
046o35d44r ,
AB00053665-12
BRD-A53952395-003-05-3
nsc-40027
propitocaine
o-propionotuluidide, 2-propylamino-
nsc40027
2-methyl-.alpha.-propylaminopropionanilide
astra 1512
l 67
propanamide, n-(2-methylphenyl)-2-(propylamino)-
o-methyl-2-propylaminopropionanilide
astra 1515
citanest
o-propionotoluidide, 2-(propylamino)-
DIVK1C_000846
KBIO1_000846
prilocaina [inn-spanish]
prilocaine [usan]
prilocainum [inn-latin]
nsc 40027
l-67
hsdb 3386
einecs 211-957-0
o-propionotoluidide, 2-propylamino-
brn 2108498
SPECTRUM_001649
LOPAC0_001005
PRESTWICK3_000199
BSPBIO_002604
BPBIO1_000173
BSPBIO_000157
SPECTRUM5_001175
IDI1_000846
AB00053665
721-50-6
prilocaine
C07531
n-(2-methylphenyl)-2-(propylamino)propanamide
prilocaine base
2-methyl-alpha-propylaminopropionanilide
alpha-n-propylamino-2-methylpropionanilide
o-methyl-alpha-propylaminopropionanilide
DB00750
2-(propylamino)-o-propionotoluidide
prilocaine (usp/inn)
propitocaine (jan)
D00553
KBIO3_001824
KBIOSS_002129
KBIOGR_001883
KBIO2_002129
KBIO2_007265
KBIO2_004697
SPBIO_002078
PRESTWICK1_000199
SPECTRUM4_001192
NINDS_000846
PRESTWICK0_000199
SPECTRUM2_001549
SPECTRUM3_001052
SPBIO_001398
n-(2-methylphenyl)-n2-propylalaninamide
PRESTWICK2_000199
NCGC00162312-01
NCGC00015860-03
CHEMBL1194
chebi:8404 ,
astra-1515
astra-1512
FT-0660568
A837435
n-(2-methylphenyl)-n~2~-propylalaninamide
STL257086
CCG-205085
NCGC00015860-02
FT-0603506
S1619
AKOS015889404
n-(2-methylphenyl)-2-(propylamino)propanimidic acid
gtpl7276
prilotekal
prilocaine [usp-rs]
prilocaine component of fortacin
prilocaine [ep monograph]
oraqix component prilocaine
prilocaine component of oraqix
emla component prilocaine
prilocaine [hsdb]
prilocaine [vandf]
fortacin component prilocaine
n-(2,6-dimethylphenyl)-2-(propylamino)propanamide
prilocaine [orange book]
(+/-)-prilocaine
dl-(+/-)-prilocaine
prilocaine [inn]
17676-07-2
(+/-)-n-(2-propylaminopropionyl)-2-toluidine
prilocaine [usp monograph]
prilocaine [mart.]
prilocaine [mi]
prilocaine component of emla
prilocaine [who-dd]
propitocaine [jan]
HY-B0137
CS-1929
SCHEMBL25467
2-(propylamino)-n-(o-tolyl)propanamide
Q-100809
MVFGUOIZUNYYSO-UHFFFAOYSA-N
o-methyl-.alpha.-propylaminopropionanilide
(.+/-.)-prilocaine
.alpha.-n-propyl-amino-2-methylpropionanilide
n-(2-methylphenyl)-2-(propylamino)propanamide #
HMS3604H09
AB00053665_14
AB00053665_13
DTXSID7031955 ,
HMS3651M13
mfcd00048681
SBI-0050978.P003
SW196783-3
2-(propylamino)-n-o-tolylpropanamide
AS-14851
bdbm50225477
Q413598
BRD-A53952395-003-15-2
SDCCGSBI-0050978.P004
HMS3884A04
NCGC00015860-15
EN300-188120
Z44530398
prilocaine (ep monograph)
prilocaine (usp-rs)
prilocain
prilocaine (usan:usp:inn:ban)
dtxcid5011955
prilocaine (usp monograph)
prilocaine (mart.)
prilocainum (inn-latin)
prilocaina (inn-spanish)
n01bb04

Research Excerpts

Overview

Prilocaine is an amide local anesthetic with a duration of action similar to that of lidocaine. It is widely used in clinical practice, but usage in infancy easily causes methemoglobinemia.

ExcerptReferenceRelevance
"Prilocaine is a widely used local anesthetic and can cause methemoglobinemia in infants even in therapeutic doses."( [Acute cyanosis after transcatheter balloon valvuloplasty: toxic methemoglobinemia due to local prilocaine use].
Dindar, A; Ergül, Y; Kalkandelen, S; Nişli, K, 2011
)
1.31
"Prilocaine appeared to be a safe local anaesthetic for use with either continuous spinal anaesthesia or continuous epidural anaesthesia."( Anaesthetic and haemodynamic effects of continuous spinal versus continuous epidural anaesthesia with prilocaine.
Celik, J; Otelcioglu, S; Reisli, R; Tuncer, S; Yosunkaya, A, 2003
)
1.26
"Prilocaine is a useful alternative anaesthetic agent for eye surgery that has low toxicity and is effective without adrenaline."( Peribulbar anaesthesia for cataract surgery: prilocaine versus lignocaine and bupivacaine.
Franks, W; Henderson, TR, 1996
)
2
"Prilocaine is an amide local anesthetic with a duration of action similar to that of lidocaine."( Transient neurologic symptoms after spinal anesthesia: a lower incidence with prilocaine and bupivacaine than with lidocaine.
Drasner, K; Hampl, KF; Harms, C; Heinzmann-Wiedmer, S; Luginbuehl, I; Schneider, MC; Seeberger, M, 1998
)
1.25
"Prilocaine is a local anesthetic that is widely used in clinical practice, but usage in infancy easily causes methemoglobinemia."( Toxic methemoglobinemia after injection of prilocaine in a newborn. A case report.
Aygün, C; Kara, A; Oran, O; Yiğit, S,
)
1.12
"Prilocaine is a more comfortable local infiltration anaesthetic agent than lignocaine when used for minor eyelid procedures."( Prilocaine versus lignocaine for minor lid procedures.
Backhouse, O; Burton, AJ; Metcalfe, TW, 2000
)
3.19

Effects

Prilocaine plain has a high pH and concentration (4%), which could decrease the pain of injection and increase success. It has a similar intrathecal pharmacokinetic profile as lidocaine but with a significantly lower risk of TNSs.

ExcerptReferenceRelevance
"Prilocaine plain has a high pH and concentration (4%), which could decrease the pain of injection and increase success. "( Anesthetic Efficacy of a Combination of 4% Prilocaine/2% Lidocaine with Epinephrine for the Inferior Alveolar Nerve Block: A Prospective, Randomized, Double-blind Study.
Cook, O; Draper, J; Drum, M; Fowler, S; Nusstein, J; Reader, A, 2018
)
2.19
"Prilocaine has a similar intrathecal pharmacokinetic profile as lidocaine but with a significantly lower risk of TNSs. "( Speed spinal anesthesia revisited: new drugs and their clinical effects.
Hampl, K; Steinfeldt, T; Wulf, H, 2013
)
1.83
"Prilocaine plain has a high pH and concentration (4%), which could decrease the pain of injection and increase success. "( Anesthetic Efficacy of a Combination of 4% Prilocaine/2% Lidocaine with Epinephrine for the Inferior Alveolar Nerve Block: A Prospective, Randomized, Double-blind Study.
Cook, O; Draper, J; Drum, M; Fowler, S; Nusstein, J; Reader, A, 2018
)
2.19
"Prilocaine has a similar intrathecal pharmacokinetic profile as lidocaine but with a significantly lower risk of TNSs. "( Speed spinal anesthesia revisited: new drugs and their clinical effects.
Hampl, K; Steinfeldt, T; Wulf, H, 2013
)
1.83
"Prilocaine plain has been described in the literature as causing less pain on injection than bupivacaine with epinephrine, possibly because of the higher pH of the prilocaine anesthetic solution."( Injection pain of bupivacaine with epinephrine vs. prilocaine plain.
Gordon, MK; Overton, DA; Schmitt, MM; Wahl, MJ, 2002
)
2.01
"Prilocaine (Citanest) has been shown to be a satisfactory alternative to lignocaine, with certain important advantages, including superior diffusion. "( Peribulbar and retrobulbar anesthesia with prilocaine: a comparison of two methods of local ocular anesthesia.
Bourne, A; Morgan, LH; Pemberton, CJ; Saunders, DC; Sturgess, DA, 1993
)
1.99
"Prilocaine has recently been introduced for use in ocular local anaesthesia. "( Peribulbar anaesthesia for cataract surgery: prilocaine versus lignocaine and bupivacaine.
Franks, W; Henderson, TR, 1996
)
2
"Prilocaine has been described as causing less pain on injection than lidocaine with epinephrine, possibly because of the higher pH of the prilocaine anesthetic solution."( Pain on injection of prilocaine plain vs. lidocaine with epinephrine. A prospective double-blind study.
Howell, J; Muldoon, M; Overton, D; Schmitt, MM; Siegel, E; Wahl, MJ, 2001
)
2.07
"Prilocaine has become the agent of choice for Bier's block (or intravenous regional anaesthesia--IVRA), since 1983 when the product licence of bupivacaine was withdrawn for this purpose owing to fatal or serious complications. "( Prilocaine for Bier's block: how safe is safe?
Bartholomew, K; Sloan, JP, 1990
)
3.16

Actions

Prilocaine results in a lower incidence of transient neurological symptoms than lidocaine intrathecally. It is more suitable for short surgical procedures.

ExcerptReferenceRelevance
"Prilocaine can increase the fluidity of rat liver plasma membranes, as indicated by a fatty acid spin-probe. "( Glucagon-stimulated adenylate cyclase detects a selective perturbation of the inner half of the liver plasma-membrane bilayer achieved by the local anaesthetic prilocaine.
Dipple, I; Esgate, JA; Gordon, LM; Houslay, MD; Rawal, S; Sauerheber, RD, 1980
)
1.9
"Prilocaine results in a lower incidence of transient neurological symptoms than lidocaine intrathecally and therefore it is more suitable for short surgical procedures."( The incidence of transient neurological symptoms after spinal anaesthesia with lidocaine compared to prilocaine.
de Weert, K; Dirksen, R; Gielen, M; Slappendel, R; Traksel, M; Weber, E, 2000
)
1.24

Treatment

ExcerptReferenceRelevance
"Prilocaine treatment caused increased ROS/RNS formation and decreased TAC in heart and brain tissue."( Alleviation of prilocaine-induced epileptiform activity and cardiotoxicity by thymoquinone.
Afşar, E; Akgül, B; Aslan, M; Aycan, İÖ; Coşkunfırat, N; Hidişoğlu, E; Sanlı, S; Tanrıöver, G; Yıldırım, S, 2021
)
1.7

Toxicity

Lidocaine and prilocaine concentrations were below toxic levels; o-toluidine was not detected. The measured peak plasma concentration of lidocaine or prilOCaine did not reach toxic levels in any patient.

ExcerptReferenceRelevance
" We suggest that intravenous regional anaesthesia using prilocaine is a safe technique."( Prilocaine for Bier's block: how safe is safe?
Bartholomew, K; Sloan, JP, 1990
)
1.97
" Amide local anaesthetics are safe in MH-susceptible patients."( 3-in-1 lumbar plexus block for muscle biopsy in malignant hyperthermia patients. Amide local anaesthetics may be used safely.
Gielen, M; Viering, W, 1986
)
0.27
" Prilocaine proved to be significantly less toxic than bupivacaine."( [Toxicity of prilocaine and bupivacaine in intravenous regional anesthesia].
Hausmann, E; Tryba, M; Wellhöner, HH; Zenz, M, 1982
)
1.54
" 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
)
1.41
" The potential for toxic effects from such use has not been studied in a controlled manner."( Ocular toxicity following topical application of anesthetic cream to the eyelid skin.
Cohen, RG; Hartstein, M; Ladav, M; Lahav, M; Woog, JJ, 1996
)
0.29
" After 1 hour of treatment, the eyelid and anterior segment were examined for evidence of adverse reaction."( Ocular toxicity following topical application of anesthetic cream to the eyelid skin.
Cohen, RG; Hartstein, M; Ladav, M; Lahav, M; Woog, JJ, 1996
)
0.29
"No significant adverse effects were noted on external lid and anterior segment examination."( Ocular toxicity following topical application of anesthetic cream to the eyelid skin.
Cohen, RG; Hartstein, M; Ladav, M; Lahav, M; Woog, JJ, 1996
)
0.29
" The external application of EMLA cream may be safe in the periorbital region."( Ocular toxicity following topical application of anesthetic cream to the eyelid skin.
Cohen, RG; Hartstein, M; Ladav, M; Lahav, M; Woog, JJ, 1996
)
0.29
"Lidocaine-prilocaine cream is efficacious and safe for the prevention of pain from circumcision in neonates."( Efficacy and safety of lidocaine-prilocaine cream for pain during circumcision.
Ben-David, S; Craig, K; Koren, G; Mulligan, P; Rastogi, P; Shennan, A; Stevens, B; Taddio, A, 1997
)
0.98
"5 g lidocaine-prilocaine cream to the heel under occlusion four times a day during 30 min is safe in preterm neonates."( Safety of lidocaine-prilocaine cream application four times a day in premature neonates: a pilot study.
Essink-Tebbes, CM; Hekster, YA; Liem, KD; van Dongen, RT; Wuis, EW, 1999
)
0.99
" The authors conclude that EMLA is safe but not efficacious for relieving pain from heel lance in preterm infants."( Management of pain from heel lance with lidocaine-prilocaine (EMLA) cream: is it safe and efficacious in preterm infants?
Aranda, J; Jack, A; Johnston, C; Koren, G; Narciso, J; Stevens, B; Stremler, R; Taddio, A, 1999
)
0.56
" The measured peak plasma concentration of lidocaine or prilocaine did not reach toxic levels in any patient."( The efficacy and safety of EMLA cream for awake fiberoptic endotracheal intubation.
Afshar, M; Cypel, D; Goldberg, ME; Gratz, I; Larijani, GE; Mandel, R; Mroz, L, 2000
)
0.55
"We describe a 3-year-old child with mollusca contagiosa whose caregiver applied a eutectic mixture of 5% lidocaine and prilocaine (EMLA) in excessive amounts with the subsequent development of adverse reactions, including methemoglobinemia and hypoxemia."( Lidocaine and prilocaine toxicity in a patient receiving treatment for mollusca contagiosa.
Jackson, JB; Touma, S, 2001
)
0.88
" The studies selected had a sufficient number of geriatric and nongeriatric adults and a uniform, standardized pain stimulus (split-skin grafting), pain rating (visual analogue scale, verbal rating scale) and adverse event recording."( Split-skin grafting with lidocaine-prilocaine cream: A meta-analysis of efficacy and safety in geriatric versus nongeriatric patients.
Lillieborg, S; Wahlgren, CF, 2001
)
0.59
" Lidocaine and prilocaine concentrations were below toxic levels; o-toluidine was not detected."( Safety and pharmacokinetics of EMLA in the treatment of postburn pruritus in pediatric patients: a pilot study.
Bch, MB; Clarke, HM; Hubley, P; Jacobson, S; Kopecky, EA; Koren, G; Palozzi, L,
)
0.48
"Bier's block performed with prilocaine is at least as safe as other commonly used methods of anaesthesia for distal radial fracture reduction with high patient satisfaction."( Bier's block using prilocaine: safe, cheap and well tolerated.
Hunter, JB; Pickering, SA, 2003
)
0.94
"The pretreatment with nitrous oxide is a time effective and safe method for use at paediatric outpatient departments to reduce pain, facilitate venous cannulation, and thereby reduce the number of costly cancellations of planned procedures."( Nitrous oxide inhalation is a safe and effective way to facilitate procedures in paediatric outpatient departments.
Ekbom, K; Jakobsson, J; Marcus, C, 2005
)
0.33
" Neither anesthetic was systemically absorbed in any cat, and no adverse clinical signs were observed."( Adverse effects of EMLA (lidocaine/prilocaine) cream and efficacy for the placement of jugular catheters in hospitalized cats.
Gibbon, KJ; Kurian, JR; Strom, TL; Trepanier, LA; Wagner, KA, 2006
)
0.61
"General anesthesia produced physiological perturbations, exacerbated local anesthetic-induced cardiovascular depression, and changed the pharmacokinetics of toxic doses of local anesthetics."( The effects of general anesthesia on the central nervous and cardiovascular system toxicity of local anesthetics.
Copeland, SE; Gu, XQ; Ladd, LA; Mather, LE, 2008
)
0.35
"The use of a combined prilocaine/ ropivacaine (300 mg/75 mg) dose regimen in patients given single dose for brachial plexus blockade can generally be regarded as safe with regard to peak plasma concentrations and cardiovascular toxicity and this holds true for patients with a higher perioperative risk profile (ASA III grading, American Society of Anesthesiologists)."( Pharmacokinetics and clinical toxicity of prilocaine and ropivacaine following combined drug administration in brachial plexus anesthesia.
Huschak, G; Kaisers, UX; Meinecke, CD; Preiss, R; Regenthal, R; Rüffert, H; Taubert, MH; Wehner, M, 2009
)
0.93
" Adverse events were recorded."( Safety of lidocaine 15% and prilocaine 5% topical ointment used as local anesthesia for intense pulsed light treatment.
Carruthers, JA; Carruthers, JD; Mordaunt, J; Oliff, HS; Poirier, J; Schreiber, WE, 2010
)
0.65
" No adverse events related to systemic toxicity were observed or reported to the nurse."( Safety of lidocaine 15% and prilocaine 5% topical ointment used as local anesthesia for intense pulsed light treatment.
Carruthers, JA; Carruthers, JD; Mordaunt, J; Oliff, HS; Poirier, J; Schreiber, WE, 2010
)
0.65
"The development of safe and effective local anesthetic agents has possibly been the most important advancement in dental science to occur in the last century."( Local anesthetics: pharmacology and toxicity.
Hersh, EV; Moore, PA, 2010
)
0.36
"The study included data sets of annual sales of local anesthetics (from 1995 through 2007), 292 reports to the Danish Medicines Agency, Copenhagen, Denmark, of adverse reactions to local anesthetic drugs, and a clinical sample of 115 patients with NSD associated with local anesthetics."( Trigeminal nerve injury associated with injection of local anesthetics: needle lesion or neurotoxicity?
Ersbøll, BK; Hillerup, S; Jensen, RH, 2011
)
0.37
" A case/non-case study of spontaneous adverse events recorded in FAERS (FDA Adverse Event Reporting System) between 2004 and 2011 was performed."( Paraesthesia after local anaesthetics: an analysis of reports to the FDA Adverse Event Reporting System.
Gabusi, A; Gissi, DB; Montebugnoli, L; Piccinni, C; Poluzzi, E, 2015
)
0.42
"This case report describes a rare side effect during a Bier's block."( An uncommon side effect in a common procedure: a case report of an adverse reaction to prilocaine during a Bier's block.
Blau, C; Johnstone, R; Rooke, G, 2014
)
0.63
" While safe and well-tolerated when used appropriately, an overdose of these anesthetics increases the risk for local anesthetic systemic toxicity (LAST), which in severe cases can present with seizures, cardiac dysrhythmias, and ultimately cardiovascular collapse."( Local anesthetic systemic toxicity in the pediatric patient.
Baker, KA; McMahon, K; Paster, J, 2022
)
0.72
" Treatment-emergent adverse events occurred in 38."( Safety and Pharmacokinetics of PSD502 in Healthy Chinese Male and Female Volunteers: Two Randomized, Double-Blind, Placebo-Controlled, Phase I Trials.
Diao, L; Li, H; Liu, L; Liu, Z; Lu, J; Niu, X; Qi, L; Sun, Y; Wang, F; Wang, X; Zhao, L; Zhou, Y; Zhu, J, 2023
)
0.91

Pharmacokinetics

The aim of this study was to determine whether the addition of a small dose of prilocaine could augment the spinal block induced by meperidine. The tolerance and pharmacokinetic properties of mepivacaine and prilOCaine were compared following i.

ExcerptReferenceRelevance
"The aim of this study was to determine whether the addition of a small dose of prilocaine could augment the spinal block induced by meperidine and affect intrathecal meperidine pharmacokinetic behaviour."( Clinical and pharmacokinetic aspects of the combination of meperidine and prilocaine for spinal anaesthesia.
Bonnet, F; Hecquet, D; Houdek, MC; Maurette, P; Tauzin-Fin, P; Vincon, G, 1992
)
0.74
" However, the limiting dosages determined up to now do not take account of important pharmacokinetic and toxicological data: (1) The dependence of blood levels measured on the technique of regional anesthesia and (2) the raised toxicity of a local anesthetic solution containing adrenaline following inadvertent intravascular (intravenous) injection."( [Dose limits for local anesthetics. Recommendations based on toxicologic and pharmacokinetic data].
Kaiser, H; Niesel, HC, 1991
)
0.28
" Based upon a pharmacokinetic analysis of prilocaine serum concentrations after single-dose axillary plexus blockade in 14 patients, a pharmacokinetic model was established from which to predict serum concentrations after successive doses."( [The blood level and a pharmacokinetic model of prilocaine during a continuous brachial plexus blockade].
Lauven, PM; Lühr, HG; Lussi, C; Witow, R, 1990
)
0.8
" The present report describes our method and experience with this type of anesthesia in approximately 500 patients, including pharmacokinetic and -dynamic aspects."( [Intravenous regional anesthesia of the foot using prilocaine. Clinical aspects, pharmacokinetic and pharmacodynamic studies].
Bachmann-M, B; Biscoping, J; Hempelmann, G; Schürg, R, 1990
)
0.53
" pharmacokinetic data on 670 drugs representing, to our knowledge, the largest publicly available set of human clinical pharmacokinetic data."( Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
Lombardo, F; Obach, RS; Waters, NJ, 2008
)
0.35
" Plasma sample analysis was carried out by employing liquid chromatography coupled with tandem mass spectrometric (LC-MS/MS) method, and the pharmacokinetic analysis of the mouse plasma samples was estimated by standard non-compartmental methods."( A pharmacokinetic study of a topical anesthetic (EMLA® ) in mouse soft tissue laceration.
Al-Musawi, A; Andersson, L; Kombian, SB; Matar, K, 2012
)
0.38
" Nanorap pharmacodynamic (PD) and its physical proprieties were also evaluated."( Pharmacokinetic and pharmacodynamic evaluation of a nanotechnological topical formulation of lidocaine/prilocaine (nanorap) in healthy volunteers.
Arruda, AM; Castelli, MR; Chen, LS; Costa, SF; De Nucci, G; de Oliveira, MA; de Souza, W; Gagliano-Jucá, T; Lopes, AG; Mendes, GD, 2015
)
0.63

Compound-Compound Interactions

To compare pain control results between periprostatic nerve block alone and combined with topical prilocaine-lidocaine cream as local anesthesia of prostate biopsy. To investigate the effect of local usage of ıts combination with tramadol on the pain and anxiety levels of patients during nasal packing r.

ExcerptReferenceRelevance
" In this study they were evaluated the acute toxicity (lethal dose 50%, convulsion dose 50%) and latency times of loss of righting reflex and convulsion as well as the duration of convulsion) of 2% lidocaine or 3% prilocaine, when administered in combination with adrenaline and felypressin at various concentrations."( Acute toxicity (LD50 and CD50) of lidocaine and prilocaine in combination with adrenaline and felypressin.
Amaral, IM; Chalita, LV; Demetrio, CG; Ranali, J; Volpato, MC,
)
0.57
"To compare pain control results between periprostatic nerve block alone and combined with topical prilocaine-lidocaine cream as local anesthesia of prostate biopsy."( Topical prilocaine-lidocaine cream combined with peripheral nerve block improves pain control in prostatic biopsy: results from a prospective randomized trial.
Briganti, A; Dehò, F; Di Girolamo, V; Gallina, A; Montorsi, F; Raber, M; Rigatti, P; Roscigno, M; Salonia, A; Scattoni, V, 2008
)
1
"Three hundred patients were randomized to receive PNB (group 1), topical anesthesia of the anal ring, anal canal, and anterior rectal wall combined with PNB (group 2) and placebo (group 3)."( Topical prilocaine-lidocaine cream combined with peripheral nerve block improves pain control in prostatic biopsy: results from a prospective randomized trial.
Briganti, A; Dehò, F; Di Girolamo, V; Gallina, A; Montorsi, F; Raber, M; Rigatti, P; Roscigno, M; Salonia, A; Scattoni, V, 2008
)
0.78
"Results of a prospective, randomized, double-blinded study about tumescent anaesthesia (TA) in combination with femoral nerve block (FNB) for surgery of varicose veins are reported."( Tumescent anaesthesia in combination with femoral nerve block for surgery of varicose veins: prilocaine 0.1% versus 0.2%.
Dullenkopf, A; Hillermann, T; Joechle, W; Traber, J, 2011
)
0.59
"1% in combination with FNB is sufficient to provide high patient satisfaction during varicosis surgery."( Tumescent anaesthesia in combination with femoral nerve block for surgery of varicose veins: prilocaine 0.1% versus 0.2%.
Dullenkopf, A; Hillermann, T; Joechle, W; Traber, J, 2011
)
0.59
" This study aimed to demonstrate the efficacy and safety of three intrarectal local anesthesia (IRLA) combined with PPNB in patients undergoing transrectal ultrasonography (TRUS)-guided prostate biopsy."( Prospective comparison among three intrarectal anesthetic treatments combined with periprostatic nerve block during transrectal ultrasonography-guided prostate biopsy.
Campos-Salcedo, JG; Canizalez-Román, A; Parés-Hipólito, J; Sedano-Lozano, A; Shelton, LM; Torres-Gomez, JJ; Valdez-Flores, MA; Valdez-Flores, RA, 2018
)
0.48
"Intrarectal application of EMLA cream is a more efficient pain reduction than either 2% lidocaine gel or 100 mg indomethacin suppository when applied combined with PPNB."( Prospective comparison among three intrarectal anesthetic treatments combined with periprostatic nerve block during transrectal ultrasonography-guided prostate biopsy.
Campos-Salcedo, JG; Canizalez-Román, A; Parés-Hipólito, J; Sedano-Lozano, A; Shelton, LM; Torres-Gomez, JJ; Valdez-Flores, MA; Valdez-Flores, RA, 2018
)
0.48
"To investigate the effect of local usage of prilocaine and ıts combination with tramadol on the pain and anxiety levels of patients during nasal packing removal."( Effect of prilocaine and its combination with tramadol on anxiety and pain during nasal packing removal.
Arslan, E; Tulaci, KG; Tulaci, RG; Yazici, H, 2020
)
1.22
" Patients whose Merocel nasal packings infiltrated with prilocaine (P group), prilocaine combined with tramadol 1 mg/kg (P + T1 group), prilocaine combined with tramadol 2 mg/kg (P + T2 group), or normal saline solution (Control group) before nasal packing removal were compared for their pain, sedation, and anxiety related to this removal procedure."( Effect of prilocaine and its combination with tramadol on anxiety and pain during nasal packing removal.
Arslan, E; Tulaci, KG; Tulaci, RG; Yazici, H, 2020
)
1.21
" We speculated that the application of compound lidocaine/prilocaine combined with tetracaine spray would better prevent coughing caused by tracheal extubation."( Compound lidocaine/prilocaine cream combined with tetracaine prevents cough caused by extubation after general anaesthesia: a randomised controlled trial.
Gao, J; Li, T; Li, Y; Wang, M; Zhang, E; Zhang, H; Zhang, L; Zhao, X, 2023
)
1.48
"Patients scheduled for laparoscopic cholecystectomy or cholecystectomy combined with common bile duct exploration under general anaesthesia were randomly assigned to Group C (saline spray), Group L (2 g compound lidocaine/prilocaine cream contains 5 mg of lidocaine and 5 mg prilocaine)), Group T (tetracaine) and Group F (compound lidocaine/prilocaine cream combined with tetracaine)."( Compound lidocaine/prilocaine cream combined with tetracaine prevents cough caused by extubation after general anaesthesia: a randomised controlled trial.
Gao, J; Li, T; Li, Y; Wang, M; Zhang, E; Zhang, H; Zhang, L; Zhao, X, 2023
)
1.42
"Compound lidocaine/prilocaine cream combined with tetracaine may be a more effective approach for preventing coughing and stabilising circulation during extubation following general anaesthesia."( Compound lidocaine/prilocaine cream combined with tetracaine prevents cough caused by extubation after general anaesthesia: a randomised controlled trial.
Gao, J; Li, T; Li, Y; Wang, M; Zhang, E; Zhang, H; Zhang, L; Zhao, X, 2023
)
1.57

Bioavailability

ExcerptReferenceRelevance
" We studied bioavailability and changes in methemoglobin levels following topical penile exposure to 1 g of EMLA cream for 1 hour in piglets."( Penile absorption of EMLA cream in piglets: implications for use of EMLA in neonatal circumcision.
Gazarian, M; Kent, G; Klein, J; Koren, G; Taddio, A, 1995
)
0.29
" Addition of clonidine to the formulations decreased the systemic absorption rate of the anesthetics from the patch application site without impacting the coating performance or the rapid onset of anesthesia."( Adjuvants to prolong the local anesthetic effects of coated microneedle products.
Brown, K; Dohmeier, D; Hansen, K; Siebenaler, K; Zhang, Y, 2012
)
0.38
"Over the past decade, the formation of pharmaceutical eutectics has become a very attractive strategy to increase the bioavailability of active pharmaceutical ingredients (APIs)."( The effect of electrostatic interactions on the formation of pharmaceutical eutectics.
Knapik-Kowalczuk, J; Paluch, M; Sherif, A; Smolka, W; Tajber, L; Wojnarowska, Z; Zotova, J, 2018
)
0.48

Dosage Studied

The objective of the study was to investigate the clinical effectiveness of increasing the dosage of prilocaine for a combined 3-in-1/sciatic nerve block from 500 to 650 mg. Neither the higher toxicity to the central nervous and cardiovascular systems from mepivacaine, nor the methemoglobin formed by prilOCaine seems to be of clinical significance with the dosage and technique employed.

ExcerptRelevanceReference
" The efficacy of the sciatic block proved to be extremely high (> 95%), its success depending on the dosage of the local anaesthetic and correct execution of the peripheral nerve stimulation."( Prilocaine in lumbosacral plexus block--general efficacy and comparison of nerve stimulation amplitude.
Bodenmueller, M; Kaiser, H; Klimpel, L; Niesel, HC, 1992
)
1.73
" Neither the higher toxicity to the central nervous and cardiovascular systems from mepivacaine, nor the methemoglobin formed by prilocaine seems to be of clinical significance with the dosage and technique employed."( [Comparative study of 1% prilocaine and 1% mepivacaine in axillary plexus anesthesia].
Büttner, J; Dreesen, H; Klose, R, 1987
)
0.78
" The development of anaesthesia was fastest following the largest dose, but the large number of central side effects makes that dosage less suitable for clinical work."( Intravenous regional anaesthesia below the knee. A cross-over study with prilocaine in volunteers.
Rosenberg, PH; Valli, H, 1986
)
0.5
" 3 The log dose-response curve for the contractile response of longitudinal muscle strips from guinea-pig intestine to carbachol was shifted in a parallel fashion by low concentrations of tetracaine, but flattened by higher doses."( The interaction of amine local anaesthetics with muscarinic receptors.
Taylor, WJ; Wolf, A; Young, JM, 1980
)
0.26
" We conclude that morphine is clinically effective in the peripheral nervous system at this dosage range."( Morphine/prilocaine combination for intravenous regional anesthesia.
Aktürk, G; Dohman, D; Erciyes, N; Solak, M, 1995
)
0.71
" Combining these observations with local anesthetic dosage considerations, the authors recommend that 2 percent lido-epi be used when performing mandibular block injections in young children."( Assessing the duration of mandibular soft tissue anesthesia.
Hermann, DG; Hersh, EV; Johnson, PD; Lamp, CJ; MacAfee, KA, 1995
)
0.29
" It cannot replace the need for analgesic sedation but it can be used advantageously to reduce the dosage of analgesic and sedative drugs during ESWL treatments performed without regional or general anesthesia in the unmodified Dornier HM3 lithotriptor."( Cutaneous anesthesia with lidocaine-prilocaine cream: a useful adjunct during shock wave lithotripsy with analgesic sedation.
Tiselius, HG, 1993
)
0.56
"The objective of the study was to investigate the clinical effectiveness of increasing the dosage of prilocaine for a combined 3-in-1/sciatic nerve block from 500 to 650 mg (open study with 29 patients compared with 30 patients from a former study) and to validate these findings in a second stage (randomised study comparing two groups of 30 patients each)."( [Combined 3-in-1 sciatic block. Prilocaine 500 mg vs. 650 mg].
Missler, B; Wagner, F, 1997
)
0.8
" Physicians must adhere to recommendations to avoid mucous membrane contact and ensure appropriate dosing with these agents."( Topical anesthesia.
Keyes, PD; Rizos, J; Tallon, JM, 1998
)
0.3
" They also should follow new recommended dosing guidelines for prilocaine and be aware of symptoms of this adverse reaction."( When patients become cyanotic: acquired methemoglobinemia.
Lloyd, LM; Wilburn-Goo, D, 1999
)
0.54
"Data abstracted from each report included gestational age at birth, timing and dosage regimen of EMLA, control group treatment and outcomes."( Lidocaine-prilocaine cream for analgesia during circumcision in newborn boys.
Ohlsson, A; Ohlsson, K; Taddio, A, 2000
)
0.71
" It was concluded that articaine showed quicker onset than lidocaine and propitocaine and that there was a need to increase the dosage to attain a quick onset or to extend the duration."( Comparative study on anesthetic potency of dental local anesthetics assessed by the jaw-opening reflex in rabbits.
Aida, H; Kaneko, Y; Miyoshi, T, 2000
)
0.31
" The assays were shown to be suitable for measuring epinephrine-prilocaine and epinephrine-procaine combinations in their respective injection dosage forms."( Stability-indicating HPLC assays for the determination of prilocaine and procaine drug combinations.
Stewart, JT; Storms, ML, 2002
)
0.8
" Dosage had no significant effect."( Role of histamine release in nonspecific vasodilatation during anodal and cathodal iontophoresis.
Droog, EJ; Henricson, J; Horiuchi, Y; Lennquist, S; Sjöberg, F; Wikström, T, 2004
)
0.32
" In groups 6 and 7, additional fentanyl doses were lower than in the other groups, but only in group 7 was the total fentanyl dosage low."( Effectiveness of eutectic mixture of local anesthetic cream and occlusive dressing with low dosage of fentanyl for pain control during shockwave lithotripsy.
Basar, H; Basar, MM; Batislam, E; Ozcan, S; Tuglu, D; Yilmaz, E, 2005
)
0.33
" The requested frequency and dosage of meperidine, the first spontaneous voiding time, the frequency of single urinary catheterization, and a patient satisfaction score were also obtained."( Use of a topical anesthetic cream (EMLA) to reduce pain after hemorrhoidectomy.
Chen, HS; Hung, KC; Lin, SE; Shiau, JM; Su, HP; Tseng, CC,
)
0.13
"The VAS score and frequency and dosage of meperidine injections were significantly lower in the EMLA group than in the control group (P < ."( Use of a topical anesthetic cream (EMLA) to reduce pain after hemorrhoidectomy.
Chen, HS; Hung, KC; Lin, SE; Shiau, JM; Su, HP; Tseng, CC,
)
0.13
" The aim of this prospective, single-centre, randomised, single-blinded, controlled clinical trial was to determine the optimal dosage of hyperbaric prilocaine 20 mg/ml for a spinal anaesthesia (SPA) in patients undergoing perianal outpatient surgery."( Dosage finding for low-dose spinal anaesthesia using hyperbaric prilocaine in patients undergoing perianal outpatient surgery.
Gebhardt, V; Herold, A; Samakas, A; Schmittner, MD; Weiss, C, 2013
)
0.83
" (4) Cutaneous sensory blockade does not appear to alter nitric oxide-mediated vasodilation, adrenergic vasoconstriction, or cholinergic eccrine sweating dose-response sensitivity or responsiveness to maximal dose."( Topical anaesthesia does not affect cutaneous vasomotor or sudomotor responses in human skin.
Metzler-Wilson, K; Wilson, TE, 2013
)
0.39
" The optimized microemulsion systems in gel dosage forms revealed the better permeability over commercial cream (CC) through abdominal rat skin."( Phospholipid microemulsion-based hydrogel for enhanced topical delivery of lidocaine and prilocaine: QbD-based development and evaluation.
Beg, S; Katare, OP; Negi, P; Raza, K; Sharma, G; Singh, B, 2016
)
0.66
" All 12 clinical trials evaluating the safety of EMLA in either the pediatric or adult population generally followed dosing and administration guidelines set by the manufacturer and reported clinically insignificant plasma levels of methemoglobin, lidocaine, prilocaine, and their respective metabolites."( Risk of systemic toxicity with topical lidocaine/prilocaine: a review.
Koo, JY; Tran, AN, 2014
)
0.84
" Despite this, an ideal approach and dosing regimen for cervical plexus block remain elusive."( Ropivacaine 0.375% vs. 0.75% with prilocaine for intermediate cervical plexus block for carotid endarterectomy: A randomised trial.
Felder, TK; Gerner, P; Koköfer, A; Mader, N; Nawratil, J; Stundner, O, 2015
)
0.7
"Study selection All included studies were randomised controlled trials comparing different agents, different dosage or different concentration of local anaesthetics in clinical procedures or simulated scenarios using parallel or cross-over design with no language or year of publication restrictions."( Injectable local anaesthetic agents for dental anaesthesia.
Spivakovsky, S, 2019
)
0.51
" Timing and dosing of the drug can deserve to be adjusted according to patient's needs and their sexual ecology."( Real-life use of the eutectic mixture lidocaine/prilocaine spray in men with premature ejaculation.
Boeri, L; Fallara, G; Montorsi, F; Pozzi, E; Salonia, A, 2022
)
0.98
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Roles (2)

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.
anticonvulsantA drug used to prevent seizures or reduce their severity.
[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
amino acid amideAn amide of an amino acid formed formally by conversion of the carboxy group to a carboxamido group.
monocarboxylic acid amideA carboxamide derived from a monocarboxylic acid.
[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
Prilocaine Action Pathway3111

Protein Targets (4)

Potency Measurements

ProteinTaxonomyMeasurementAverage (µ)Min (ref.)Avg (ref.)Max (ref.)Bioassay(s)
cytochrome P450 2D6Homo sapiens (human)Potency37.90830.00108.379861.1304AID1645840
arylsulfatase AHomo sapiens (human)Potency0.30131.069113.955137.9330AID720538
euchromatic histone-lysine N-methyltransferase 2Homo sapiens (human)Potency1.06210.035520.977089.1251AID504332
chromobox protein homolog 1Homo sapiens (human)Potency31.62280.006026.168889.1251AID488953
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Bioassays (41)

Assay IDTitleYearJournalArticle
AID588378qHTS for Inhibitors of ATXN expression: Validation
AID1347082qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lassa (LASV) Arenavirus: LASV Primary Screen - GLuc reporter signal2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID504810Antagonists of the Thyroid Stimulating Hormone Receptor: HTS campaign2010Endocrinology, Jul, Volume: 151, Issue:7
A small molecule inverse agonist for the human thyroid-stimulating hormone receptor.
AID1347410qHTS for inhibitors of adenylyl cyclases using a fission yeast platform: a pilot screen against the NCATS LOPAC library2019Cellular signalling, 08, Volume: 60A fission yeast platform for heterologous expression of mammalian adenylyl cyclases and high throughput screening.
AID1347058CD47-SIRPalpha protein protein interaction - HTRF assay qHTS validation2019PloS one, , Volume: 14, Issue:7
Quantitative high-throughput screening assays for the discovery and development of SIRPα-CD47 interaction inhibitors.
AID588349qHTS for Inhibitors of ATXN expression: Validation of Cytotoxic Assay
AID504836Inducers of the Endoplasmic Reticulum Stress Response (ERSR) in human glioma: Validation2002The Journal of biological chemistry, Apr-19, Volume: 277, Issue:16
Sustained ER Ca2+ depletion suppresses protein synthesis and induces activation-enhanced cell death in mast cells.
AID1347057CD47-SIRPalpha protein protein interaction - LANCE assay qHTS validation2019PloS one, , Volume: 14, Issue:7
Quantitative high-throughput screening assays for the discovery and development of SIRPα-CD47 interaction inhibitors.
AID1347059CD47-SIRPalpha protein protein interaction - Alpha assay qHTS validation2019PloS one, , Volume: 14, Issue:7
Quantitative high-throughput screening assays for the discovery and development of SIRPα-CD47 interaction inhibitors.
AID1508630Primary qHTS for small molecule stabilizers of the endoplasmic reticulum resident proteome: Secreted ER Calcium Modulated Protein (SERCaMP) assay2021Cell reports, 04-27, Volume: 35, Issue:4
A target-agnostic screen identifies approved drugs to stabilize the endoplasmic reticulum-resident proteome.
AID504812Inverse Agonists of the Thyroid Stimulating Hormone Receptor: HTS campaign2010Endocrinology, Jul, Volume: 151, Issue:7
A small molecule inverse agonist for the human thyroid-stimulating hormone receptor.
AID1347049Natriuretic polypeptide receptor (hNpr1) antagonism - Pilot screen2019Science translational medicine, 07-10, Volume: 11, Issue:500
Inhibition of natriuretic peptide receptor 1 reduces itch in mice.
AID1347045Natriuretic polypeptide receptor (hNpr1) antagonism - Pilot counterscreen GloSensor control cell line2019Science translational medicine, 07-10, Volume: 11, Issue:500
Inhibition of natriuretic peptide receptor 1 reduces itch in mice.
AID1347405qHTS to identify inhibitors of the type 1 interferon - major histocompatibility complex class I in skeletal muscle: primary screen against the NCATS LOPAC collection2020ACS chemical biology, 07-17, Volume: 15, Issue:7
High-Throughput Screening to Identify Inhibitors of the Type I Interferon-Major Histocompatibility Complex Class I Pathway in Skeletal Muscle.
AID1347086qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lymphocytic Choriomeningitis Arenaviruses (LCMV): LCMV Primary Screen - GLuc reporter signal2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1347151Optimization of GU AMC qHTS for Zika virus inhibitors: Unlinked NS2B-NS3 protease assay2020Proceedings of the National Academy of Sciences of the United States of America, 12-08, Volume: 117, Issue:49
Therapeutic candidates for the Zika virus identified by a high-throughput screen for Zika protease inhibitors.
AID1347083qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lassa (LASV) Arenavirus: Viability assay - alamar blue signal for LASV Primary Screen2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1347050Natriuretic polypeptide receptor (hNpr2) antagonism - Pilot subtype selectivity assay2019Science translational medicine, 07-10, Volume: 11, Issue:500
Inhibition of natriuretic peptide receptor 1 reduces itch in mice.
AID350218Octanol-water partition coefficient, log PC of the compound2009Journal of medicinal chemistry, May-28, Volume: 52, Issue:10
Lipophilicity of basic drugs measured by hydrophilic interaction chromatography.
AID540213Half life in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID540209Volume of distribution at steady state in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID540210Clearance in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID350219Lipophilicity, log K at pH 2 by by hydrophilic interaction chromatography using 95% acetonitrile as mobile phase2009Journal of medicinal chemistry, May-28, Volume: 52, Issue:10
Lipophilicity of basic drugs measured by hydrophilic interaction chromatography.
AID350216Dissociation constant, pKa of the compound2009Journal of medicinal chemistry, May-28, Volume: 52, Issue:10
Lipophilicity of basic drugs measured by hydrophilic interaction chromatography.
AID540211Fraction unbound in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID467612Fraction unbound in human plasma2009European journal of medicinal chemistry, Nov, Volume: 44, Issue:11
Prediction of volume of distribution values in human using immobilized artificial membrane partitioning coefficients, the fraction of compound ionized and plasma protein binding data.
AID205267Inhibition of binding of Batrachotoxinin [3H]BTX-B to high affinity sites on voltage dependent sodium channels in a vesicular preparation from guinea pig cerebral cortex1985Journal of medicinal chemistry, Mar, Volume: 28, Issue:3
[3H]Batrachotoxinin A 20 alpha-benzoate binding to voltage-sensitive sodium channels: a rapid and quantitative assay for local anesthetic activity in a variety of drugs.
AID409953Inhibition of mouse liver MAOA2008Journal of medicinal chemistry, Nov-13, Volume: 51, Issue:21
Quantitative structure-activity relationship and complex network approach to monoamine oxidase A and B inhibitors.
AID312896Partition coefficient, log P by UPLC method2008Journal of medicinal chemistry, Feb-14, Volume: 51, Issue:3
High-throughput log P determination by ultraperformance liquid chromatography: a convenient tool for medicinal chemists.
AID467613Volume of distribution at steady state in human2009European journal of medicinal chemistry, Nov, Volume: 44, Issue:11
Prediction of volume of distribution values in human using immobilized artificial membrane partitioning coefficients, the fraction of compound ionized and plasma protein binding data.
AID467611Dissociation constant, pKa of the compound2009European journal of medicinal chemistry, Nov, Volume: 44, Issue:11
Prediction of volume of distribution values in human using immobilized artificial membrane partitioning coefficients, the fraction of compound ionized and plasma protein binding data.
AID205269Inhibition of binding of Batrachotoxinin [3H]BTX-B to high-affinity sites on voltage-dependent sodium channels in a vesicular preparation from guinea pig cerebral cortex at 100 uM1985Journal of medicinal chemistry, Mar, Volume: 28, Issue:3
[3H]Batrachotoxinin A 20 alpha-benzoate binding to voltage-sensitive sodium channels: a rapid and quantitative assay for local anesthetic activity in a variety of drugs.
AID450273Lipophilicity, log P of the compound2009Bioorganic & medicinal chemistry, Oct-01, Volume: 17, Issue:19
Ligand-based design and synthesis of novel sodium channel blockers from a combined phenytoin-lidocaine pharmacophore.
AID450269Displacement of [3H]-BTX-B from neuronal voltage-gated sodium channel in rat cerebral cortex synaptoneurosomes2009Bioorganic & medicinal chemistry, Oct-01, Volume: 17, Issue:19
Ligand-based design and synthesis of novel sodium channel blockers from a combined phenytoin-lidocaine pharmacophore.
AID205268Inhibition of binding of Batrachotoxinin [3H]BTX-B to high affinity sites on voltage dependent sodium channels in a vesicular preparation from guinea pig cerebral cortex at 10 uM1985Journal of medicinal chemistry, Mar, Volume: 28, Issue:3
[3H]Batrachotoxinin A 20 alpha-benzoate binding to voltage-sensitive sodium channels: a rapid and quantitative assay for local anesthetic activity in a variety of drugs.
AID540212Mean residence time in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID350220Lipophilicity, log K at pH 2 by by hydrophilic interaction chromatography using 100% water as mobile phase2009Journal of medicinal chemistry, May-28, Volume: 52, Issue:10
Lipophilicity of basic drugs measured by hydrophilic interaction chromatography.
AID1061889Displacement of [3H]BTX-B from neuronal voltage-gated sodium channel in rat cerebral cortex synaptoneurosomes after 60 mins by scintillation counting2014Bioorganic & medicinal chemistry, Jan-01, Volume: 22, Issue:1
A highly predictive 3D-QSAR model for binding to the voltage-gated sodium channel: design of potent new ligands.
AID312895Partition coefficient, log P of the compound2008Journal of medicinal chemistry, Feb-14, Volume: 51, Issue:3
High-throughput log P determination by ultraperformance liquid chromatography: a convenient tool for medicinal chemists.
AID409954Inhibition of mouse brain MAOA2008Journal of medicinal chemistry, Nov-13, Volume: 51, Issue:21
Quantitative structure-activity relationship and complex network approach to monoamine oxidase A and B inhibitors.
AID1159607Screen for inhibitors of RMI FANCM (MM2) intereaction2016Journal of biomolecular screening, Jul, Volume: 21, Issue:6
A High-Throughput Screening Strategy to Identify Protein-Protein Interaction Inhibitors That Block the Fanconi Anemia DNA Repair Pathway.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (2,000)

TimeframeStudies, This Drug (%)All Drugs %
pre-1990466 (23.30)18.7374
1990's599 (29.95)18.2507
2000's518 (25.90)29.6817
2010's341 (17.05)24.3611
2020's76 (3.80)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 53.57

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 Index53.57 (24.57)
Research Supply Index8.00 (2.92)
Research Growth Index4.50 (4.65)
Search Engine Demand Index138.39 (26.88)
Search Engine Supply Index2.98 (0.95)

This Compound (53.57)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials770 (34.95%)5.53%
Reviews130 (5.90%)6.00%
Case Studies222 (10.08%)4.05%
Observational3 (0.14%)0.25%
Other1,078 (48.93%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (101)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Efficacy and Safety of Prilocaine 2% and Lidocaine 5% Hyperbaric Against Spinal Anesthesia in Post Cystoscopy Procedure [NCT05834647]Phase 445 participants (Anticipated)Interventional2023-08-01Not yet recruiting
Lidocaine-Prilocaine (EMLA) Cream as Analgesia in Hysterosalpingography Practice: a Prospective Randomized Double Blind, Placebo-controlled Clinical Trial [NCT01303614]Phase 4100 participants (Anticipated)Interventional2011-04-30Not yet recruiting
A Comparison of the Efficacy of Ablative Fractional Laser-assisted Photodynamic Therapy According to the Density of Ablative Laser Channel in the Treatment of Actinic Keratosis [NCT03731988]Phase 447 participants (Actual)Interventional2017-02-01Completed
Ultrasound-guided Shoulder PENG Block Versus Suprascapular Nerve Block for Postoperative Analgesia in Shoulder Arthroscopy; A Prospective Randomized Controlled Study [NCT05666076]74 participants (Anticipated)Interventional2022-11-14Recruiting
The Effect of Lidocaine - Prilocaine Cream (EMLA) Versus Mepivacaine Infiltration on Pain Relief During And After Mediolateral Episiotomies: A Randomized Clinical Trial [NCT03264586]Phase 4200 participants (Anticipated)Interventional2017-08-31Not yet recruiting
A Double-Blind, Randomized, Placebo-Controlled Trial of Eutectic Lidocaine/Prilocaine Cream 5% (EMLA) for Analgesia Prior to Cryotherapy of Verrucae Plantaris in Adults [NCT01330615]64 participants (Anticipated)Interventional2010-02-28Recruiting
Estimation of the Effective Dose (ED) 95 of Intrathecal Hyperbaric Prilocaine 2% for Scheduled Cesarean Delivery : a Dose-finding Study Based on the Continual Reassessment. [NCT03607916]Phase 240 participants (Actual)Interventional2014-02-28Completed
Hyperbaric Bupivacaine Versus Hyperbaric Prilocaine 2% for Cesarean Section Under Spinal Anesthesia: a Randomised Clinical Trial [NCT02973048]Phase 340 participants (Actual)Interventional2018-03-12Completed
Topical Anesthesia Versus Placebo to Decrease Post Procedure Pain in Rubber Band Ligation for the Treatment of Grade I - III Symptomatic Internal Hemorrhoids. A Single Institution, Double Blinded, Placebo Controlled Trial. [NCT02130830]Phase 380 participants (Actual)Interventional2014-05-31Completed
Cardiovascular Effects of Intrathecal Hyperbaric Prilocaine or Bupivacaine in Surgery Under Spinal Anesthesia: A Multicenter Prospective Pilot Study Based on Non- Invasive Haemodynamic Monitoring [NCT05751148]60 participants (Anticipated)Interventional2023-03-22Recruiting
A Double Blind Randomized Controlled Trial Comparing the Efficacy of 7% Lidocaine / 7% Tetracaine Cream Versus 2,5% Lidocaine / 2,5% Prilocaine Cream for Local Anaesthesia During Laser Treatment of Acne Keloidalis Nuchae and Tattoo Removal [NCT02372786]Phase 430 participants (Actual)Interventional2014-11-30Completed
An Exploratory Pilot Study in Healthy Volunteers to Assess the Parameters for the Design of Bioequivalence Studies on Moderately Lipophilic, Moderately to Highly Protein Bound Drugs Using Dermal Open Flow Microperfusion (dOFM) [NCT03613207]6 participants (Actual)Interventional2018-03-22Completed
Effect of Topical Lidocaine-prilocaine Cream Versus Rectal Meloxicam Suppository on Relief of Post-episiotomy Pain: A Randomized Clinical Trial [NCT03146000]Phase 3190 participants (Actual)Interventional2017-05-01Completed
Lidocaine Versus Ketorolac for the Management of Renal Colic [NCT03137498]Phase 460 participants (Anticipated)Interventional2017-03-06Recruiting
Understanding Rebound Pain After Regional Anesthesia Resolution: Mechanistic Trial in Healthy Volunteers [NCT06005480]Phase 140 participants (Anticipated)Interventional2023-09-30Not yet recruiting
Comparison of the Analgesic Effects of Oblique Subcostal, Posterior or Dual Transversus Abdominis Plane (TAP) Block in Patients Undergoing Laparoscopic Cholecystectomy [NCT04693156]71 participants (Actual)Interventional2021-02-01Completed
Diminishing Accelerated Long-term Forgetting in Mild Cognitive Impairment: Study Protocol for a Prospective, Double-blind, Placebo-controlled, Randomized Controlled Trial [NCT05289804]Phase 1/Phase 2100 participants (Anticipated)Interventional2022-09-01Recruiting
Clinical Use of Prilocaine Chlorhydrate Among a General Surgical Population [NCT02282280]380 participants (Actual)Observational2014-10-31Completed
Lidocaine/Tetracaine Patch (Ralydan) vs Lidocaine/Prilocaine Cream (EMLA) for Needle Related Procedures in Children: a Multicenter, Randomized Controlled Trial [NCT02519660]Phase 3339 participants (Actual)Interventional2015-04-30Completed
Lidocaine-Prilocaine (EMLA) Cream as Analgesia in Hysteroscopy Practice: a Prospective Randomized Clinical Trial [NCT01094015]Phase 492 participants (Actual)Interventional2007-07-31Completed
Comparison of Hyperbaric Prilocaine 2% 50 Mg and Hyperbaric Bupivacaine 0.5% 12.5 Mg Against Spinal Anesthesia Recovery Time in Cystoscopy Procedure [NCT05610007]Phase 466 participants (Actual)Interventional2022-01-01Active, not recruiting
Lidocaine-Prilocaine Cream in Conjunction With Lidocaine Paracervical Block for Pain With First-Trimester Abortion: A Double-Blind Randomized Controlled Trial [NCT03508804]Phase 30 participants (Actual)Interventional2020-12-31Withdrawn(stopped due to Lack of funding.)
Emla-Cream as Pain Relief During Pneumococcal Vaccination [NCT01802086]72 participants (Actual)Interventional2013-05-31Completed
Hybrid Anesthesia for Ambulatory Knee Arthroscopy Using Intrathecal Prilocaine and Adductor Canal Block vs Intrathecal Bupivacaine Alone: a Randomized Controlled Trial [NCT05609565]Phase 480 participants (Anticipated)Interventional2022-11-15Recruiting
An Open-Label Study Of The Use Of Topical Lidocaine (2.5%)/Prilocaine (2.5%) Cream As Pre-Treatment For NGX-4010 In Subjects With Postherpetic Neuralgia (PHN) [NCT00916942]Phase 220 participants (Anticipated)Interventional2009-06-30Completed
Evaluation of the Analgesy Using a Local Anesthetic (Lidocaine and Prolocaine) Eutectic Mixture and/or Nitric Oxide at 50% in Oxygen (Livopan®) in Pediatric Patients That During Lumbar Puncture [NCT00808171]Phase 452 participants (Actual)Interventional2009-02-28Completed
Selective Spinal Anesthesia Using Hyperbaric Prilocaine 2% Provides Better Perioperative Hemodynamic Stability for Patients With Peripheral Vascular Disease and Cardiac Dysfunction Undergoing Lower Limb Vascular Surgery [NCT05877690]80 participants (Anticipated)Interventional2023-10-31Recruiting
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
Prospective Analgesic Compound Efficacy (PACE) Study [NCT02403687]300 participants (Actual)Observational [Patient Registry]2015-06-30Completed
Fractional Carbon Dioxide Laser Assisted Delivery of Topical Anesthetics: a Randomized Controlled Pilot Study [NCT02246179]Phase 410 participants (Actual)Interventional2014-09-30Completed
Efficacy in Ablative Fractional Laser Assisted Photodynamic Therapy According to Ablative Depth for Actinic Keratosis [NCT03325803]Phase 145 participants (Actual)Interventional2015-09-01Completed
A Randomized Comparative Study on the Effect of Using Intrathecal Hyperbaric Prilocaine Plus Fentanyl Compared to Hyperbaric Bupivacaine Plus Fentanyl on the Motor Block in Women Undergoing Caesarean Section Under Spinal Anesthesia [NCT06133881]Phase 440 participants (Anticipated)Interventional2023-12-01Not yet recruiting
Efficacy of Inhaled 50% Equimolar Nitrous Oxide/Oxygen Gas Premix (Kalinox®) as Compared to Topically Administered 5% Eutectic Mixture of Lidocaine/Prilocaine (EMLA®) in Chronic Leg Ulcer Debridement [NCT02696460]21 participants (Actual)Interventional2010-04-30Completed
Comparing Combined Adductor Canal & Sciatic Nerve Block and Femoral & Sciatic Nerve Block for Postoperative Analgesia in Patients Undergoing Total Knee Replacement Surgery; A Prospective, Randomized, Controlled Study [NCT05648708]68 participants (Anticipated)Interventional2022-11-14Recruiting
A Randomised Trial Comparing Methyl Aminolaevulinate Photodynamic Therapy With and Without Ablative Fractional Laser Treatment in Patients With Microinvasive Squamous Cell Carcinoma: Results From a 24-month Follow-up [NCT02666534]Phase 145 participants (Actual)Interventional2012-01-31Completed
Effect of Cervical Lidocaine-prilocaine Cream on IUD Insertion Pain: A Randomized Controlled Trial [NCT02658773]Phase 2120 participants (Actual)Interventional2016-01-31Completed
An Exploratory Study in Healthy Volunteers to Identify Factors Influencing Bioequivalence Studies on Moderately Lipophilic Drugs Using Dermal Open Flow Microperfusion (dOFM) [NCT04050826]20 participants (Actual)Interventional2019-09-01Completed
Evaluation of Analgesia With the Use of Eutectic Mixture of Local Anesthetics (Lidocaine and Prilocaine) and Oral Solution of Glucose to 25% in Preterm Neonates During Arterial Puncture and / or the Installation of Percutaneous Catheter [NCT00808054]Phase 460 participants (Actual)Interventional2008-11-30Completed
Detecting Compartment Syndrome Pain in the Presence of Regional Anesthesia in Healthy Volunteers [NCT04113954]Phase 142 participants (Actual)Interventional2020-09-29Completed
Efficacy of Iontophoresis-assisted Ablative Fractional Laser Photodynamic Therapy With Short Incubation Time for the Treatment of Actinic Keratosis: 12-month Follow-up Results of a Prospective, Randomised, Comparative Trial [NCT02670655]Phase 145 participants (Actual)Interventional2014-06-30Completed
Fractional CO2 Laser Assisted Topical Articaine Anesthesia vs. Topical EMLA Administration: a Randomized Controlled Study [NCT02548533]Phase 43 participants (Actual)Interventional2015-06-30Terminated(stopped due to Not enough patients eligible for recruitment.)
"Topic Effects of Eutectic Mixture Use in Local Anesthetics on Hemorrhoidectomy Postoperative (Prospective Study, Randomized, Triple Blind, Placebo-controlled)" [NCT00932542]Phase 2/Phase 3144 participants (Actual)Interventional2010-04-30Active, not recruiting
Topical Lidocaine-prilocaine Cream Versus Lidocaine Infiltration for Pain Relief During Repair of Postpartum Perineal Tears: A Randomized Controlled Trial [NCT02883179]Phase 4144 participants (Actual)Interventional2016-10-31Completed
Prospective Evaluation of Topical Analgesia Using a Lidocaine/Prilocaine Cream for Laceration Repair in the Emergency Department [NCT03071601]Phase 4132 participants (Actual)Interventional2017-12-01Completed
Local Anesthetics New Formulations: From Development to Clinical Tests [NCT01073371]Phase 132 participants (Actual)Interventional2008-07-31Completed
A Subject- and Evaluator-Blinded, Randomized, Multi-Center Study to Evaluate the Safety and Effectiveness of Injection With DGE Injectable Gel as Compared to an FDA-Approved Dermal Filler in Subjects Undergoing Cutaneous Correction of Nasolabial Folds [NCT00444626]Phase 3140 participants (Actual)Interventional2007-05-31Completed
The Comparison of the Discharge Conditions and Efficacy of Spinal Anesthesia With Heavy Prilocaine-Fentanyl and Heavy Bupivacaine-Fentanyl in Outpatient Minor Perianal Surgery [NCT01880775]Phase 450 participants (Actual)Interventional2012-04-30Completed
Cutaneous Microcirculation and Diabetic Foot [NCT01963559]80 participants (Actual)Interventional2012-04-30Completed
Evaluation of Local Anesthesia Before Arterial Puncture for Blood Gas Analysis Randomized, Control Placebo Study [NCT01964248]Phase 3136 participants (Actual)Interventional2012-12-31Completed
Investigation of the Effect of Central Sensitization on Steroid Injection Response in Patients With Shoulder Pain Secondary to Rotator Cuff Lesion [NCT05926895]36 participants (Anticipated)Interventional2023-06-02Recruiting
Impact of Local Anesthetic Concentration-Volume Modifications on Ultrasound Guided Infraclavicular Nerve Block Effectiveness [NCT02820688]Phase 481 participants (Actual)Interventional2016-06-30Completed
Prilocaine for Spinal Anesthesia in Ambulatory Setting: an Observational Retrospective Study [NCT04161586]3,291 participants (Actual)Observational2011-01-01Completed
Deep Sedation in Spontaneously Breathing Patients Combined With Local Anesthesia Versus General Anesthesia in Gynecological Patients at Same Day Surgical at Hospitalsenheden Horsens [NCT01412632]Phase 4153 participants (Actual)Interventional2011-11-30Completed
[NCT01425619]160 participants (Anticipated)Interventional2011-10-31Completed
EEG and Auditory Evoked Potentials During Local Anesthesia [NCT00408941]Phase 415 participants Interventional2006-12-31Not yet recruiting
Comparison Between the Effects of Lidocaine Prilocaine Cream and Lidocaine Injection on Reduction of Perineal Pain During Episiotomy and Perineum Repair in Vaginal Delivery: Randomized Control Trial [NCT05891132]60 participants (Anticipated)Interventional2023-09-01Not yet recruiting
Estimation of the ED95 of Intrathecal Hyperbaric Prilocaine 2% With Sufentanyl for Scheduled Cesarean Delivery : a Dose-finding Study Bases on the Continual Reassessment Method (CRM) [NCT03036384]Phase 240 participants (Actual)Interventional2016-03-31Completed
Local Anesthesia Effect on Tuberculin Skin Test Results in Infants and Children [NCT00309673]60 participants InterventionalNot yet recruiting
Comparative Safety and Efficacy of Cervical Lidocaine-Prilocaine Cream Versus Glyceryl Trinitrate Cream on Pain Perception During Levonorgestrel- Intrauterine Device Insertion Among Nulliparous Women: a Randomized Double-blind Controlled Trial [NCT04355598]Phase 4195 participants (Anticipated)Interventional2020-04-30Not yet recruiting
Comparative Safety and Efficacy of Vaginal Dinoprostone Versus Lidocaine-prilocaine Cream in Copper IUD Insertion in Nulliparous Women: a Randomized Controlled Trial [NCT04340778]Phase 3210 participants (Anticipated)Interventional2020-04-30Not yet recruiting
Comparison of the Short-term Clinical Effects of Anterior Extra-articular and Posterior Intra-articular Administration of Ultrasound-guided Steroid Injection in the Treatment of Adhesive Capsulitis. A Prospective, Randomized and Single-blind Study [NCT05668286]50 participants (Anticipated)Interventional2023-05-24Recruiting
Decision Support for Intraoperative Low Blood Pressure [NCT02726620]22,435 participants (Actual)Interventional2017-01-05Completed
Comparison of Hyperbaric Prilocaine With Chloroprocaine for Intrathecal Anaesthesia in Day Case Knee Arthroscopy [NCT03038958]Phase 480 participants (Actual)Interventional2016-04-30Completed
Prospective, Randomized, Double-blinded, Split-face Study Comparing Efficacy of Lidocaine 2.5%/Prilocaine 2.5% Cream Under Occlusion, and Lidocaine 23% /Tetracaine 7% Ointment for Anesthesia Prior to 1927nm Fractional Laser Treatment [NCT04523961]Phase 2/Phase 332 participants (Anticipated)Interventional2021-01-08Recruiting
The Efficacy of the Eutectic Mixture of Local Anesthetics (EMLA) Cream Versus the Synera Patch for Pain Reduction During Venipuncture in Children [NCT00530803]Phase 2100 participants (Actual)Interventional2007-06-30Completed
A Prospective Randomized Double Blind Comparison of 7,5 mg Hyperbaric Bupivacaine With 2,5mcg Sufentanyl or 50 mg Hyperbaric Prilocaine With 2,5 mcg Sufentanyl for Caesarean Sections [NCT03219086]182 participants (Actual)Interventional2017-08-01Completed
Ultrasound Guided Distal Sciatic Nerve Block - a Randomised Comparison With Nerve Stimulator Technique [NCT01643616]250 participants (Actual)Interventional2010-11-30Completed
An Exploratory Study in Healthy Volunteers to Investigate the Cross-talk Between Local Drug Concentrations in the Skin and Systemic Concentrations During Topical Bioequivalence Studies Using Dermal Sampling Techniques [NCT03813030]26 participants (Actual)Interventional2019-01-16Completed
Prospective Randomized Study Comparing Suprainguinal Fascia Iliaca Block vs. Pericapsular Nerve Group Block vs. Local Anesthetic Infiltration vs. Spinal Anesthetic Without Adjuncts for Pain Control Following Total Hip Arthroplasty [NCT05062356]Phase 1240 participants (Anticipated)Interventional2021-11-04Recruiting
Comparison Between the Effect of Prilocaine vs Bupivacaine on Hemodynamics in Spinal Anesthesia for Geriatric Patients Undergoing Endoscopic Urological Surgeries: A Randomized Controlled Trial [NCT06165679]Phase 3112 participants (Anticipated)Interventional2023-12-15Not yet recruiting
A Phase IIb, Multi-center, Randomized, Double-blind, Placebo-controlled Study, With Open-label Follow on, to Evaluate the Efficacy, Safety and Tolerability of PSD502 in Subjects With Premature Ejaculation (PE) [NCT00556478]Phase 2/Phase 3256 participants (Actual)Interventional2007-10-31Completed
Nexplanon Removal: Subcutaneous vs. Topical Lidocaine [NCT04467125]Phase 440 participants (Anticipated)Interventional2020-01-06Recruiting
The Effect of the Transcranial Direct Current Stimulation Combined Sensory Modulation Intervention on Upper Extremity Functional Rehabilitation in Patients With Chronic Stroke [NCT01847157]25 participants (Actual)Interventional2013-01-31Completed
Effect of Intrathecal Morphine on Urinary Bladder Function and Recovery in Patients Having a Cesarean Delivery - A Double-blind Randomized Clinical Trial [NCT05042817]56 participants (Actual)Interventional2021-10-01Completed
Selective Subarachnoid Anesthesia. Comparison of Hyperbaric Bupivacaine and Hyperbaric Prilocaine in Knee Arthroscopy and Inguinal Hernia Repair in Ambulatory Surgery [NCT01921231]Phase 4119 participants (Actual)Interventional2007-05-31Completed
Does Subarachnoid Administration of Hyperbaric Prilocaine Produce an Improved Recovery From Anaesthesia When Compared With Hyperbaric Bupivacaine When Used to Make Cervical Cerclage Easier in Pregnant Women at Risk of Pre-term Loss? [NCT04394533]Phase 4135 participants (Anticipated)Interventional2021-08-27Recruiting
Upshots of 5% Emla Cream Versus 20% Benzocaine on Pre-Injection Analgesia. [NCT05060913]Early Phase 170 participants (Actual)Interventional2021-11-17Completed
Ultrasound Guided Intermediate Cervical Plexus Block -Randomized Evaluation Concerning the Significance of Additional Perivascular Local Anesthetic Infiltration [NCT02336958]40 participants (Actual)Interventional2013-09-30Completed
Ultrasound-guided Block of the Brachial Plexus Using Prilocaine: Effects of Local-anesthetic Dose Reduction on Parameters of Block Quality and Adverse Effects in Outpatients [NCT01309360]Phase 4120 participants (Actual)Interventional2009-09-30Completed
Autofluorescent Flavoprotein Imaging of Intraepidermal Nerve Fibers: a Pilot Study [NCT02537951]10 participants (Actual)Interventional2015-09-30Completed
Efficacy of Topical Calcipotriol-assisted Ablative Fractional Laser Photodynamic Therapy for the Treatment of Actinic Keratosis: 12-month Follow-up Results of a Prospective, Randomised, Comparative Trial [NCT02976727]Phase 148 participants (Actual)Interventional2014-05-31Completed
Randomized, Single Center, Masked Study Comparing the Efficacy of Botulinum Toxin Type A Injection After Topical Anesthesia Versus Petrolatum Ointment [NCT03799484]Phase 414 participants (Actual)Interventional2019-01-04Completed
Simplifying the Shang Ring Technique for Circumcision of Men and Boys [NCT02390310]574 participants (Actual)Interventional2015-05-31Completed
Long-term Efficacy of Ablative Fractional Laser-assisted Photodynamic Therapy for Treatment of Lower Extremity Bowen's Disease: A Prospective, Randomized, Controlled Trial With 5-year Follow up [NCT03320447]Phase 160 participants (Actual)Interventional2011-10-30Completed
Efficacy of a Cold, Vibration, and Distraction Based Medical Device on the Prevention of Health Care Induced Pediatric Pain: a Comparative, Controlled, Randomized and Multicentric Study [NCT03220555]220 participants (Actual)Interventional2017-10-04Completed
Spinale Unilaterale o Blocco Nervoso Periferico Per le Artroscopie di Ginocchio in Day Surgery. Confronto Prospettico Randomizzato [NCT02384915]Phase 4100 participants (Actual)Interventional2015-01-31Completed
[NCT01673542]Phase 232 participants (Actual)Interventional2012-08-31Completed
Comparison of Infraclavicular and Supraclavicular Block Approaches in Ultrasound Guided Brachial Plexus Block [NCT04784104]Phase 470 participants (Anticipated)Interventional2021-03-05Not yet recruiting
Methemoglobin Levels in Generally Anesthetized Pediatric Dental Patients Receiving Prilocaine Versus Lidocaine [NCT01402869]91 participants (Actual)Interventional2011-08-31Completed
A Phase 4 Pediatric Study to Assess the Pharmacokinetics and Safety of Oraqix Gel in Healthy Children and Adolescent Volunteers Following Tooth Extraction [NCT01591616]Phase 416 participants (Actual)Interventional2010-04-30Completed
Comparison of Different Approaches for Supraclavicular Block and Their Effects on Diaphragm Muscle Function Evaluated With Diaphragm Thickening Fraction [NCT04756050]Phase 490 participants (Actual)Interventional2021-02-16Completed
A Randomized, Double Blind Trial of Pediatric Lumbar Puncture Under Sedation/Total Intravenous Anesthesia (TIVA) With and Without EMLA Cream [NCT01516684]Phase 233 participants (Actual)Interventional2012-05-14Completed
A Double-blind, Monocentric, Phase 3 Clinical Study for the Evaluation of Efficacy of a Topical Anesthetic Containing Lidocaine 25mg/g and Prilocaine 25mg/g in Adult Patients of Phototypes I to III in Treatment With CO2 Fractional Laser [NCT03366246]Phase 3120 participants (Actual)Interventional2014-06-07Completed
Topical Anesthetic Use In Pessary Management: A Randomized Double Blinded Placebo Controlled Trial [NCT02380742]Phase 254 participants (Actual)Interventional2015-07-31Completed
The Effect of Topical Anesthetic Using Lidocaine 2.5%/Prilocaine 2.5% Versus Lidocaine 7%/Tetracaine 7% Cream on Patients' Pain and Operative Experience During Treatment With QSwitched 532nm Laser [NCT02427724]48 participants (Anticipated)Interventional2015-04-30Active, not recruiting
Efficacy of Topical Lidocaine/Prilocaine in Pain Management in Pleurocentesis [NCT05984264]Phase 4118 participants (Anticipated)Interventional2023-01-01Recruiting
A Cross-over Study of Pharmacokinetic Interaction Comparing Nanoencapsulated Gel of Prilocaine (2.5%), Lidocaine (2.5%) and Association of Prilocaine + Lidocaine 2.5% (Nanorap®) Topically in Healthy Volunteers. [NCT03441841]Phase 148 participants (Actual)Interventional2016-02-28Completed
Comparison of The Efficacy of Lidocaine-Prilocaine Combination and Vapocoolant Spray to Reduce Pain of IV Cannulation in The Emergency Department: A Randomized Clinical Trial [NCT04473820]Phase 388 participants (Anticipated)Interventional2023-11-10Not yet recruiting
Comparative Safety and Efficacy of Vaginal Misoprostol Versus Lidocaine-prilocaine Cream in Reducing Pain During Levonorgestrel IUD Insertion in Women Delivered Only by Cesarean Deliveries [NCT04339348]Phase 3210 participants (Actual)Interventional2020-04-30Completed
Simultaneous Versus Sequential Fractional CO2 Laser and Subcision Combination for Post-acne Atrophic Scars: A Split-face Comparative Study. [NCT05688202]34 participants (Actual)Interventional2022-10-24Completed
ED50 of Intrathecal Hyperbaric 2% Prilocaine in Transperineal Magnetic Resonance Imaging-Transrectal Ultrasound Fusion Guided Biopsy [NCT05649020]Phase 490 participants (Anticipated)Interventional2022-11-24Recruiting
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00444626 (8) [back to overview]Number of Participants With Treatment-Emergent Adverse Events During the Initial Treatment Period
NCT00444626 (8) [back to overview]Participant's Pain Assessment During the Initial Treatment Measured on a Visual Analog Scale (VAS)
NCT00444626 (8) [back to overview]Number of Participants With Treatment-Emergent Adverse Events During the Repeat Treatment Period
NCT00444626 (8) [back to overview]Change From Baseline in the Blinded Evaluator's Assessment of Nasolabial Fold (NLF) Wrinkle Severity at Week 24
NCT00444626 (8) [back to overview]Change From Baseline in the Blinded Evaluator's Assessment of Nasolabial Folds (NLF) Wrinkle Severity at Week 36
NCT00444626 (8) [back to overview]Number of Participants With at Least a 1 Point Improvement From Baseline in the Blinded Evaluator's Assessment of Wrinkle Severity at Week 24
NCT00444626 (8) [back to overview]Participant Product Preference at Week 24
NCT00444626 (8) [back to overview]Participant Product Preference at Week 36
NCT00530803 (5) [back to overview]Blinded Observer's Subjective Ratings of the Participant's Pain Level at 5 Minutes Post Venipuncture Procedure, Using a 6-point NRS
NCT00530803 (5) [back to overview]Blinded Observer's Subjective Ratings of the Participant's Pain Level at Needle Insertion, Using a 6-point NRS
NCT00530803 (5) [back to overview]Parent Rating of Child's Pain Using a 6-point NRS
NCT00530803 (5) [back to overview]Blinded Observer's Subjective Ratings of Participants' Pain Level at Tourniquet Placement, Using a 6-point NRS
NCT00530803 (5) [back to overview]Participants Self-rating of Pain Using the Wong-Baker FACES Pain Rating Scale.
NCT00556478 (10) [back to overview]Change in Mean Intravaginal Ejaculatory Latency Time (IELT) From Baseline to Month 3
NCT00556478 (10) [back to overview]Mean Intravaginal Ejaculatory Latency Time (IELT): Change From Baseline to During 3 Month Double Blind-treatment
NCT00556478 (10) [back to overview]Change in the Index of Premature Ejaculation (IPE) Domains of Ejaculatory Control, Distress and Sexual Satisfaction From Baseline to Month 1
NCT00556478 (10) [back to overview]Change in the Index of Premature Ejaculation (IPE) Domains of Ejaculatory Control, Distress and Sexual Satisfaction From Baseline to Month 2
NCT00556478 (10) [back to overview]Index of Premature Ejaculation (IPE): Change From Baseline to End of Month 3
NCT00556478 (10) [back to overview]Partner Premature Ejaculation Profile (PEP) at Month 3
NCT00556478 (10) [back to overview]Percentage of Subjects With Mean Intravaginal Ejaculatory Latency Time (IELT) > 1 Minute and >2 Minutes During the 3 Months of Double-blind Treatment
NCT00556478 (10) [back to overview]Subject Premature Ejaculation Profile (PEP) at Month 3
NCT00556478 (10) [back to overview]Subject Premature Ejaculation Profile (PEP) at Month 2
NCT00556478 (10) [back to overview]Subject PEP at Month 1
NCT01309360 (6) [back to overview]Number of Participants With Complete Motor Blocks
NCT01309360 (6) [back to overview]Onset Time.
NCT01309360 (6) [back to overview]Number of Participants With Subjective Adverse Events as a Measure of Safety and Tolerability.
NCT01309360 (6) [back to overview]Number of Participants With Objective Adverse Events as a Measure of Safety and Tolerability
NCT01309360 (6) [back to overview]Number of Participants With Complete Sensory Block
NCT01309360 (6) [back to overview]Maximum Concentrations of Methemoglobin
NCT01402869 (3) [back to overview]Peak Methemoglobin Blood Levels
NCT01402869 (3) [back to overview]Time to Peak Methemoglobin Blood Levels
NCT01402869 (3) [back to overview]Delta Methemoglobin Blood Level
NCT01516684 (5) [back to overview]Complications Including Any Change in Vital Signs That Requires Intervention by the Sedation Team, as Well as Post-LP Headache From Sedation With or Without EMLA Cream
NCT01516684 (5) [back to overview]Complications Including Any Change in Vital Signs That Requires Intervention by the Sedation Team, Post-LP Back Pain From Sedation With or Without EMLA Cream
NCT01516684 (5) [back to overview]Total Dose of Propofol Administered to Each Patient
NCT01516684 (5) [back to overview]Level of Movement (no Movement, Minor Movement, Major Movement, Other) After EMLA Cream or Placebo Cream Administration
NCT01516684 (5) [back to overview]Traumatic Lumbar Punctures After EMLA Cream or Placebo Cream Administration
NCT01591616 (11) [back to overview]Pharmacokinetics
NCT01591616 (11) [back to overview]ECGs (PR Interval)
NCT01591616 (11) [back to overview]ECGs (QT Interval)
NCT01591616 (11) [back to overview]ECGs (QTcB Interval)
NCT01591616 (11) [back to overview]ECGs (Ventricular Heart Rate)
NCT01591616 (11) [back to overview]Pharmacokinetics
NCT01591616 (11) [back to overview]ECGs (QRS Duration)
NCT01591616 (11) [back to overview]Safety
NCT01591616 (11) [back to overview]Vital Signs (Diastolic Pressure)
NCT01591616 (11) [back to overview]Vital Signs (Pulse)
NCT01591616 (11) [back to overview]Vital Signs (Systolic Pressure)
NCT01643616 (3) [back to overview]Time Until Readiness for Surgery (Minutes)
NCT01643616 (3) [back to overview]Success Rate Without Supplementation
NCT01643616 (3) [back to overview]Success Rate With Supplementation
NCT02336958 (2) [back to overview]Number of Patients With Required Supplementation of Local Anesthetic by Surgeon
NCT02336958 (2) [back to overview]Amount (ml) of Local Anesthetic Supplemented by Surgeon
NCT02380742 (4) [back to overview]VAS Score at the Time of Pessary Insertion Adjusting for Baseline Pain
NCT02380742 (4) [back to overview]VAS Score at the Time of Pessary Removal Adjusting for Baseline Pain
NCT02380742 (4) [back to overview]VAS Score at the Time of Pessary Removal Adjusting for Baseline Pain and Patient Age
NCT02380742 (4) [back to overview]VAS Score at the Time of Pessary Removal Adjusting for Pessary Type and Investigator Training
NCT02537951 (1) [back to overview]AFI-intensity After Nociceptive Stimulation
NCT02726620 (43) [back to overview]Incidence of a MAP < 50 mmHg
NCT02726620 (43) [back to overview]Incidence of a MAP < 50 mmHg for > 10 Minutes
NCT02726620 (43) [back to overview]Incidence of a MAP < 50 mmHg 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]Incidence of a MAP < 55 mmHg for > 20 Minutes
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]Depth and Duration of Intraoperative Hypotension - Threshold MAP 75 mmHg
NCT02726620 (43) [back to overview]Timing of Cardiovascular Drugs for MAP < 50 mmHg
NCT02726620 (43) [back to overview]Timing of Cardiovascular Drugs for MAP < 55 mmHg
NCT02726620 (43) [back to overview]Timing of Cardiovascular Drugs for MAP < 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]Usage Frequency of Cardiovascular Drugs: Phenylephrine
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]Inhaled Anesthetic Drug Use During Intraoperative Hypotension: MAP < 60 mmHg
NCT02726620 (43) [back to overview]Inhaled Anesthetic Drug Use During Intraoperative Hypotension: MAP < 65 mmHg
NCT02726620 (43) [back to overview]Time to Discharge Readiness at the Postanesthesia Care Unit (PACU)
NCT02726620 (43) [back to overview]30-day Mortality
NCT02726620 (43) [back to overview]Average Use of Cardiovascular Drugs: Ephedrine
NCT02726620 (43) [back to overview]Average Use of Cardiovascular Drugs: Epinephrine
NCT02726620 (43) [back to overview]Average Use of Cardiovascular Drugs: Glycopyrrolate
NCT02726620 (43) [back to overview]Average Use of Cardiovascular Drugs: Norepinephrine
NCT02726620 (43) [back to overview]Average Use of Cardiovascular Drugs: Phenylephrine
NCT02726620 (43) [back to overview]Depth and Duration of Intraoperative Hypotension - Threshold MAP 50 mmHg
NCT02726620 (43) [back to overview]Depth and Duration of Intraoperative Hypotension - Threshold MAP 55 mmHg
NCT02726620 (43) [back to overview]Depth and Duration of Intraoperative Hypotension - Threshold MAP 60 mmHg
NCT02726620 (43) [back to overview]Depth and Duration of Intraoperative Hypotension - Threshold MAP 65 mmHg
NCT02726620 (43) [back to overview]Depth and Duration of Intraoperative Hypotension - Threshold MAP 70 mmHg
NCT02726620 (43) [back to overview]Estimated Intraoperative Blood Loss
NCT02726620 (43) [back to overview]In-hospital Mortality
NCT02973048 (22) [back to overview]Total Blood Loss
NCT02973048 (22) [back to overview]Pain as Assessed by Visual Analogue Scale
NCT02973048 (22) [back to overview]Number of Participants With Adverse Events (Nausea, Vomiting, Pruritis, Headache)
NCT02973048 (22) [back to overview]Number of Patients With Hypotension and Use of Vasopressors
NCT02973048 (22) [back to overview]Newborn Apgar Score
NCT02973048 (22) [back to overview]Time to First Walk
NCT02973048 (22) [back to overview]Time to Successful Anesthesia (Successful Sensory Block)
NCT02973048 (22) [back to overview]Time to Resolution of Sensory Block
NCT02973048 (22) [back to overview]Time to Regression of Motor Block
NCT02973048 (22) [back to overview]Time to Motor Block Onset
NCT02973048 (22) [back to overview]Newborn Umbilical pH
NCT02973048 (22) [back to overview]Time of Surgery
NCT02973048 (22) [back to overview]Time From Spinal Injection to Baby Delivery
NCT02973048 (22) [back to overview]Obstetrician Satisfaction
NCT02973048 (22) [back to overview]Number of Participants With Urinary Retention
NCT02973048 (22) [back to overview]Number of Participants With Transient Neurologic Symptoms (TNS)
NCT02973048 (22) [back to overview]Number of Participants Per Maximal Level of Sensory Block Attained After Spinal Anesthesia
NCT02973048 (22) [back to overview]Time From Baby Delivery to End of Surgery
NCT02973048 (22) [back to overview]Newborn Methemoglobinemia (MetHb)
NCT02973048 (22) [back to overview]Midwife Satisfaction
NCT02973048 (22) [back to overview]Maternal Satisfaction Assessed by Visual Analogic Scale (VASS)
NCT02973048 (22) [back to overview]Maternal Rehabilitation Assessed by Visual Analogic Scale (VASR)
NCT03036384 (14) [back to overview]Bromage Motor Block Level at End of Surgery
NCT03036384 (14) [back to overview]Newborn Apgar Score
NCT03036384 (14) [back to overview]Sensitive Block Duration
NCT03036384 (14) [back to overview]Sensitive Block at End of Surgery
NCT03036384 (14) [back to overview]Success of Anesthesia
NCT03036384 (14) [back to overview]Number of Satisfied Participants
NCT03036384 (14) [back to overview]Number of Participants With Urinary Retention
NCT03036384 (14) [back to overview]Number of Participants With Transient Neurologic Symptoms (TNS)
NCT03036384 (14) [back to overview]Number of Participants With Pruritus
NCT03036384 (14) [back to overview]Number of Participants With Nausea or Vomiting
NCT03036384 (14) [back to overview]Number of Participants With Dizziness
NCT03036384 (14) [back to overview]Number of Participants Needing Vasopressors
NCT03036384 (14) [back to overview]Newborn Methemoglobinemia (MetHb)
NCT03036384 (14) [back to overview]Motor Block Duration
NCT03799484 (9) [back to overview]Duration of Botulinum Toxin Type A Effect
NCT03799484 (9) [back to overview]Eyebrow Excursion
NCT03799484 (9) [back to overview]Eyebrow Excursion
NCT03799484 (9) [back to overview]Eyebrow Excursion
NCT03799484 (9) [back to overview]Number of Participants Who Perceive a Difference in Efficacy Between the 2 Sides of Their Face
NCT03799484 (9) [back to overview]Number of Participants Who Perceive a Difference in Efficacy Between the 2 Sides of Their Face
NCT03799484 (9) [back to overview]Number of Participants Who Perceive a Difference in Efficacy Between the 2 Sides of Their Face
NCT03799484 (9) [back to overview]Perception of Pain Immediately After Injection as Assessed by a Visual Analogue Scale
NCT03799484 (9) [back to overview]Eyebrow Excursion

Number of Participants With Treatment-Emergent Adverse Events During the Initial Treatment Period

"Counts of participants with treatment-emergent adverse events (AEs) from the time of injection up to Week 36. AEs are presented regardless of relationship to study device and/or procedure.~If a participant had more than one occurrence of the same AE, he/she was counted only once. The most severe occurrence of an AE, as well as the most extreme relationship of the AE to the device, was indicated in cases of multiple occurrences of the same AE. For AEs by relationship, procedure-related and device-related AEs are not mutually exclusive and therefore are not additive." (NCT00444626)
Timeframe: Weeks 1-36

,,
InterventionParticipants (Number)
Patients with at least one Adverse Event (AE)AEs by Severity - MildAEs by Severity - ModerateAEs by Severity - SevereAEs by Relationship - Procedure or DeviceAEs by Relationship - Procedure RelatedAEs by Relationship - Device RelatedAEs by Duration - less than or equal to 7 daysAEs by Duration - more than 7 daysAEs by Treatment - No TreatmentAEs by Treatment - MedicationAEs by Treatment - Non-drug TherapyAEs by Treatment - HospitalizationPatients with Baseline AEsPatients with Serious AEsPatients with Study Discontinuation due to AEsNumber of Deaths
Dermal Gel Extra (DGE)99473715986991702954133200000
Non-NLF2813105532523618310110
Restylane895824787617867225782400000

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Participant's Pain Assessment During the Initial Treatment Measured on a Visual Analog Scale (VAS)

The pain experienced by each participant at the time of injection (time 0) and at 15 and 30 minutes after injection during the initial treatment visit was evaluated. Pain was measured using a VAS of 0 mm (no pain) to 100 mm (extreme pain). (NCT00444626)
Timeframe: Day 1

,
InterventionUnits on a scale (Mean)
0 time after injection15 minutes after injection30 minutes after injection
Dermal Gel Extra (DGE)23.26.13.3
Restylane48.916.37.9

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Number of Participants With Treatment-Emergent Adverse Events During the Repeat Treatment Period

"Count of participants with treatment-emergent adverse events (AEs) from the time of injection for the repeat treatment period up to week 47. AEs are presented regardless of relationship to study device and/or procedure.~If a participant had more than one occurrence of the same AE, he/she was counted only once. The most severe occurrence of an AE, as well as most extreme relationship of the AE to the device, was indicated in cases of multiple occurrences of the same AE. For AEs by relationship, procedure-related and device-related AEs are not mutually exclusive and therefore are not additive." (NCT00444626)
Timeframe: weeks 36 up to 47 weeks

,,
InterventionParticipants (Number)
Patients with at least one Adverse Event (AE)AEs by Severity - MildAEs by Severity - ModerateAEs by Severity - SevereAEs by Relationship - Procedure or Device (DGE)AEs by Relationship - Procedure RelatedAEs by Relationship - Device (DGE) RelatedAEs by Duration - less than or equal to 7 daysAEs by Duration - more than 7 daysAEs by Treatment - No TreatmentAEs by Treatment - MedicationAEs by Treatment - Non-drug TherapyAEs by Treatment - HospitalizationPatients with a Serious AEsPatients with Study Discontinuation due to AEsNumber of Deaths
Dermal Gel Extra (DGE)5532194545051441141770000
Non-NLF9522222723600100
Restylane - Dermal Gel Extra (DGE)523415350464744840570000

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Change From Baseline in the Blinded Evaluator's Assessment of Nasolabial Fold (NLF) Wrinkle Severity at Week 24

"This was a comparison of the mean change between Baseline and the Week 24 score (baseline minus week 24 scores) in the blinded evaluators' assessments of NLF wrinkle severity. A positive value for the mean change indicates an improvement.~Genzyme 6-Point Grading Scale (GGS) for NLF was used for the assessment. A GGS score of zero indicates no wrinkles and a score of 5 indicates very deep wrinkles with redundant folds." (NCT00444626)
Timeframe: Week 24

InterventionUnits on a scale (Mean)
Dermal Gel Extra (DGE)1.8
Restylane1.8

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Change From Baseline in the Blinded Evaluator's Assessment of Nasolabial Folds (NLF) Wrinkle Severity at Week 36

"Mean change between Baseline and the Week 36 score (Baseline minus week 36 scores) in the blinded evaluators' assessments of NLF wrinkle severity. A positive value for the mean change indicates an improvement.~Genzyme 6-Point Grading Scale (GGS) for NLF was used for the assessment. A GGS score of zero indicates no wrinkles and a score of 5 indicates very deep wrinkles with redundant folds." (NCT00444626)
Timeframe: Week 36

InterventionUnits on a scale (Mean)
Dermal Gel Extra (DGE)1.3
Restylane1.3

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Number of Participants With at Least a 1 Point Improvement From Baseline in the Blinded Evaluator's Assessment of Wrinkle Severity at Week 24

Count of participants with at least a 1-point improvement from Baseline in the Genzyme 6-Point Grading Scale (GGS) at Week 24. A GGS score of zero indicates no wrinkles and a score of 5 indicates very deep wrinkles with redundant folds. (NCT00444626)
Timeframe: Week 24

InterventionParticipants (Number)
Dermal Gel Extra (DGE)114
Restylane113

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Participant Product Preference at Week 24

Participants indicated their product preference at Week 24 after Date of Optimal Correction (DOC). (NCT00444626)
Timeframe: Week 24

InterventionParticipants (Number)
Dermal Gel Extra (DGE)56
Restylane68

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Participant Product Preference at Week 36

Participants indicated their product preference at Week 36 after Date of Optimal Correction (DOC). (NCT00444626)
Timeframe: Week 36

InterventionParticipants (Number)
Dermal Gel Extra (DGE)62
Restylane55

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Blinded Observer's Subjective Ratings of the Participant's Pain Level at 5 Minutes Post Venipuncture Procedure, Using a 6-point NRS

The NRS (Numerical Rating Scale) is a 6-point rating scale where 0= no pain and 5 = worst pain. Blinded observers reported their own subjective evaluation of the level of pain participants were experiencing 5 minutes after the venipuncture was completed. Total number of participants subjectively evaluated as experiencing each pain level is reported. (NCT00530803)
Timeframe: 5 minutes post venipuncture

,
InterventionParticipants (Count of Participants)
Participants evaluated at NRS = 0 (No pain)Participants evaluated at NRS = 1Participants evaluated at NRS = 2Participants evaluated at NRS = 3Participants evaluated at NRS = 4Participants evaluated at NRS = 5
EMLA Cream4531100
Synera Patch4541000

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Blinded Observer's Subjective Ratings of the Participant's Pain Level at Needle Insertion, Using a 6-point NRS

The NRS (Numerical Rating Scale) is a 6-point rating scale where 0= no pain and 5 = worst pain. Blinded observers reported their own subjective evaluation of the level of pain experienced by the participants at needle insertion. Total number of participants subjectively evaluated as experiencing each pain level is reported. (NCT00530803)
Timeframe: during needle insertion

,
InterventionParticipants (Count of Participants)
Participants evaluated at NRS = 0 (No pain)Participants evaluated at NRS = 1Participants evaluated at NRS = 2Participants evaluated at NRS = 3Participants evaluated at NRS = 4Participants evaluated at NRS = 5
EMLA Cream32142200
Synera Patch25129220

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Parent Rating of Child's Pain Using a 6-point NRS

The Numerical Rating Scale (NRS) is a 6-point rating scale where 0= no pain and 5 = worst pain. Parents reported their own subjective evaluation of participants pain level. Each participant had only one parental assessment. Total number of parental assessment for each pain level on the 6-point NRS is reported as total number of participants experiencing that pain level. (NCT00530803)
Timeframe: immediately after venipuncture is completed

,
InterventionParticipants (Count of Participants)
number of participants with NRS=0 (no pain)number of participants with NRS=1number of participants with NRS=2number of participants with NRS=3number of participants with NRS=4number of participants with NRS=5
EMLA Cream4261100
Synera Patch4151201

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Blinded Observer's Subjective Ratings of Participants' Pain Level at Tourniquet Placement, Using a 6-point NRS

The NRS (Numerical Rating Scale) is a 6-point rating scale where 0= no pain and 5 = worst pain. Blinded observers reported their own subjective evaluation of the level of pain experienced by the participants at tourniquet placement. Total number of participants subjectively evaluated as experiencing each pain level is reported. (NCT00530803)
Timeframe: before venipuncture

,
InterventionParticipants (Count of Participants)
Participants evaluated at NRS = 0 (No pain)Participants evaluated at NRS = 1Participants evaluated at NRS = 2Participants evaluated at NRS = 3Participants evaluated at NRS = 4Participants evaluated at NRS = 5
EMLA Cream4162100
Synera Patch3765110

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Participants Self-rating of Pain Using the Wong-Baker FACES Pain Rating Scale.

"Participants were asked to report their level of pain using a 6-point Wong-Baker FACES Pain Rating Scale ranging from 0, no pain, to 5, the most pain you can have. The Wong-Baker FACES Pain Rating Scale is a validated tool for measuring pain in patients as young as 3 years old. A FACES pain score less than or equal to 2 is considered no pain to mild pain, and is clinically acceptable. Studies have shown average FACES pain scores for children receiving vascular access with placebo to be 2.2 to 3.5." (NCT00530803)
Timeframe: immediately after completion of venipuncture

,
InterventionParticipants (Count of Participants)
Participants with FACES Score = 0 (No pain)Participants with FACES Score = 1Participants with FACES Score = 2Participants with FACES Score = 3Participants with FACES Score = 4Participants with FACES Score = 5
EMLA Cream4262000
Synera Patch3883100

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Change in Mean Intravaginal Ejaculatory Latency Time (IELT) From Baseline to Month 3

Summary of mean IELT at Baseline and at month 3 during double-blind treatment (NCT00556478)
Timeframe: 3 months

InterventionSeconds (Geometric Mean)
Double-Blind Active / Open-Label Active140.964
Double-Blind Placebo / Open-Label Active49.615

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Mean Intravaginal Ejaculatory Latency Time (IELT): Change From Baseline to During 3 Month Double Blind-treatment

"To evaluate efficacy of treatment with PSD502 compared with placebo in subjects with PE as measured by:~• change in mean IELT from baseline to during the 3 month double-blind treatment~Results provide are ratio (over the 3 months/baseline)." (NCT00556478)
Timeframe: Baseline to 3 Months

Interventionratio (Geometric Mean)
Double-Blind Active / Open-Label Active4.607
Double-Blind Placebo / Open-Label Active1.505

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Change in the Index of Premature Ejaculation (IPE) Domains of Ejaculatory Control, Distress and Sexual Satisfaction From Baseline to Month 1

"Change in the IPE domains of ejaculatory control, distress and sexual satisfaction from Baseline to month 1.~Ejaculatory control scores range from 4 to 20 with a higher score indicating greater ejaculatory control Sexual satisfaction scores range from 4 to 20 with a higher score indicating greater sexual satisfaction Distress scores range from 2 to 10 with a higher score indicating less distress" (NCT00556478)
Timeframe: 1 month

,
InterventionScore (Mean)
Ejaculatory controlDistressSexual satisfaction
Double-Blind Active / Open-Label Active5.72.55.1
Double-Blind Placebo / Open-Label Active1.30.61.8

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Change in the Index of Premature Ejaculation (IPE) Domains of Ejaculatory Control, Distress and Sexual Satisfaction From Baseline to Month 2

"Change in the IPE domains of ejaculatory control, distress and sexual satisfaction from Baseline to month 2~Ejaculatory control scores range from 4 to 20 with a higher score indicating greater ejaculatory control Sexual satisfaction scores range from 4 to 20 with a higher score indicating greater sexual satisfaction Distress scores range from 2 to 10 with a higher score indicating less distress" (NCT00556478)
Timeframe: 2 months

,
InterventionScore (Mean)
ControlSatisfactionDistress
Double-Blind Active / Open-Label Active6.55.82.9
Double-Blind Placebo / Open-Label Active1.41.30.7

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Index of Premature Ejaculation (IPE): Change From Baseline to End of Month 3

"To Evaluate Efficacy of Treatment With PSD502 Compared With Placebo in Subjects With PE as measured by:~• changes in all 3 IPE domains from baseline to month 3~Ejaculatory control scores range from 4 to 20 with a higher score indicating greater ejaculatory control Sexual satisfaction scores range from 4 to 20 with a higher score indicating greater sexual satisfaction Distress scores range from 2 to 10 with a higher score indicating less distress" (NCT00556478)
Timeframe: Baseline to 3 Months

,
InterventionScore (Mean)
Ejaculatory controlSexual satisfactionDistress
Double-Blind Active / Open-Label Active7.26.63.5
Double-Blind Placebo / Open-Label Active2.22.10.9

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Partner Premature Ejaculation Profile (PEP) at Month 3

Scores for perceived control over ejaculation, personal distress related to ejaculation, satisfaction with sexual intercourse and interpersonal difficulty related to ejaculation based on the partner PEP at month 3. Proportion of partners with at least a 1 point category improvement in partner PEP domain scores from baseline to month 3. (NCT00556478)
Timeframe: 3 months

,
Interventionpercentage of partners (Number)
ControlDistressSexual satisfactionInterpersonal difficulty
Double-Blind Active / Open-Label Active68.964.962.866.9
Double-Blind Placebo / Open-Label Active40.850.032.950.0

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Percentage of Subjects With Mean Intravaginal Ejaculatory Latency Time (IELT) > 1 Minute and >2 Minutes During the 3 Months of Double-blind Treatment

Percentage of subjects with mean IELT > 1 minute and >2 minutes during the 3 months of double-blind treatment as measured by the proportion of subjects (NCT00556478)
Timeframe: 3 months

,
Interventionpercentage of subjects (Number)
IELT > 1 minuteIELT > 2 minutes
Double-Blind Active / Open-Label Active80.257.5
Double-Blind Placebo / Open-Label Active37.814.6

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Subject Premature Ejaculation Profile (PEP) at Month 3

Scores for perceived control over ejaculation, personal distress related to ejaculation, satisfaction with sexual intercourse and interpersonal difficulty related to ejaculation based on the subject PEP at month 3. Proportion of subjects with at least a 1 point category improvement in subject PEP domain scores from baseline to month 3. (NCT00556478)
Timeframe: 3 months

,
Interventionpercentage of participants (Number)
ControlDistressSexual satisfactionInterpersonal difficulty
Double-Blind Active / Open-Label Active72.476.973.777.6
Double-Blind Placebo / Open-Label Active24.136.736.759.5

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Subject Premature Ejaculation Profile (PEP) at Month 2

Scores for perceived control over ejaculation, personal distress related to ejaculation, satisfaction with sexual intercourse and interpersonal difficulty related to ejaculation based on the subject PEP at month 2. Proportion of subjects with at least a 1 point category improvement in subject PEP domain scores from baseline to month 2. (NCT00556478)
Timeframe: 2 months

,
Interventionpercentage of participants (Number)
ControlDistressSexual satisfactionInterpersonal difficulty
Double-Blind Active / Open-Label Active67.570.169.475.8
Double-Blind Placebo / Open-Label Active24.733.827.342.9

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Subject PEP at Month 1

Scores for perceived control over ejaculation, personal distress related to ejaculation, satisfaction with sexual intercourse and interpersonal difficulty related to ejaculation based on the subject PEP at month 1. Percentage of subjects with at least a 1 point category improvement in subject PEP domain scores at month 1. (NCT00556478)
Timeframe: 1 month

,
Interventionpercentage of participants (Number)
ControlDistressSexual satisfactionInterpersonal difficulty
Double-Blind Active / Open-Label Active59.663.462.772.0
Double-Blind Placebo / Open-Label Active23.527.233.351.9

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Number of Participants With Complete Motor Blocks

To examine the extent of the motor block the manual muscle function test after Vladimir Janda was used. As a complete motor block was defined, when no motion (grade zero after Janda) of muscles innervated by the four blocked nerves (musculocutaneous, median, radial and ulnar nerve) was observed within 60 minutes after administration of the local anesthetic. (NCT01309360)
Timeframe: Within 60 minutes after administration of the local anesthetic

Interventionparticipants (Number)
Group A : 40ml Prilocaine 1%38
Group B : 30ml Prilocaine 1%36
Group C : 20ml Prilocaine 1%32

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Onset Time.

Time from beginning of administration of the local anesthetic until complete sensoric block. (NCT01309360)
Timeframe: within 60 minutes after administration of the local anesthetic

Interventionminutes (Mean)
Group A : 40ml Prilocaine 1%18
Group B : 30ml Prilocaine 1%20
Group C : 20ml Prilocaine 1%26

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Number of Participants With Subjective Adverse Events as a Measure of Safety and Tolerability.

In groups A, B and C was determined the rate of subjective clinical signs of increased Met-Hb-Levels : headaches or dizziness, when correlated with the peak-Met-Hb-Level. (NCT01309360)
Timeframe: Outpatients were followed for the duration of hospital stay, an average of six hours.

Interventionparticipants (Number)
Group A : 40ml Prilocaine 1%4
Group B : 30ml Prilocaine 1%0
Group C : 20ml Prilocaine 1%0

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Number of Participants With Objective Adverse Events as a Measure of Safety and Tolerability

In groups A, B and C was determined the rate of objective clinical signs of increased Met-Hb-levels : drops in oxygen saturation <93% using pulseoximetry or lip cyanosis. (NCT01309360)
Timeframe: Outpatients were followed for the duration of hospital stay, an average of six hours.

Interventionparticipants (Number)
Group A : 40ml Prilocaine 1%13
Group B : 30ml Prilocaine 1%5
Group C : 20ml Prilocaine 1%1

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Number of Participants With Complete Sensory Block

The number of outpatients with complete sensory block of all 4 nerves (n.musculocutaneous, n.radialis, n.ulnaris,n.medianus) was registrated in each group. (NCT01309360)
Timeframe: 60 minutes after administration of the local anesthetic

Interventionparticipants (Number)
Group A : 40ml Prilocaine 1%38
Group B : 30ml Prilocaine 1%39
Group C : 20ml Prilocaine 1%39

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Maximum Concentrations of Methemoglobin

Concentration of Methemoglobin (Met-Hb) was measured using spectrophotometry prior to the anesthesia (baseline value) and then hourly after performing the block until a clear decrease became apparent. The maximum amount was reached in every case two or three hours after administration of the local anesthetic. (NCT01309360)
Timeframe: 0,1,2,3,4 hours post-dose

Interventionpercentage of methemoglobin (Mean)
Group A : 40ml Prilocaine 1%4.7
Group B : 30ml Prilocaine 1%3.7
Group C : 20ml Prilocaine 1%2.4

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Peak Methemoglobin Blood Levels

The maximum percentage of methemoglobin in blood (NCT01402869)
Timeframe: Measured at 10 second intervals during dental treatment for an average of 2 hours

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

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Time to Peak Methemoglobin Blood Levels

The length of time between the administration of local anesthetic (Prilocaine and Lidocaine Groups) or start of restorative dental procedures (No local anesthetic Group) and the time at which the maximum methemoglobin blood level is observed. (NCT01402869)
Timeframe: Measured at 10 second intervals during dental treatment for an average of 2 hours

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

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Delta Methemoglobin Blood Level

Change in percentage of methemoglobin in blood from baseline level to peak level (NCT01402869)
Timeframe: From administration of local anesthetic or start of restorative procedures to time at which maximum methemoglobin blood level was documented during dental treatment for an average of 2 hours

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

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Complications Including Any Change in Vital Signs That Requires Intervention by the Sedation Team, as Well as Post-LP Headache From Sedation With or Without EMLA Cream

Each patient's parent (and/or the patient) will be contacted by telephone within one week of the lumbar puncture (or in person if the next clinic visit is within one week) to ask if the patient had any headache after the lumbar puncture, and if they had any other complications. (NCT01516684)
Timeframe: Within one week of the LP

InterventionProbability of experiencing headache (Mean)
Arm A (EMLA)0.194
Arm B (Placebo)0.289

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Complications Including Any Change in Vital Signs That Requires Intervention by the Sedation Team, Post-LP Back Pain From Sedation With or Without EMLA Cream

Each patient's parent (and/or the patient) will be contacted by telephone within one week of the lumbar puncture (or in person if the next clinic visit is within one week) to ask if the patient had any back pain after the lumbar puncture, and if they had any other complications. (NCT01516684)
Timeframe: Within one week of the LP

InterventionProbability of experiencing back pain (Mean)
Arm A (EMLA)0.211
Arm B (Placebo)0.250

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Total Dose of Propofol Administered to Each Patient

Analyzed using descriptive statistics and mixed model regression methods. Raw mean total dose administered and raw percentage of times additional propofol was administered will be presented by sedation group treating each event (sedation with lumbar puncture) as the unit. T-test and chi-square tests will be performed as appropriate. (NCT01516684)
Timeframe: 20 minutes after sedation

Interventionmg/kg (Least Squares Mean)
Arm A (EMLA)2.94
Arm B (Placebo)3.22

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Level of Movement (no Movement, Minor Movement, Major Movement, Other) After EMLA Cream or Placebo Cream Administration

(NCT01516684)
Timeframe: At the time of LP insertion

,
InterventionTrials (Count of Units)
No movementMinor movementMajor movementOther
Arm A (EMLA)507810
Arm B (Placebo)2912279

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Traumatic Lumbar Punctures After EMLA Cream or Placebo Cream Administration

Traumatic lumbar puncture is defined as lumbar puncture in which cerebrospinal fluid contains at least 10 red blood cells (RBCs) per microliter and bloody lumbar as one in which the cerebrospinal fluid contained at least 500 red blood cells (RBCs) per microliter. (NCT01516684)
Timeframe: 20 minutes after lumbar puncture

,
InterventionTrials (Count of Units)
AtraumaticTraumaticBloody
Arm A (EMLA)6361
Arm B (Placebo)5754

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Pharmacokinetics

The study focused on the pharmacokinetics of prilocaine and lidocaine, o-toluidine (metabolite of prilocaine) and 2, 6-xylidine (metabolite of lidocaine). We evaluated blood samples of15 subjects at the following time points: pre-dose, at 5,10,15,30, 60, 90, 120 and 240 min post dose. We calculated Cmax (maximum observed plasma concentration) and Tmax (time to maximum plasma concentration). (NCT01591616)
Timeframe: 5, 10, 15, 30, 60, 90, 120, and 240 minutes

Interventionng/mL (Geometric Mean)
Lidocaine Cmax89.9
Prilocaine Cmax41.8
2,6-xylidine Cmax3.72
O-toluidine Cmax5.13

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ECGs (PR Interval)

Ventricular heart rate, PR interval, QRS duration, QT interval, and QTcB intervals were calculated. (NCT01591616)
Timeframe: Pre-dose, 1 hour, 2 hour, 4 hour post-dose.

Interventionmilliseconds (Mean)
PR Interval, Pre-dose148
PR Interval, 1 Hour Post-dose147
PR Interval, 2 Hour Post-dose147
PR Interval, 4 Hour Post-dose139

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ECGs (QT Interval)

Ventricular heart rate, PR interval, QRS duration, QT interval, and QTcB intervals were calculated. (NCT01591616)
Timeframe: Pre-dose, 1 hour, 2 hour, 4 hour post-dose.

Interventionmilliseconds (Mean)
QT Interval, Pre-dose376
QT Interval, 1 Hour Post-dose384
QT Interval, 2 Hour Post-dose383
QT Interval, 4 Hour Post-dose379

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ECGs (QTcB Interval)

Ventricular heart rate, PR interval, QRS duration, QT interval, and QTcB intervals were calculated. (NCT01591616)
Timeframe: Pre-dose, 1 hour, 2 hour, 4 hour post-dose.

Interventionmilliseconds (Mean)
QTcB Interval, Pre-dose412
QTcB Interval, 1 Hour Post-dose413
QTcB Interval, 2 Hour Post-dose415
QTcB Interval, 4 Hour Post-dose419

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ECGs (Ventricular Heart Rate)

Ventricular heart rate, PR interval, QRS duration, QT interval, and QTcB intervals were calculated. (NCT01591616)
Timeframe: Pre-dose, 1 hour, 2 hour, 4 hour post-dose.

InterventionBeats per minute (Mean)
Ventricular Heart Rate, Pre-dose73
Ventricular Heart Rate, 1 Hour Post-dose70
Ventricular Heart Rate, 2 Hour Post-dose71
Ventricular Heart Rate, 4 Hour Post-dose74

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Pharmacokinetics

The study focused on the pharmacokinetics of prilocaine and lidocaine, o-toluidine (metabolite of prilocaine) and 2, 6-xylidine (metabolite of lidocaine). We evaluated blood samples of15 subjects at the following time points: pre-dose, at 5,10,15,30, 60, 90, 120 and 240 min post dose. We calculated Cmax (maximum observed plasma concentration) and Tmax (time to maximum plasma concentration). (NCT01591616)
Timeframe: 5, 10, 15, 30, 60, 90, 120, and 240 minutes

Interventionhours (Geometric Mean)
Lidocaine Tmax0.500
Prilocaine Tmax0.500
2,6-xylidine Tmax1.50
O-toluidine Tmax1.50

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ECGs (QRS Duration)

Ventricular heart rate, PR interval, QRS duration, QT interval, and QTcB intervals were calculated. (NCT01591616)
Timeframe: Pre-dose, 1 hour, 2 hour, 4 hour post-dose.

Interventionmilliseconds (Mean)
QRS Duration, Pre-dose77
QRS Duration, 1 Hour Post-dose76
QRS Duration, 2 Hour Post-dose75
QRS Duration, 4 Hour Post-dose74

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Safety

"The % MetHb levels and vital signs (pulse, systolic and diastolic pressure) were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.~ECG taken at pre-dose and 1, 2 and 4h post dose, measurement of heart rate and PR, QRS, QT and QTcB intervals.~Visual analogue scale conducted at pre-dose (immediately before Oraqix administration), immed. post extraction, at 0.25, 0.5, 1 and 2h post dose and prior to discharge just after 4h post dose.~For each subject, phone call was made at +24h as follow up pursuant to the protocol." (NCT01591616)
Timeframe: blood draws pre-dose, 2 and 4 hours postdose

InterventionPercentage MetHb (Mean)
% MetHemoglobin (MetHb) Time Point -20 Minutes1.3
% MetHemoglobin (MetHb) Time Point -10 Minutes1.3
% MetHemoglobin (MetHb) Time Point 0 Minutes1.2
% MetHemoglobin (MetHb) Time Point 10 Minutes1.2
% MetHemoglobin (MetHb) Time Point 20 Minutes1.3
% MetHemoglobin (MetHb) Time Point 30 Minutes1.5
% MetHemoglobin (MetHb) Time Point 40 Minutes1.5
% MetHemoglobin (MetHb) Time Point 50 Minutes1.6
% MetHemoglobin (MetHb) Time Point 60 Minutes1.7
% MetHemoglobin (MetHb) Time Point 70 Minutes1.7
% MetHemoglobin (MetHb) Time Point 80 Minutes1.5
% MetHemoglobin (MetHb) Time Point 90 Minutes1.5
% MetHemoglobin (MetHb) Time Point 100 Minutes1.5
% MetHemoglobin (MetHb) Time Point 110 Minutes1.6
% MetHemoglobin (MetHb) Time Point 120 Minutes1.5
% MetHemoglobin (MetHb) Time Point 130 Minutes1.5
% MetHemoglobin (MetHb) Time Point 140 Minutes1.4
% MetHemoglobin (MetHb) Time Point 150 Minutes1.4
% MetHemoglobin (MetHb) Time Point 160 Minutes1.3
% MetHemoglobin (MetHb) Time Point 170 Minutes1.2
% MetHemoglobin (MetHb) Time Point 180 Minutes1.4
% MetHemoglobin (MetHb) Time Point 190 Minutes1.4
% MetHemoglobin (MetHb) Time Point 200 Minutes1.5
% MetHemoglobin (MetHb) Time Point 210 Minutes1.4
% MetHemoglobin (MetHb) Time Point 220 Minutes1.4
% MetHemoglobin (MetHb) Time Point 230 Minutes1.5
% MetHemoglobin (MetHb) Time Point 240 Minutes1.4

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Vital Signs (Diastolic Pressure)

(NCT01591616)
Timeframe: Pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose

InterventionmmHg (Mean)
Vital Signs (Diastolic), - 20 Minutes Pre-dose63
Vital Signs (Diastolic), - 10 Minutes Pre-dose60
Vital Signs (Diastolic), 0 Minutes Pre-dose63
Vital Signs (Diastolic), 10 Minutes Post-dose69
Vital Signs (Diastolic), 20 Minutes Post-dose63
Vital Signs (Diastolic), 30 Minutes Post-dose64
Vital Signs (Diastolic), 40 Minutes Post-dose62
Vital Signs (Diastolic), 50 Minutes Post-dose62
Vital Signs Diastolic(), 60 Minutes Post-dose62
Vital Signs (Diastolic), 70 Minutes Post-dose62
Vital Signs (Diastolic) 80 Minutes Post-dose62
Vital Signs (Diastolic), 90 Minutes Post-dose64
Vital Signs (Diastolic), 100 Minutes Post-dose63
Vital Signs (Diastolic), 110 Minutes Post-dose63
Vital Signs (Diastolic), 120 Minutes Post-dose60
Vital Signs Diastolic(), 130 Minutes Post-dose62
Vital Signs (Diastolic), 140 Minutes Post-dose62
Vital Signs (Diastolic), 150 Minutes Post-dose63
Vital Signs (Diastolic), 160 Minutes Post-dose63
Vital Signs (Diastolic), 170 Minutes Post-dose60
Vital Signs (Diastolic), 180 Minutes Post-dose60
Vital Signs (Diastolic), 190 Minutes Post-dose61
Vital Signs (Diastolic), 200 Minutes Post-dose60
Vital Signs (Diastolic), 210 Minutes Post-dose59
Vital Signs (Diastolic), 220 Minutes Post-dose57
Vital Signs (Diastolic), 230 Minutes Post-dose57
Vital Signs (Diastolic), 240 Minutes Post-dose60

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Vital Signs (Pulse)

Vital signs (pulse, systolic and diastolic pressure) were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose. (NCT01591616)
Timeframe: Pre-dose and every 10 minute to 240 minutes post-dose.

InterventionBeats per minute (Mean)
Vital Signs (Pulse Rate), - 20 Minutes Pre-dose74
Vital Signs (Pulse Rate), - 10 Minutes Pre-dose72
Vital Signs (Pulse Rate), 0 Minutes Pre-dose72
Vital Signs (Pulse Rate), 10 Minutes Post-dose79
Vital Signs (Pulse Rate), 20 Minutes Post-dose71
Vital Signs (Pulse Rate), 30 Minutes Post-dose72
Vital Signs (Pulse Rate), 40 Minutes Post-dose71
Vital Signs (Pulse Rate), 50 Minutes Post-dose70
Vital Signs (Pulse Rate), 60 Minutes Post-dose71
Vital Signs (Pulse Rate), 70 Minutes Post-dose74
Vital Signs (Pulse Rate), 80 Minutes Post-dose72
Vital Signs (Pulse Rate), 90 Minutes Post-dose71
Vital Signs (Pulse Rate), 100 Minutes Post-dose70
Vital Signs (Pulse Rate), 110 Minutes Post-dose72
Vital Signs (Pulse Rate), 120 Minutes Post-dose70
Vital Signs (Pulse Rate), 130 Minutes Post-dose71
Vital Signs (Pulse Rate), 140 Minutes Post-dose72
Vital Signs (Pulse Rate), 150 Minutes Post-dose72
Vital Signs (Pulse Rate), 160 Minutes Post-dose74
Vital Signs (Pulse Rate), 170 Minutes Post-dose74
Vital Signs (Pulse Rate), 180 Minutes Post-dose73
Vital Signs (Pulse Rate), 190 Minutes Post-dose72
Vital Signs (Pulse Rate), 200 Minutes Post-dose75
Vital Signs (Pulse Rate), 210 Minutes Post-dose72
Vital Signs (Pulse Rate), 220 Minutes Post-dose70
Vital Signs (Pulse Rate), 230 Minutes Post-dose72
Vital Signs (Pulse Rate), 240 Minutes Post-dose77

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Vital Signs (Systolic Pressure)

(NCT01591616)
Timeframe: Pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.

InterventionmmHg (Mean)
Vital Signs (Systolic), - 20 Minutes Pre-dose110
Vital Signs (Systolic), - 10 Minutes Pre-dose104
Vital Signs (Systolic), 0 Minutes Pre-dose106
Vital Signs (Systolic), 10 Minutes Post-dose115
Vital Signs (Systolic), 20 Minutes Post-dose109
Vital Signs (Systolic), 30 Minutes Post-dose108
Vital Signs (Systolic), 40 Minutes Post-dose106
Vital Signs (Systolic), 50 Minutes Post-dose106
Vital Signs (Systolic), 60 Minutes Post-dose105
Vital Signs (Systolic), 70 Minutes Post-dose106
Vital Signs (Systolic) 80 Minutes Post-dose104
Vital Signs (Systolic), 90 Minutes Post-dose106
Vital Signs (Systolic), 100 Minutes Post-dose106
Vital Signs (Systolic), 110 Minutes Post-dose106
Vital Signs (Systolic), 120 Minutes Post-dose106
Vital Signs (Systolic), 130 Minutes Post-dose105
Vital Signs (Systolic), 140 Minutes Post-dose108
Vital Signs (Systolic), 150 Minutes Post-dose107
Vital Signs (Systolic), 160 Minutes Post-dose105
Vital Signs (Systolic), 170 Minutes Post-dose106
Vital Signs (Systolic), 180 Minutes Post-dose104
Vital Signs (Systolic), 190 Minutes Post-dose103
Vital Signs (Systolic), 200 Minutes Post-dose103
Vital Signs (Systolic), 210 Minutes Post-dose102
Vital Signs (Systolic), 220 Minutes Post-dose104
Vital Signs (Systolic), 230 Minutes Post-dose102
Vital Signs (Systolic), 240 Minutes Post-dose102

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Time Until Readiness for Surgery (Minutes)

(NCT01643616)
Timeframe: within 60 minutes after injection of the local anesthetic

Interventionminutes (Mean)
Group US15.1
Group NS28

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Success Rate Without Supplementation

"After injection of local anesthetic a waiting period of 30-60 minutes was defined before completing a failed block.~success without supplementation = no additional analgetics or rescue blocks required (success rate without supplementation, outcome measure 1)~success with supplementation = analgetics or selective rescue blocks distal of the sciatic division required (success rate without supplementation and additionally all supplemented blocks, outcome measure 3)~failed block = change of anesthetic procedure (general, spinal) or rescue blocks proximal of the sciatic division" (NCT01643616)
Timeframe: within 30-60 minutes after injection of the local anesthetic

Interventionparticipants (Number)
Group US112
Group NS73

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Success Rate With Supplementation

"After injection of local anesthetic a waiting period of 30-60 minutes was defined before completing a failed block.~success without supplementation = no additional analgetics or rescue blocks required (success rate without supplementation, outcome measure 1)~success with supplementation = analgetics or selective rescue blocks distal of the sciatic division required (success rate without supplementation and additionally all supplemented blocks, outcome measure 3)~failed block = change of anesthetic procedure (general, spinal) or rescue blocks proximal of the sciatic divisionSucces rate with supplementation" (NCT01643616)
Timeframe: later than 30-60 minutes after injection of the local anesthetic

Interventionparticipants (Number)
Group US116
Group NS85

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Number of Patients With Required Supplementation of Local Anesthetic by Surgeon

(NCT02336958)
Timeframe: during the intraoperative period

Interventionparticipants (Number)
Ropivacaine13
Saline13

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Amount (ml) of Local Anesthetic Supplemented by Surgeon

(NCT02336958)
Timeframe: during the intraoperative period

Interventionml (Mean)
Ropivacaine4.9
Saline3.7

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VAS Score at the Time of Pessary Insertion Adjusting for Baseline Pain

Practitioner's perception of patient's pain score at time of pessary insertion adjusting for baseline pain. Scale is from 0 to 10 centimeters (0=no pain and 10=worst pain) (NCT02380742)
Timeframe: Insertion of Pessary

InterventionCentimeters (Least Squares Mean)
Lidocaine-prilocaine0.61
Placebo1.68

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VAS Score at the Time of Pessary Removal Adjusting for Baseline Pain

Self-reported pain intensity at time of pessary removal controlling for baseline pain. Scale is from 0 to 10 (0=no pain and 10=worst pain) (NCT02380742)
Timeframe: Removal of Pessary

InterventionCentimeters (Least Squares Mean)
Lidocaine-prilocaine1.76
Placebo3.81

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VAS Score at the Time of Pessary Removal Adjusting for Baseline Pain and Patient Age

Self-reported pain intensity at time of pessary removal after controlling for patient age and baseline pain score. Scale is from 0 to 10 centimeters (0=no pain and 10=worst pain) (NCT02380742)
Timeframe: Removal of Pessary

InterventionCentimeters (Least Squares Mean)
Lidocaine-prilocaine1.88
Placebo3.69

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VAS Score at the Time of Pessary Removal Adjusting for Pessary Type and Investigator Training

Self-reported pain intensity at time of pessary removal after controlling for pessary type and investigator training level. Scale is from 0 to 10 centimeters (0=no pain and 10=worst pain) (NCT02380742)
Timeframe: Removal of Pessary

InterventionCentimeters (Least Squares Mean)
Lidocaine-prilocaine1.81
Placebo3.76

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AFI-intensity After Nociceptive Stimulation

AFI-intensity (delta F/F) at the 3rd fingertip, directly after application of grading nociceptive stimuli (NCT02537951)
Timeframe: Day 1, T=0h (AFI measurements), Day 1, T=6h (AFI measurements after lidocaine/prilocaine), Day 7 (AFI measurements after capsaicin)

Interventionunitless (Mean)
AFI Intensity in Healthy Volunteers0.60
Negative Control 1: Lidocaine/Prilocaine0.25
Negative Control 2: 8% Capsaicin0.50

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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 < 50 mmHg for > 10 Minutes

Incidence of a mean arterial pressure (MAP) < 50 mmHg for a cumulative duration of all hypotensive episodes of more than 10 minutes during the anesthetic phase of the procedure. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

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

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Incidence of a MAP < 50 mmHg 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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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 < 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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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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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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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 < 60 mmHg

Cardiovascular drugs as defined under interventions. Time of first administration of cardiovascular drug relative to the time at which the mean arterial pressure (MAP) drops below 60 mmHg. Per patient the average time to first administration of all hypotensive episodes was calculated. That average time is used as the outcome variable. A negative value indicates that administration occurred before the drop in MAP. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

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

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Timing of Cardiovascular Drugs for MAP < 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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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 < 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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Inhaled Anesthetic Drug Use During Intraoperative Hypotension: MAP < 60 mmHg

Average concentrations of inhalational anesthesia during MAP < 60 mmHg episodes (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

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

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Inhaled Anesthetic Drug Use During Intraoperative Hypotension: MAP < 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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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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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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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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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: 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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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: 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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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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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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Depth and Duration of Intraoperative Hypotension - Threshold MAP 60 mmHg

Depth and duration of intraoperative hypotension will be modeled by calculating areas under the threshold for mean arterial pressures (MAPs). Thresholds will vary from 75 mmHg to 50 mmHg in 5 mmHg decrements. Together these variables represent the depth and duration of intraoperative hypotension. To optimize goodness of fit of these variables, the decremental steps may be increased to 10 mmHg and more restrictive lowest and highest thresholds may be chosen for the statistical analysis. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

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

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Depth and Duration of Intraoperative Hypotension - Threshold MAP 65 mmHg

Depth and duration of intraoperative hypotension will be modeled by calculating areas under the threshold for mean arterial pressures (MAPs). Thresholds will vary from 75 mmHg to 50 mmHg in 5 mmHg decrements. Together these variables represent the depth and duration of intraoperative hypotension. To optimize goodness of fit of these variables, the decremental steps may be increased to 10 mmHg and more restrictive lowest and highest thresholds may be chosen for the statistical analysis. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

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

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Depth and Duration of Intraoperative Hypotension - Threshold MAP 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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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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Total Blood Loss

Total blood loss (milliliters) during surgery (NCT02973048)
Timeframe: average 1 hour

Interventionmilliliters (Median)
Hyperbaric Bupivacaine415
Hyperbaric Prilocaine485

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Pain as Assessed by Visual Analogue Scale

Pain levels will be determined at incision, baby delivery, peritoneal and skin closure, every 5 minutes during surgery, and thereafter every 4 hours for 24 hours. Visual analog pain score (scale = 0 no pain; 10 = worst pain imaginable). Patient will receive additional analgesic treatment above VAS>3. (NCT02973048)
Timeframe: up to 24 hours after surgery

InterventionParticipants (Count of Participants)
VAS at 1 Hour72548744VAS at 1 Hour72548745VAS at 2 Hours72548744VAS at 2 Hours72548745VAS at 3 Hours72548744VAS at 3 Hours72548745VAS at 4 Hours72548744VAS at 4 Hours72548745
VAS 1-2 (No additional analgesic treatment)VAS >3 (additional analgesic treatment)VAS=0 (no pain)
Hyperbaric Bupivacaine13
Hyperbaric Prilocaine7
Hyperbaric Bupivacaine6
Hyperbaric Prilocaine9
Hyperbaric Bupivacaine0
Hyperbaric Prilocaine1
Hyperbaric Bupivacaine11
Hyperbaric Prilocaine3
Hyperbaric Prilocaine13
Hyperbaric Bupivacaine9
Hyperbaric Prilocaine6
Hyperbaric Bupivacaine3
Hyperbaric Prilocaine2
Hyperbaric Bupivacaine10
Hyperbaric Prilocaine12
Hyperbaric Bupivacaine7
Hyperbaric Prilocaine5
Hyperbaric Bupivacaine2
Hyperbaric Prilocaine0

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Number of Participants With Adverse Events (Nausea, Vomiting, Pruritis, Headache)

Evaluation from 15 minutes after spinal injection to the end of surgery, then every 4 hours for 24 hours, then once a day for 3 days (score 0=no symptom; 1=symptom with no necessary treatment; 2=symptom present and treated) (NCT02973048)
Timeframe: up to 72 hours after surgery

InterventionParticipants (Count of Participants)
Peroperative72548744Peroperative72548745Day 072548744Day 072548745Day 172548744Day 172548745Day 272548744Day 272548745Day 372548744Day 372548745
score 0 (no symptom)score 1 (symptom with no necessary treatment)score 2 (symptom present and treated)
Hyperbaric Prilocaine13
Hyperbaric Prilocaine1
Hyperbaric Prilocaine3
Hyperbaric Bupivacaine14
Hyperbaric Prilocaine12
Hyperbaric Bupivacaine4
Hyperbaric Prilocaine5
Hyperbaric Prilocaine0
Hyperbaric Bupivacaine16
Hyperbaric Prilocaine17
Hyperbaric Bupivacaine3
Hyperbaric Bupivacaine18
Hyperbaric Bupivacaine1
Hyperbaric Bupivacaine0

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Number of Patients With Hypotension and Use of Vasopressors

Arterial blood pressure will be measured at every 1 minute during the first 15 minutes, then at every 2.5 minutes until the end of surgery, and at every 20 minutes in the Post Anesthesia Care Unit (PACU). A low blood pressure (hypotension) is defined as a systolic blood pressure lower than 20% or more than the basal blood pressure (Systolic blood pressure before spinal anesthesia) (NCT02973048)
Timeframe: up to 2 hours after surgery

,
InterventionParticipants (Count of Participants)
HypotensionVasopressors use
Hyperbaric Bupivacaine1716
Hyperbaric Prilocaine910

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Newborn Apgar Score

"Newborn Apgar score assessed at 1, 5, 10 minutes after baby extraction. The Apgar score is determined by evaluating the newborn baby on five simple criteria on a scale from 0 to 2, then summing up the five values thus obtained. The overall resulting score ranges from 0 to 10 ( 0-3 : severely depressed, 4-6 : Moderately depressed and 7-10 : Excellent condition).~The five criteria are summarized using words chosen to form an abbreviation (Appearance, Pulse, Grimace, Activity, Respiration)." (NCT02973048)
Timeframe: up to 10 minutes after baby extraction

,
Interventionscore on a scale (Median)
Apgar at 1 minuteApgar at 3 minutesApgar at 5 minutes
Hyperbaric Bupivacaine91010
Hyperbaric Prilocaine91010

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Time to First Walk

Time for the patients to be able to walk in their room then in the hallway without any assistance for the first time. (NCT02973048)
Timeframe: up to 24h after surgery

InterventionMinutes (Median)
Hyperbaric Bupivacaine318
Hyperbaric Prilocaine198

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Time to Successful Anesthesia (Successful Sensory Block)

Time between spinal injection and reached bilateral T4 sensory level. (NCT02973048)
Timeframe: From spinal injection of the local anesthetic to bilateral T4 level (average 20 minutes)

Interventionminutes (Mean)
Hyperbaric Bupivacaine9.63
Hyperbaric Prilocaine11.18

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Time to Resolution of Sensory Block

Evaluation at every 2 minutes after spinal anesthesia during 15 minutes, then every 5 minutes until the end of surgery, and thereafter, every 30 minutes until total regression of sensory block (T12-S1). (NCT02973048)
Timeframe: until complete release of sensory block (T12-S1) (average 4 hours)

Interventionminutes (Mean)
Hyperbaric Bupivacaine212.95
Hyperbaric Prilocaine169.59

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Time to Regression of Motor Block

Time to regression of motor block is the time between maximal blockade (score 1, as evaluated by the Modified Bromage scale), and no blockade (score 6). Degree of motor blockade is assessed before and 10, 15, 20 minutes after spinal anesthesia, then every 15 minutes until the end of surgery, and thereafter, every 30 minutes until complete regression of motor block (NCT02973048)
Timeframe: until complete regression of motor block (up to 4 hours)

Interventionminutes (Median)
Hyperbaric Bupivacaine180
Hyperbaric Prilocaine130

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Time to Motor Block Onset

Time of installation of the motor block (time between spinal injection and maximum motor block of 1, as evaluated by the Modified Bromage scale). Degree of motor blockade is assessed before and 10, 15, 20 minutes after spinal anesthesia (NCT02973048)
Timeframe: From spinal injection of the local anesthetic to bilateral T4 level and during surgery (average 1 hour)

Interventionminutes (Median)
Hyperbaric Bupivacaine16
Hyperbaric Prilocaine10

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Newborn Umbilical pH

Newborn umbilical pH will be assessed at delivery by cordal blood sample, as a routine control, and expressed as standard value (NCT02973048)
Timeframe: average 1 hour

InterventionpH (Median)
Hyperbaric Bupivacaine7.33
Hyperbaric Prilocaine7.32

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Time of Surgery

Time between incision and end of surgery (NCT02973048)
Timeframe: average 1 hour

Interventionminutes (Median)
Hyperbaric Bupivacaine45
Hyperbaric Prilocaine50

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Time From Spinal Injection to Baby Delivery

Time between spinal injection and baby delivery (NCT02973048)
Timeframe: average 1 hour

Interventionminutes (Median)
Hyperbaric Bupivacaine24
Hyperbaric Prilocaine25

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Obstetrician Satisfaction

Satisfaction ranged between 1 (totally unsatisfied) to 4 (totally satisfied) assessed at the end of surgery (NCT02973048)
Timeframe: average 1 hour

Interventionscore on a scale (Median)
Hyperbaric Bupivacaine4
Hyperbaric Prilocaine4

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Number of Participants With Urinary Retention

All parturients will be questioned and examined for urinary retention (yes or no) (NCT02973048)
Timeframe: up to 4 hours after surgery

InterventionParticipants (Count of Participants)
Hyperbaric Bupivacaine2
Hyperbaric Prilocaine2

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Number of Participants With Transient Neurologic Symptoms (TNS)

Evaluation of apparition of TNS at postoperative Day 1, postoperative Day 2, postoperative Day 3 and postoperative Day 15. TNS are defined as pain and/or dysesthesia occurred after complete release of sensory block at the gluteal level, at the thighs and at the legs. (NCT02973048)
Timeframe: up to 15 Days after surgery

InterventionParticipants (Count of Participants)
Hyperbaric Bupivacaine0
Hyperbaric Prilocaine0

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Number of Participants Per Maximal Level of Sensory Block Attained After Spinal Anesthesia

"Level of Sensory block is assessed as loss of sensation to cold, and represents the dermatomal level under which anesthesia is effective. It is measured every 2 minutes after spinal anesthesia during 15 minutes, then every 5 minutes until the end of surgery, thereafter, once 30 minutes until total regression of sensory block (T12-S1). A dermatome is the area of skin that is supplied by a single spinal nerve - Dermatome levels : C5-C8 for Cervical levels and T1-T4 for Thoracic levels.~To perform cesarean section loss of cold sensation at a dermatome of at least T4 has to be obtained.~The results are expressed as the number of patients reaching each dermatomal level from T4 and above (see below) as maximal sensory level, this is a usual outcome used to evaluate the quality of anesthesia." (NCT02973048)
Timeframe: until complete release of sensory block (T12-S1) (average 4 hours)

,
InterventionParticipants (Count of Participants)
Sensory level dermatome C5Sensory level dermatome C6Sensory level dermatome C7Sensory level dermatome C8Sensory level dermatome T1Sensory level dermatome T2Sensory level dermatome T3Sensory level dermatome T4
Hyperbaric Bupivacaine03020473
Hyperbaric Prilocaine11010266

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Time From Baby Delivery to End of Surgery

Time between baby delivery, and the end of surgery (NCT02973048)
Timeframe: average 1 hour

Interventionminutes (Mean)
Hyperbaric Bupivacaine36.68
Hyperbaric Prilocaine38.24

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Newborn Methemoglobinemia (MetHb)

"Newborn Methemoglobinemia (MetHb) will be assessed at delivery by cordal blood sample, as a routine control in obstetrics, and expressed as a percentage of total hemoglobinemia.~Methemoglobinemia (MetHb) is a blood disorder in which an abnormal amount of methemoglobin (hemoglobin in the form metalloprotein) is produced. This specific type of of Hemoglobin carries oxygen through your blood but doesn't release it to the cells." (NCT02973048)
Timeframe: average 1 hour

Interventionpercentage of MetHb (Median)
Hyperbaric Bupivacaine1.8
Hyperbaric Prilocaine1.7

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Midwife Satisfaction

Satisfaction ranged between 1 (totally unsatisfied) to 4 (totally satisfied) assessed at postoperative Day 3 (NCT02973048)
Timeframe: 72 hours after surgery

Interventionscore on a scale (Median)
Hyperbaric Bupivacaine3
Hyperbaric Prilocaine4

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Maternal Satisfaction Assessed by Visual Analogic Scale (VASS)

All patients will be asked to rate their satisfaction about anesthetic technique during surgery and in the arrival in the Post Anesthesia Care Unit (PACU). Satisfaction evaluated by Visual analog scale (0 cm= very unsatisfied and 10cm = very satisfied) (NCT02973048)
Timeframe: up to 24 hours after surgery

Interventionscore on a scale (Median)
Hyperbaric Bupivacaine9
Hyperbaric Prilocaine9

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Maternal Rehabilitation Assessed by Visual Analogic Scale (VASR)

Maternal rehabilitation is evaluated at postoperative Day1, postoperative Day 2 and postoperative Day 3. Evaluation by Visual analog scale (0 cm= very poor and 10cm = excellent) (NCT02973048)
Timeframe: up to 72 hours after surgery

Interventionscore on a scale (Median)
Hyperbaric Bupivacaine9
Hyperbaric Prilocaine9

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Bromage Motor Block Level at End of Surgery

Bromage scale (1 = no motor block; 2 = hip blocked; 3 = hip and knee blocked; and 4 = hip, knee, and ankle blocked) was used to evaluate the motor block every 15 min after spinal anaesthesia (T0) and until the end of surgery. (NCT03036384)
Timeframe: Until complete release of motor block (average 4 hours)

Interventionscore on a scale (Mean)
45mg HB Prilocaine3.56
50mg HB Prilocaine4.00

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Newborn Apgar Score

"Newborn Apgar score assessed at 1, 5, 10 minutes after baby extraction. The Apgar score is determined by evaluating the newborn baby on five simple criteria on a scale from 0 to 2, then summing up the five values thus obtained. The overall resulting score ranges from 0 to 10 ( 0-3 : severely depressed, 4-6 : Moderately depressed and 7-10 : Excellent condition).~The five criteria are summarized using words chosen to form an abbreviation (Appearance, Pulse, Grimace, Activity, Respiration)." (NCT03036384)
Timeframe: up to 10 minutes after baby extraction

,
Interventionscore on a scale (Mean)
Apgar at 1 minuteApgar at 5 minutesApgar at 10 minutes
45mg HB Prilocaine8.479.639.84
50mg HB Prilocaine9.009.7510

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Sensitive Block Duration

Level of Sensory block assessed as loss of sensation to cold, every 2 minutes after spinal anesthesia during 15 minutes, then every 5 minutes until the end of surgery, thereafter, once 30 minutes until total regression of sensory block (T12-S1). (NCT03036384)
Timeframe: Until complete release of sensory block (T12-S1) (average 4 hours)

Interventionhours (Mean)
45mg HB Prilocaine2.31
50mg HB Prilocaine3.25

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Sensitive Block at End of Surgery

Level of Sensory block assessed as loss of sensation to cold, every 2 minutes after spinal anesthesia during 15 minutes, then every 5 minutes until the end of surgery, thereafter, once 30 minutes until total regression of sensory block (T12-S1). For this study, dermatome levels are depicted on a scale ranging from 1 to 18. (1 to 12 = T1-T12 thoracic levels; 13 to 17 = L1-L5 lumbar levels; 18 = S1 sacral level) (NCT03036384)
Timeframe: Until complete release of sensory block (T12-S1) (average 4 hours)

InterventionDermatome level (Median)
45mg HB Prilocaine3.88
50mg HB Prilocaine3.00

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Success of Anesthesia

The nerve blockade will be considered as success when a bilateral T4 level will reach in 15 minutes after intrathecal injection without additional epidural injection needed within 45 minutes peri-operative ; no pain at the skin incision, no pain during 45 minutes after the skin incision (NCT03036384)
Timeframe: during surgery (average 1 hour)

,,,,,,,,,
InterventionParticipants (Count of Participants)
SuccessFailure
Cohort 140
Cohort 1031
Cohort 240
Cohort 340
Cohort 413
Cohort 540
Cohort 640
Cohort 740
Cohort 840
Cohort 931

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Number of Satisfied Participants

Maternal satisfaction (yes or no) will be assessed 1 hour after surgery in the PACU (Post Anesthesia Care Unit) (NCT03036384)
Timeframe: up to 1 hour after surgery

InterventionParticipants (Count of Participants)
45mg HB Prilocaine16
50mg HB Prilocaine4

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Number of Participants With Urinary Retention

All parturients will be questioned for urinary retention (yes or no) (NCT03036384)
Timeframe: Up to 24 hours after surgery

InterventionParticipants (Count of Participants)
45mg HB Prilocaine0
50mg HB Prilocaine0

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Number of Participants With Transient Neurologic Symptoms (TNS)

TNS are defined as pain and/or dysesthesia occurred after complete release of sensory block at the gluteal level, at the thighs and at the legs. At Day 0, Day 1, Day 3 and Day 5 (NCT03036384)
Timeframe: up to 5 Days

InterventionParticipants (Count of Participants)
45mg HB Prilocaine0
50mg HB Prilocaine0

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Number of Participants With Pruritus

from 15 minutes after spinal anesthesia and every 4 hours for 24 hours (score 0=no symptoms; 1=symptoms with no treatment necessary; 2=symptoms present and treated) (NCT03036384)
Timeframe: Up to 24 hours after surgery

InterventionParticipants (Count of Participants)
45mg HB Prilocaine0
50mg HB Prilocaine0

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Number of Participants With Nausea or Vomiting

from 15 minutes after spinal anesthesia and every 4 hours for 24 hours (score 0=no symptoms; 1=symptoms with no treatment necessary; 2=symptoms present and treated) (NCT03036384)
Timeframe: up to 24 hours after surgery

InterventionParticipants (Count of Participants)
45mg HB Prilocaine3
50mg HB Prilocaine0

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Number of Participants With Dizziness

All parturients will be questioned for dizziness (yes or no) (NCT03036384)
Timeframe: Up to 24 hours after surgery

InterventionParticipants (Count of Participants)
45mg HB Prilocaine5
50mg HB Prilocaine2

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Number of Participants Needing Vasopressors

"Arterial blood pressure will be measured at every 2.5 minute during surgery, then at every 20 minutes in the PACU (Post Anesthesia Care Unit). Vasopressors were given for patients with low blood pressure.~A low blood pressure is defined as a blood pressure lower than 20% or more than the basal blood pressure (Systolic blood pressure before spinal anesthesia)." (NCT03036384)
Timeframe: during surgery (average 1 hour)

InterventionParticipants (Count of Participants)
45mg HB Prilocaine15
50mg HB Prilocaine2

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Newborn Methemoglobinemia (MetHb)

Newborn Methemoglobinemia (MetHb) will be assessed at delivery by cordal blood sample, as a routine control, and expressed as a percentage of total hemoglobinemia. (NCT03036384)
Timeframe: average 1 hour

Interventionpercentage of MetHb (Mean)
45mg HB Prilocaine1.59
50mg HB Prilocaine1.60

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Motor Block Duration

Bromage scale (1 = no motor block; 2 = hip blocked; 3 = hip and knee blocked; and 4 = hip, knee, and ankle blocked) was used to evaluate the motor block every 15 minutes after spinal anaesthesia (T0) and until the end of surgery. Duration was defined from the time of the spinal injection until Bromage scale = 1. (NCT03036384)
Timeframe: Until complete release of motor block (Bromage scale = 1; average 4 hours)

Interventionhours (Mean)
45mg HB Prilocaine2.75
50mg HB Prilocaine3.50

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Duration of Botulinum Toxin Type A Effect

Loss of Botulinum Toxin Type A effect is defined as return of baseline frontalis muscle function (function prior to injection) as indicated by eyebrow excursion measurement within 2 millimeters of baseline value. (NCT03799484)
Timeframe: week 16

Interventionweeks (Mean)
Topical Anesthesia14.2857
Petrolatum15.2857

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Eyebrow Excursion

(NCT03799484)
Timeframe: week 16

Interventionmillimeters (Mean)
Topical Anesthesia8.21
Petrolatum8.07

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Eyebrow Excursion

Participants will be asked to raise the brows, and the excursion of the brow from resting position to maximum elevation will be measured in millimeters. (NCT03799484)
Timeframe: Baseline

Interventionmillimeters (Mean)
Topical Anesthesia10.57
Petrolatum10.57

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Eyebrow Excursion

Participants will be asked to raise the brows, and the excursion of the brow from resting position to maximum elevation will be measured in millimeters. (NCT03799484)
Timeframe: Week 2

Interventionmillimeters (Mean)
Topical Anesthesia3.46
Petrolatum3.43

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Number of Participants Who Perceive a Difference in Efficacy Between the 2 Sides of Their Face

Participants will be asked if there is a noticeable difference between the 2 sides of their face. (NCT03799484)
Timeframe: Week 16

InterventionParticipants (Count of Participants)
All Participants0

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Number of Participants Who Perceive a Difference in Efficacy Between the 2 Sides of Their Face

Participants will be asked if there is a noticeable difference between the 2 sides of their face. (NCT03799484)
Timeframe: Week 2

InterventionParticipants (Count of Participants)
All Participants3

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Number of Participants Who Perceive a Difference in Efficacy Between the 2 Sides of Their Face

Participants will be asked if there is a noticeable difference between the 2 sides of their face. (NCT03799484)
Timeframe: Week 6

InterventionParticipants (Count of Participants)
All Participants2

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Perception of Pain Immediately After Injection as Assessed by a Visual Analogue Scale

A visual analogue scale will be used to assess pain. The scale ranges from 0 (no pain) to 10 (the worse pain possible), with lower scores indicating a better outcome. (NCT03799484)
Timeframe: Immediately after botox injection

Interventionunits on a scale (Mean)
Topical Anesthesia2.43
Petrolatum3.96

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Eyebrow Excursion

Participants will be asked to raise the brows, and the excursion of the brow from resting position to maximum elevation will be measured in millimeters. (NCT03799484)
Timeframe: Week 6

Interventionmillimeters (Mean)
Topical Anesthesia5.96
Petrolatum5.68

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