NCT02973048|CompletedPhase 3Results
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Sponsor study identifier
interventional
40
1 country
2
Study Start
March 12, 2018
Actual (reported)Primary Completion
November 8, 2018
Actual (reported)Study Completion
November 8, 2018
Actual (reported)Over the past 15 years, cesarean delivery is most commonly performed under spinal anesthesia using hyperbaric bupivacaine which provides an adequate sensory and motor block. Despite effective surgical anesthesia, bupivacaine is associated with long duration motor block and dose-dependent maternal hypotension potentially harmful for the fetus. Prilocaine with its new 2% hyperbaric formulation (HP), developed recently, showed rapid onset of action and faster regression of motor block compared to other local anesthetics without noteworthy side-effects when used intrathecally. The aim of this randomized, multicenter, powered clinical trial is to investigate whether HP may be an efficient alternative to hyperbaric bupivacaine for scheduled caesarean delivery under spinal anesthesia, with more rapid rehabilitation and less adverse effects. Our hypothesis is that hyperbaric prilocaine offers shorter motor block and more rapid rehabilitation than bupivacaine.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 8, 2018
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 25, 2016
Actual (reported)November 25, 2016
Actual (reported)March 12, 2018
Actual (reported)November 8, 2018
Actual (reported)November 8, 2018
Actual (reported)July 2, 2020
Actual (reported)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
until complete regression of motor block (up to 4 hours)
Time to Successful Anesthesia (Successful Sensory Block)
From spinal injection of the local anesthetic to bilateral T4 level (average 20 minutes)
Number of Participants Per Maximal Level of Sensory Block Attained After Spinal Anesthesia
until complete release of sensory block (T12-S1) (average 4 hours)
Time to Resolution of Sensory Block
until complete release of sensory block (T12-S1) (average 4 hours)
Time to Motor Block Onset
From spinal injection of the local anesthetic to bilateral T4 level and during surgery (average 1 hour)
Number of Patients With Hypotension and Use of Vasopressors
up to 2 hours after surgery
Hyperbaric bupivacaine 0.5% will be administered at the dose of 10 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.
Hyperbaric prilocaine 2% will be administered at the dose of 50 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.
The dose of 10 mg of hyperbaric bupivacaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.
The dose of 50 mg of hyperbaric prilocaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.
University Hospital Saint-Pierre, Université Libre de Bruxelles (ULB)
Brussels, Brussels Capital, 1000, Belgium
Clinique Ste-Anne/St-Remi
Anderlecht, 1070, Belgium
Gautier P, De Kock M, Huberty L, Demir T, Izydorczic M, Vanderick B. Comparison of the effects of intrathecal ropivacaine, levobupivacaine, and bupivacaine for Caesarean section. Br J Anaesth. 2003 Nov;91(5):684-9. doi: 10.1093/bja/aeg251.
Guntz E, Latrech B, Tsiberidis C, Gouwy J, Kapessidou Y. ED50 and ED90 of intrathecal hyperbaric 2% prilocaine in ambulatory knee arthroscopy. Can J Anaesth. 2014 Sep;61(9):801-7. doi: 10.1007/s12630-014-0189-7. Epub 2014 Jun 7.
Panayota KAPESSIDOU, MD, PhD
University Hospital Saint-Pierre (CHU Saint-Pierre), Université Libre de Bruxelles (ULB)
Philippe GOFFARD, MD
University Hospital Saint-Pierre (CHU Saint-Pierre), Université Libre de Bruxelles (ULB)
40 participants (actual enrollment reported by the registry).
First Submitted
July 25, 2016
First Posted
November 25, 2016
Study Start
March 12, 2018
Actual (reported)Estimation of the ED95 of Intrathecal Hyperbaric Prilocaine 2% With Sufentanyl for Scheduled Cesarean Delivery
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Guntz E, Kapessidou Y. Spinal prilocaine for same-day surgery: the importance of equipotent doses. Can J Anaesth. 2016 Aug;63(8):985-6. doi: 10.1007/s12630-016-0645-7. Epub 2016 Apr 4. No abstract available.
Goffard P, Leloup R, Vercruysse Y, Fils JF, Gautier PE, Kapessidou Y. Comparison of equipotent doses of intrathecal hyperbaric prilocaine 2% and hyperbaric bupivacaine 0.5% for elective caesarean section: A prospective, randomised, controlled, two-centre clinical trial. Eur J Anaesthesiol. 2022 Mar 1;39(3):227-235. doi: 10.1097/EJA.0000000000001548.
Primary Completion
November 8, 2018
Actual (reported)Study Completion
November 8, 2018
Actual (reported)Last Updated
July 2, 2020
Results First Posted
July 2, 2020
Record last verified: 2020-07
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Source: ClinicalTrials.gov.
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