Hyperbaric Bupivacaine Versus Hyperbaric Prilocaine 2% for Cesarean Section Under Spinal Anesthesia

NCT02973048 | Completed Phase 3 Results

• 1 other identifier: B076201627677
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Pregnant Women; Pain; Hypotension

Keywords

Cesarean delivery; Spinal anesthesia; Local anesthetics

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (21)

• 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

Study Arms (2)

Hyperbaric bupivacaine

PLACEBO COMPARATOR

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.

Drug: Hyperbaric bupivacaine

Hyperbaric prilocaine

ACTIVE COMPARATOR

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.

Drug: Hyperbaric prilocaine

Interventions

Hyperbaric bupivacaine DRUG

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.

Also known as: Marcaine

Hyperbaric bupivacaine

Hyperbaric prilocaine DRUG

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.

Also known as: Tachipri

Hyperbaric prilocaine

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• American Society of Anesthesiologists physical status (ASA) \< III
• Age 18-40 year
• Body Weight \<110 kg
• Height between 160 and 175 cm
• Gestational age\>37 SA
• Elective cesarean delivery
• Singleton pregnancy
• Non complicated pregnancy
• Signed informed consent obtained prior to any study specific assessments and procedures

You may not qualify if:

• Twin pregnancy
• History of 2 cesarean section or more
• Diabetes and gestational diabetes
• Placenta praevia
• Congenital foetal abnormality
• Intrauterine growth retardation
• Patient in labour
• Membrane rupture
• Known allergy to local anaesthetics
• Standard contraindications to neuraxial block.
• Disagreement of the patient
• Neurological impairment
• Gestational low blood pressure
• Pre eclampsia and eclampsia

Sponsors & Collaborators

• Centre Hospitalier Universitaire Saint Pierre: lead

Study Sites (2)

University Hospital Saint-Pierre, Université Libre de Bruxelles (ULB)

Brussels, Brussels Capital, 1000, Belgium

Location

Clinique Ste-Anne/St-Remi

Anderlecht, 1070, Belgium

Location

Related Publications (4)

• 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.

  PMID: 14570791 BACKGROUND

• 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.

  PMID: 24906303 BACKGROUND

• 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.

  PMID: 27044397 BACKGROUND

• 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.

  PMID: 34101713 DERIVED

MeSH Terms

Conditions

Pain; Hypotension

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Panayota Kapessidou
• Organization: Centre Hospitalier Universitaire Saint Pierre

pkapessi@ulb.ac.be

+32.2.535

Study Officials

• Panayota KAPESSIDOU, MD, PhD

  University Hospital Saint-Pierre (CHU Saint-Pierre), Université Libre de Bruxelles (ULB)

  STUDY DIRECTOR

• Philippe GOFFARD, MD

  University Hospital Saint-Pierre (CHU Saint-Pierre), Université Libre de Bruxelles (ULB)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2016
• First Posted: November 25, 2016
• Study Start: March 12, 2018
• Primary Completion: November 8, 2018
• Study Completion: November 8, 2018
• Last Updated: July 2, 2020
• Results First Posted: July 2, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2)