Prilocaine or Bupivacaine for Spinal Anesthesiain Pregnant (Césarcaïne)

Comparison of the Duration of Motor Block After Spinal Anesthesia for Planned Cesarean Sections: Hyperbaric Prilocaïne Versus Hyperbaric Bupivacaine

The planned cesarean section is an intervention with a standard operating time of less than 40 minutes in trained teams. Hyperbaric Bupivacaine is the local anesthetic (LA) reference for these operations. But the duration of its motor block is generally greater than 3 hours. The purpose of this study is to show a reduction in motor block time with hyperbaric Prilocaine by at least 30 minutes, which would allow mothers and their children to return to the maternity ward earlier and thus improve the circulation of patients within the maternity's PACU.

Study Overview

• Status: Unknown
• Conditions: Cesarean
• Intervention / Treatment: Drug: spinal anesthesia

Detailed Description

Prospective study, randomized into two parallel groups (Hyperbaric Prilocaïne versus hyperbaric Bupivacaine), double-blind, monocentric (Clinique Saint Roch in Montpellier).

The number of subjects required is 50 patients, 25 per group.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: christophe DADURE, MD, PhD; Phone Number: 33 467338256; Email: c-dadure@chu-montpellier.fr

Study Locations

• France
  • Montpellier, France, 34295
    • Recruiting
    • Uhmontpellier
    • Contact: Christophe DADURE, MD, phD; Phone Number: 33 467333856; Email: c-dadure@chu-montpellier.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Normal pregnancy
• Scheduled caesarean section
• Non-multiple pregnancy
• Age of patient: 18 years and over
• Height of patient: between 155 and 175 cm
• Affiliated patients or beneficiaries of a Social Security System
• Signature of the patient's consent

Exclusion criteria:

• Patient <18 years
• Pathological pregnancy
• Multiple pregnancy
• Emergency caesarean
• Patients who cannot give informed consent (not French speaking)
• Refusal of the patient
• Contraindications to spinal anesthesia
• Contraindications to Prilocaine
• Contraindications to Bupivacaine

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Hyperbaric Bupivacaine; spinal anesthesia for planned cesarean sections control group	Drug: spinal anesthesia; spinal anesthesia for planned cesarean sections
Active Comparator: Hyperbaric Prilocaïne; spinal anesthesia for planned cesarean sections	Drug: spinal anesthesia; spinal anesthesia for planned cesarean sections

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
duration of motor block	To compare the duration of motor block after spinal anesthesia with hyperbaric Prilocaïne versus hyperbaric Bupivacaine This evaluation is done every 15 min from the entrance to the recovery room (PACU); the motor block stops being evaluated when the modified bromination score reaches 4	up to 6 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The upper sensory level	The upper sensory level obtained 15 minutes after the LA injection	15 minutes after the LA injection
Hypotensive episodes	Hypotensive episodes	1 day
The time between injection and incision	The time between injection and incision	1 day
The duration of the intervention	The duration of the intervention	1 day
The time to return to the standard maternity ward	The time to return to the standard maternity ward	1 day
APGAR score of newborns at birth	APGAR score of newborns at birth. L'APGAR Apgar score is a method to quickly summarize the health of newborn children. The Apgar scale is determined by evaluating the newborn baby on five simple criteria on a scale from zero to two, then summing up the five values thus obtained. The resulting Apgar score ranges from zero to 10. The five criteria are summarized using words chosen to form a backronym (Appearance, Pulse, Grimace, Activity, Respiration). The test is generally done at one and five minutes after birth, and may be repeated later if the score is and remains low. Scores 7 and above are generally normal, 4 to 6 fairly low, and 3 and below are generally regarded as critically low.	1 day
The delay between spinal anesthesia and the first emergency analgesic injection	The delay between spinal anesthesia and the first emergency analgesic injection	1 day
Assessment of pain (VAS)	Pain on arrival and departure of PACU and at 24 hours. Pain will be assessedby VAS (Visual Analogue Scale); Patients rate pain on VAS from 0-10, 0 being no pain and 10 being the worst pain imaginable..	1 day
The delay between spinal anesthesia and the first injection of second-line analgesia	The delay between spinal anesthesia and the first injection of second-line analgesia : delay between spinal anesthesia ans the need of rescue analgesia	1 day
The presence of neuro-sensory disorders within 24 hours postoperatively	The presence of neuro-sensory disorders within 24 hours postoperatively	1 day
The presence of post lumbar puncture syndrome	The presence of post lumbar puncture syndrome	1 day
score de satisfaction	Patient satisfaction score at 24 hours will be assessed by VAS (Visual Analogue Scale); Patients rate satisfaction on VAS from 0-10, 0 being no satisfaction and 10 being total satisfaction	1 day
Statifaction of the Surgeon	The surgeon assessed his satisfaction while the cesarien section. The surgeon satisfaction score at 24 hours will be assessed by VAS (Visual Analogue Scale); Surgeon rate satisfaction on VAS from 0-10, 0 being no satisfaction and 10 being total satisfaction.	1 day

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Collaborators: Hopital Saint Roch
• Investigators: Principal Investigator: christophe DADURE, University Hospital, Montpellier

Publications and helpful links

General Publications

• Chapron K, Sleth JC, Capdevila X, Bringuier S, Dadure C. Hyperbaric prilocaine vs. hyperbaric bupivacaine for spinal anaesthesia in women undergoing elective caesarean section: a comparative randomised double-blind study. Anaesthesia. 2021 Jun;76(6):777-784. doi: 10.1111/anae.15342. Epub 2021 Jan 11.

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2018
• Primary Completion (Anticipated): May 7, 2020
• Study Completion (Anticipated): August 30, 2020

Study Registration Dates

• First Submitted: December 21, 2017
• First Submitted That Met QC Criteria: February 8, 2018
• First Posted (Actual): February 15, 2018

Study Record Updates

• Last Update Posted (Actual): December 11, 2018
• Last Update Submitted That Met QC Criteria: December 10, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Caesarean section; spinal anesthesia; Prilocaïne; motor block
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: UF9859

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: NC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No