Levobupivacaine for Epidural Analgesia in Labour

Phase 4

Completed

• Conditions: Analgesia, Epidural
• Interventions: Drug: Randomization between two referenced treatments

• Registration Number: NCT00929682
• Lead Sponsor: University Hospital, Clermont-Ferrand

Brief Summary

In a prospective randomised study involving primiparous women in spontaneous uncomplicated labour with cervical dilatation \> 7 cm, epidural analgesia will be given with an initial volume of 20 mL anaesthetic solution, followed by a standardised algorithm of top-up manual injections to achieve analgesia, then by a patient-controlled regimen with 5-mL self-administered boli in addition to a continuous infusion of 5 mL.hr-1. The anaesthetic solution will be levobupivacaine presented in 100-mL bags from the market, 0.0625%, or 0.125%, in which 10 mL (50 µg) of sufentanil will be added. The final concentrations will be 0.568 and 1.136 mg.mL-1 respectively, both with sufentanil 0.45 µg.mL-1. Parturients and midwifes assessing pain during labour will be blinded to the design

Detailed Description

Since epidural analgesia has been developed to relieve labour pain, many solutions have emerged to lower risk / efficacy ratio, by using low-concentrated and/or less toxic local anaesthetics. Levobupicaine emerges as a safer alternative than its racemic parent . It is available on the French market in pre-filled bags with two different concentrations (0.625 and 1.25 mg.mL-1), both indicated for analgesia in postoperative context and in labour, without more precision. Presentation in bags allows preparing once at the initiation of epidural analgesia a solution usable throughout labour, leading the anaesthetist to a univocal choice, mostly following his/her personal beliefs. Our aim is to compare the effects of epidural analgesia under these two presentations. Sufentanil will be added to levobupicaine whatever the concentration used. This trial is conducted in primiparous, in which pain during labour is commonly more resistant to relief.

Study Timeline

• Study Start: 2007-06
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Study First Submitted: 2009-06-26
• Study First Submitted QC: 2009-06-26
• Study First Posted: 2009-06-29
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-02
• Last Update Posted: 2013-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 136

Inclusion Criteria

• Parturient > 18 years old
• ASA physical status 1 or 2
• Primiparity
• Singleton
• Gestational age > 36 weeks
• Spontaneous labour with cervical dilatation > 7 cm

Exclusion Criteria

• Gestational age < 36 weeks

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Levobupivacaine 0.568mg.mL	Randomization between two referenced treatments	-
Levobupivacaine 1.136mg.mL	Randomization between two referenced treatments	-

Primary Outcome Measures

Name	Time	Method
- Spontaneous pain during labour (on VAS). - Number of required additional epidural boluses, either self-administered or medically given as a rescue.	during labour

Secondary Outcome Measures

Name	Time	Method
- Pain at delivery - Pain at post-delivery sutures - Motor block - Duration of labour - Obstetrical events (cesarean, instrumental delivery)	during labour