Systematic Clonidine for Epidural Analgesia in Labour

Phase 4

Completed

• Conditions: Labour
• Interventions: Drug: Clonidine

• Registration Number: NCT00983125
• Lead Sponsor: University Hospital, Clermont-Ferrand

Brief Summary

In a prospective randomised study involving primiparous women in spontaneous uncomplicated labour with cervical dilatation \< 5 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%), in which 10 mL (50 g) of sufentanil will be added, as well as clonidine (150 µg) in one arm. The final concentration of clonidine in this arm will be 1.35 mg.mL-1. Parturients and midwifes assessing pain during labour will be blinded to the design.

Detailed Description

We recently compared the analgesic effects of the two presentations of levobupivacaine available on the French market, (0.625 and 1.25 mg.mL-1 in pre-filled bags), both with sufentanil. It appeared that the high concentration was more powerful, however leading in some cases to give doses of levobupivacaine superior to the label's recommendations. This indicates to use the low concentration, with a risk of a poorer efficacy. Our aim is to show that efficacy can be restored with a systematic addition of clonidine, which has documented analgesic properties when administered perispinally.

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-09-22
• Study First Submitted QC: 2009-09-22
• Study First Posted: 2009-09-23
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-02
• Last Update Posted: 2013-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 124

Inclusion Criteria

• Parturient is 18 years old
• ASA physical status 1 or 2
• Primiparity
• Singleton
• Gestational age is 36 weeks
• Spontaneous labour with cervical dilatation of 5 cm

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
clonidine	Clonidine	-
no clonidine	Clonidine	-

Primary Outcome Measures

Name	Time	Method
Number of required additional epidural boluses, either self-administered or medically given as a rescue	during labour

Secondary Outcome Measures

Name	Time	Method
Spontaneous pain during labour (on VAS)	during labour
Pain at delivery	at delivery
Pain at post-delivery sutures	at post-delivery sutures
Motor block	during labour
Duration of labour	during labour
Obstetrical events (caesarean section, instrumental delivery)	after delivery

Trial Locations

Locations (1)

CHU Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France