drugset / Trial / NCT00983125

Systematic Clonidine for Epidural Analgesia in Labour

NCT00983125

Phase 4 Completed 124 enrolled University Hospital, Clermont-Ferrand
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2009-08
Primary completion
2010-03
Completion
2010-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Clonidine Other / unclassified 150 ug Other

Indications

No indication recorded.