drugset / Trial / NCT00929682

Levobupivacaine for Epidural Analgesia in Labour

NCT00929682

Phase 4 Completed 136 enrolled University Hospital, Clermont-Ferrand
RandomizedParallel-groupDouble-blind

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

Timeline

Start
2007-06
Primary completion
2008-03
Completion
2008-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Levobupivacaine Other / unclassified 0.568 mg/ml Other
Subject Levobupivacaine Other / unclassified 1.136 mg/ml Other
Background Sufentanil Other / unclassified 0.45 ug/ml Other

Indications

No indication recorded.