Levobupivacaine for Epidural Analgesia in Labour

• Status: Completed
• Trial end date: 2008-03-01
• Target enrollment: 0
• Participant gender: Female

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Clermont-Ferrand
• Treatments: Bupivacaine; Levobupivacaine

Criteria

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