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Levobupivacaine for Epidural Analgesia in Labour
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
Details
| Lead sponsor | University Hospital, Clermont-Ferrand |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 136 |
| Start date | 2007-06 |
| Completion | 2008-03 |
Conditions
- Analgesia, Epidural
Interventions
- Randomization between two referenced treatments
Primary outcomes
- - Spontaneous pain during labour (on VAS). - Number of required additional epidural boluses, either self-administered or medically given as a rescue. — during labour