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More info
You can access this
clinical trial
if you have
Analgesia, Epidural
and you are
over 18
years old
The primary goal of this phase is to monitor the long-term effects.
The treatment is already on the market.
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The purpose

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 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

Provided treatments

  • Drug: Randomization between two referenced treatments
Tris trial is registered with FDA with number: NCT00929682. The sponsor of the trial is University Hospital, Clermont-Ferrand and it is looking for 136 volunteers for the current phase.
Official trial title: