evobupivacaine into post-caesarian analgesia: randomized monocentric study against placebo - LEVOB

Conditions: post-caesarean analgesia
MedDRA version: 9.1Level: LLTClassification code 10006924Term: Caesarean section
MedDRA version: 9.1Level: LLTClassification code 10021415Term: Immediate postoperative analgesia

Registration Number: EUCTR2007-006275-36-FR

Lead Sponsor: CHU de Saint-Etienne

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Female

Target Recruitment: Not specified

Inclusion Criteria

- patient requiring a non-urgent caesarean done according to the Misgav-Ladach technique
- patient affiliated to a social security system
- Sign a written inform consent
- Women
- age equal or superior 18 years
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- patient requiring very urgent caesarean
- patient with a previous history of alcoholism or drug addiction
- patient with severe hypotension or an ischemic cardiopathy badly compensated or thyrotoxicoses
- patient treated with the first generation of IMAO (monoamine oxidase inhibitor) or with anti-arrhythmia drugs with a local anesthesic activity

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: comparison of analgesic consumption of level 3 in two treated groups (levobupivacaine versus placebo);Secondary Objective: comparison of : <br>- VAS (visual analogic scale) at rest or on rising<br>- early rehabilitation<br>- residual pain 2 months after the operation<br>;Primary end point(s): analgesic consumption of level 3 in the two treated groups (levobupivacaine versus placebo)

Secondary Outcome Measures