post-caesarean analgesia MedDRA version: 9.1 Level: LLT Classification code 10006924 Term: Caesarean section MedDRA version: 9.1 Level: LLT Classification code 10021415 Term: Immediate postoperative analgesia
Conditions
Interventions
Trade Name: Chirocaine
Product Name: levobupivacaine
Pharmaceutical Form: Solution for injection
Pharmaceutical form of the placebo: Solution for injection
Sponsors
CHU de Saint-Etienne
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: comparison of analgesic consumption of level 3 in two treated groups (levobupivacaine versus placebo);Secondary Objective: comparison of : - VAS (visual analogic scale) at rest or on rising - early rehabilitation - residual pain 2 months after the operation ;Primary end point(s): analgesic consumption of level 3 in the two treated groups (levobupivacaine versus placebo) | — |
Countries
France
Outcome results
None listed