Study : LEVOBUPIVACAINE Versus Placebo

Phase 3

Completed

• Conditions: Pain
• Interventions: Drug: chirocaine (Levobupivacaine); Drug: sodium chloride

• Registration Number: NCT00621907
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief Summary

The locoregional anaesthesia is increasingly important in surgical practice, often allowing to simplify per- and post-operative analgesia. caesarian occurs in 20 % of delivery leading to a longer hospitalization because of the pain resulting from the surgery. The Levobupivacaïne (Chirocaïne) administered through catheters placed in the caesarean scars, showed its efficiency in post-operative analgesia.

Method : realization of a double blind prospective randomized study, control versus placebo Purpose : to show that the local administration of a unique dose of analgesia reduce the post-operative pain with a little or non-invasive technique

Detailed Description

The study will be done at the department of Obstétric and gynecology, in the CHU of Saint-Etienne. It will include all patients requiring a caesarean without any contraindication.

All the patients requiring a urgent or a very urgent caesarean will be excluded because a rapid consent can't be obtained and the product preparation can't be done.

Inclusion after information and minimum one hour of time for consideration. Randomization : the teatment group will be randomized according to the patient number : control versus placebo : 70 patients in the group infiltration of levobupivacaïne and 70 patients in the group infiltration of a placebo. Every product will be prepared in a 30 ml syringe filled with levobupivacaïne or 0,9 % sodium chloride depending on the group of randomization. All patients will get their caesarean according to the same technique, then, before the cutaneous close, the product will be injected in the caesarean wall.

Fllow-up : supervision of the pain (morphine consumption, VAS) and of undesirable effects.

Study Timeline

• Study First Submitted: 2008-02-11
• Study First Submitted QC: 2008-02-21
• Study First Posted: 2008-02-22
• Study Start: 2008-03
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Status Verified: 2010-09
• Last Update Submitted: 2010-09-15
• Last Update Posted: 2010-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 140

Inclusion Criteria

• age > 18 years
• all patients requiring a non-urgent caesarian done according to the Misgav-Ladach technique

Exclusion Criteria

• Patients requiring very urgent caesarian
• allergic to levobupivacaïne
• with previous history of alcoholism or drug addiction
• with severe hypotension or an ischemic cardiopathy badly compensated or thyrotoxicoses
• treated with first generation of IMAO (monoamine oxidase inhibitor) or with anti-arrhytmia drugs with anesthesic activity

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	chirocaine (Levobupivacaine)	patient who received levobupivacaïne
2	sodium chloride	patient who received placebo

Primary Outcome Measures

Name	Time	Method
analgesic consumption of level 3 in the two treated groups	24 hours

Secondary Outcome Measures

Name	Time	Method
visual analogic scale (VAS) at rest or on rising, early rehabilitation, residual pain 2 months after the operation	hours : 1, 2, 3, 4, 5, 6, 8, 12, 24, 48 and at 2 month

Trial Locations

Locations (1)

University Hospital; 🇫🇷 Saint-Etienne, France