Study : LEVOBUPIVACAINE Versus Placebo

Study Overview
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Brief Summary
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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
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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.

Official Title
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Levobupivacïne Into Post-analgesia : Randomized Monocentric Study Against Placebo

Conditions
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Pain

Intervention / Treatment
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* Drug: chirocaine (Levobupivacaine)
* Drug: sodium chloride


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>patient who received levobupivacaïne | Drug: chirocaine (Levobupivacaine)<br>* levobupivacaine 0,5 % 30 ml infiltration (150 mg)<br>|
| Placebo Comparator: 2<br>patient who received placebo | Drug: sodium chloride<br>* sodium chloride : 0,9% 30 ml<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| analgesic consumption of level 3 in the two treated groups |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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randomized, analgesic, caesarean scars, locoregional anaesthesia, infiltration, levobupivacaïne, Chirocaïne, caesarian, unique administration, post-caesarian analgesic