Study : LEVOBUPIVACAINE Versus Placebo

Centre Hospitalier Universitaire de Saint Etienne

Status and phase

Completed

Phase 3

Conditions

Pain

Treatments

Drug: chirocaine (Levobupivacaine)

Drug: sodium chloride

Study type

Interventional

Funder types

Other

Identifiers

NCT00621907

2007-006275-36

0708097

Details and patient eligibility

About

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

Full 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.

Enrollment

140 patients

Sex

Female

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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