Pain Clinical Trial
Official title:
Levobupivacïne Into Post-analgesia : Randomized Monocentric Study Against Placebo
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
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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