Study : LEVOBUPIVACAINE Versus 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
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Levobupivacïne Into Post-analgesia : Randomized Monocentric Study Against Placebo|
- analgesic consumption of level 3 in the two treated groups [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
- visual analogic scale (VAS) at rest or on rising, early rehabilitation, residual pain 2 months after the operation [ Time Frame: hours : 1, 2, 3, 4, 5, 6, 8, 12, 24, 48 and at 2 month ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 2008|
|Study Completion Date:||May 2009|
|Primary Completion Date:||May 2009 (Final data collection date for primary outcome measure)|
patient who received levobupivacaïne
Drug: chirocaine (Levobupivacaine)
levobupivacaine 0,5 % 30 ml infiltration (150 mg)
Placebo Comparator: 2
patient who received placebo
Drug: sodium chloride
sodium chloride : 0,9% 30 ml
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00621907
|Saint-Etienne, France, 42055|
|Principal Investigator:||Céline CHAULEUR, MD||CHU de Saint-Etienne|