Study : LEVOBUPIVACAINE Versus Placebo (LEVOBU)
|ClinicalTrials.gov Identifier: NCT00621907|
Recruitment Status : Completed
First Posted : February 22, 2008
Last Update Posted : September 16, 2010
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
|Condition or disease||Intervention/treatment||Phase|
|Pain||Drug: chirocaine (Levobupivacaine) Drug: sodium chloride||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||140 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Levobupivacïne Into Post-analgesia : Randomized Monocentric Study Against Placebo|
|Study Start Date :||March 2008|
|Actual Primary Completion Date :||May 2009|
|Actual Study Completion Date :||May 2009|
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
- analgesic consumption of level 3 in the two treated groups [ Time Frame: 24 hours ]
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00621907
|Saint-Etienne, France, 42055|
|Principal Investigator:||Céline CHAULEUR, MD||CHU de Saint-Etienne|