A Phase 3 interventional study of chirocaine (Levobupivacaine) and sodium chloride in Pain, sponsored by Centre Hospitalier Universitaire de Saint Etienne. Completed at 1 site in France. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2010-09-16.
Sponsored by Centre Hospitalier Universitaire de Saint Etienne · Phase 3, Interventional, and Treatment
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.
2,450 studies on the registry are indexed under Pain; 945 are open to participants now.
This study's enrollment of 140 is above the median of 70 across 2,101 interventional studies indexed under Pain.
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Exclusion Criteria:
patient who received levobupivacaïne
Drug: chirocaine (Levobupivacaine)
patient who received placebo
Drug: sodium chloride
levobupivacaine 0,5 % 30 ml infiltration (150 mg)
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
This study is completed, as verified in Sep 2010. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Levobupivacaine
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