Clinical trial NCT00621907: Study : LEVOBUPIVACAINE Versus Placebo
Official title: Levobupivacïne Into Post-analgesia : Randomized Monocentric Study Against Placebo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Keywords: randomized
analgesic
caesarean scars
locoregional anaesthesia
infiltration
levobupivacaïne
Chirocaïne
caesarian
unique administration
post-caesarian analgesic
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2008-02-22
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: analgesic consumption of level 3 in the two treated groups
timeFrame: 24 hours
Secondary outcomes:
measure: visual analogic scale (VAS) at rest or on rising, early rehabilitation, residual pain 2 months after the operation
timeFrame: hours : 1, 2, 3, 4, 5, 6, 8, 12, 24, 48 and at 2 month
Other outcomes:
Locations:
city: Saint-Etienne
country: France
facility: University Hospital
Study officials:
affiliation: CHU de Saint-Etienne
name: Céline CHAULEUR, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Corsini T, Cuvillon P, Forgeot A, Chapelle C, Seffert P, Chauleur C. [Single-dose intraincisional levobupivacaine infiltration in caesarean postoperative analgesia: a placebo-controlled double-blind randomized trial]. Ann Fr Anesth Reanim. 2013 Jan;32(1):25-30. doi: 10.1016/j.annfar.2012.10.035. Epub 2012 Dec 21. French.