The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00621907
Recruitment Status : Completed
First Posted : February 22, 2008
Last Update Posted : September 16, 2010
Information provided by:
Centre Hospitalier Universitaire de Saint Etienne

February 11, 2008
February 22, 2008
September 16, 2010
March 2008
May 2009   (Final data collection date for primary outcome measure)
analgesic consumption of level 3 in the two treated groups [ Time Frame: 24 hours ]
Same as current
Complete list of historical versions of study NCT00621907 on Archive Site
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 ]
Same as current
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Study : LEVOBUPIVACAINE Versus Placebo
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.

Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Drug: chirocaine (Levobupivacaine)
    levobupivacaine 0,5 % 30 ml infiltration (150 mg)
  • Drug: sodium chloride
    sodium chloride : 0,9% 30 ml
  • Experimental: 1
    patient who received levobupivacaïne
    Intervention: Drug: chirocaine (Levobupivacaine)
  • Placebo Comparator: 2
    patient who received placebo
    Intervention: Drug: sodium chloride
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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
May 2009
May 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years to 50 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Clément CAILLAUX, Centre Hospitalo-Universitaire de Saint-Etienne
Centre Hospitalier Universitaire de Saint Etienne
Not Provided
Principal Investigator: Céline CHAULEUR, MD CHU de Saint-Etienne
Centre Hospitalier Universitaire de Saint Etienne
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP