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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

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

Condition or disease Intervention/treatment Phase
Pain Drug: chirocaine (Levobupivacaine) Drug: sodium chloride Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Arm Intervention/treatment
Experimental: 1
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

Primary Outcome Measures :
  1. analgesic consumption of level 3 in the two treated groups [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00621907

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University Hospital
Saint-Etienne, France, 42055
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
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Principal Investigator: Céline CHAULEUR, MD CHU de Saint-Etienne
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Clément CAILLAUX, Centre Hospitalo-Universitaire de Saint-Etienne Identifier: NCT00621907    
Other Study ID Numbers: 0708097
First Posted: February 22, 2008    Key Record Dates
Last Update Posted: September 16, 2010
Last Verified: September 2010
Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
caesarean scars
locoregional anaesthesia
unique administration
post-caesarian analgesic
Additional relevant MeSH terms:
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Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents