Study : LEVOBUPIVACAINE Versus Placebo

This study has been completed.
Sponsor:
Information provided by:
Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:
NCT00621907
First received: February 11, 2008
Last updated: September 15, 2010
Last verified: September 2010

February 11, 2008
September 15, 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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00621907 on ClinicalTrials.gov 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 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Pain
  • 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
140
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
Female
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00621907
0708097, 2007-006275-36
Yes
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