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
  Purpose

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 Intervention Phase
Pain
Drug: chirocaine (Levobupivacaine)
Drug: sodium chloride
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Levobupivacïne Into Post-analgesia : Randomized Monocentric Study Against Placebo

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Saint Etienne:

Primary Outcome Measures:
  • analgesic consumption of level 3 in the two treated groups [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 140
Study Start Date: March 2008
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00621907

Locations
France
University Hospital
Saint-Etienne, France, 42055
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Investigators
Principal Investigator: Céline CHAULEUR, MD CHU de Saint-Etienne
  More Information

No publications provided by Centre Hospitalier Universitaire de Saint Etienne

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Clément CAILLAUX, Centre Hospitalo-Universitaire de Saint-Etienne
ClinicalTrials.gov Identifier: NCT00621907     History of Changes
Other Study ID Numbers: 0708097, 2007-006275-36
Study First Received: February 11, 2008
Last Updated: September 15, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: French Data Protection Authority

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
randomized
analgesic
caesarean scars
locoregional anaesthesia
infiltration
levobupivacaïne
Chirocaïne
caesarian
unique administration
post-caesarian analgesic

Additional relevant MeSH terms:
Levobupivacaine
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 23, 2014