Study : LEVOBUPIVACAINE Versus Placebo

Pain Clinical Trial

— LEVOBU  

Official title:

Levobupivacïne Into Post-analgesia : Randomized Monocentric Study Against Placebo

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00621907
• Other study ID #: 0708097
• Secondary ID: 2007-006275-36
• Status: Completed
• Phase: Phase 3
• First received: February 11, 2008
• Last updated: September 15, 2010
• Start date: March 2008
• Est. completion date: May 2009

Study information

• Verified date: September 2010
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: French Data Protection Authority
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• chirocaine (Levobupivacaine)
levobupivacaine 0,5 % 30 ml infiltration (150 mg)
• sodium chloride
sodium chloride : 0,9% 30 ml

Locations

Country	Name	City	State
France	University Hospital	Saint-Etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	analgesic consumption of level 3 in the two treated groups		24 hours	Yes
Secondary	visual analogic scale (VAS) at rest or on rising, early rehabilitation, residual pain 2 months after the operation		hours : 1, 2, 3, 4, 5, 6, 8, 12, 24, 48 and at 2 month	Yes