Study : LEVOBUPIVACAINE Versus Placebo

NCT00621907 | Completed Phase 3 DMC

• 2 other identifiers: 07080972007-006275-36
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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

Conditions

Pain

Keywords

randomized; analgesic; caesarean scars; locoregional anaesthesia; infiltration; levobupivacaïne; Chirocaïne; caesarian; unique administration; post-caesarian analgesic

Outcome Measures

Primary Outcomes (1)

• analgesic consumption of level 3 in the two treated groups

  24 hours

Secondary Outcomes (1)

• 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

Study Arms (2)

1

EXPERIMENTAL

patient who received levobupivacaïne

Drug: chirocaine (Levobupivacaine)

2

PLACEBO COMPARATOR

patient who received placebo

Drug: sodium chloride

Interventions

chirocaine (Levobupivacaine) DRUG

levobupivacaine 0,5 % 30 ml infiltration (150 mg)

1

sodium chloride DRUG

sodium chloride : 0,9% 30 ml

2

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• age \> 18 years
• all patients requiring a non-urgent caesarian done according to the Misgav-Ladach technique

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

University Hospital

Saint-Etienne, 42055, France

Location

Related Publications (1)

• 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.

  PMID: 23260628 DERIVED

MeSH Terms

Conditions

Pain

Interventions

Levobupivacaine; Sodium Chloride

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bupivacaine; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Céline CHAULEUR, MD

  CHU de Saint-Etienne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 11, 2008
• First Posted: February 22, 2008
• Study Start: March 1, 2008
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: September 16, 2010

Record last verified: 2010-09

Locations

FR (1)