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Study : LEVOBUPIVACAINE Versus Placebo

NCT ID: NCT00621907

Last Updated: 2010-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2009-05-31

Brief Summary

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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

Detailed Description

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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.

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

patient who received levobupivacaïne

Group Type EXPERIMENTAL

chirocaine (Levobupivacaine)

Intervention Type DRUG

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

2

patient who received placebo

Group Type PLACEBO_COMPARATOR

sodium chloride

Intervention Type DRUG

sodium chloride : 0,9% 30 ml

Interventions

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chirocaine (Levobupivacaine)

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

Intervention Type DRUG

sodium chloride

sodium chloride : 0,9% 30 ml

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Centre Hospitalo-Universitaire de Saint-Etienne

Principal Investigators

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Céline CHAULEUR, MD

Role: PRINCIPAL_INVESTIGATOR

CHU de Saint-Etienne

Locations

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University Hospital

Saint-Etienne, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 23260628 (View on PubMed)

Other Identifiers

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2007-006275-36

Identifier Type: -

Identifier Source: secondary_id

0708097

Identifier Type: -

Identifier Source: org_study_id