Pharmacokinetic of levobupivacaïne After Sciatic Nerve Block in Children

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

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2012-01-31

Brief Summary

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Levobupivacaïne (Chirocaine®) is a new local anaesthetic recently marketed in France. The goal of this prospective work is to study the pharmacokinetic aspect of this drug after injection around the sciatic nerve (subgluteal way).

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Detailed Description

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The originality of this work is to call upon a modelling of pharmacokinetic by using the principle of the pharmacology of population.

This work also proposes to appreciate a dynamic aspect since data of effectiveness and tolerance will be collected with regular intervals during the first 24 hours after the beginning of the study.

Conditions

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Surgical Pathology of the Leg or the Foot.

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Interventions

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Levobupivacaïne

1,75mg/kg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Surgical pathology of the leg or the foot with garot tyre of thigh
* Age included between 6 months and 12 years
* Status ASA I or II

Exclusion Criteria

* Bilateral or one-sided surgical gesture realized without garot tyre
* Cutaneous infection in the point of draining
* Clinical confusion of the coagulation
* Allergy informed in the local anesthesics of amino-acid class
* Evolutionary neurological pathology of the operated limb
* Renal, respiratory, cardiac or hepatic insufficiency.

Minimum Eligible Age

6 Months

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No