Pharmacokinetic of levobupivacaïne After Sciatic Nerve Block in Children

Surgical Pathology of the Leg or the Foot. Clinical Trial

Official title:

Pharmacokinetic of levobupivacaïne After Sciatic Nerve Block in Children

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00682344
• Other study ID #: 2007-000796-42
• Secondary ID: 2007-08
• Status: Terminated
• Phase: Phase 3
• First received: May 16, 2008
• Last updated: August 27, 2014
• Start date: January 2008
• Est. completion date: January 2012

Study information

• Verified date: August 2014
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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).

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 12 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Surgical Pathology of the Leg or the Foot.

Intervention

Drug:
• Levobupivacaïne
1,75mg/kg

Locations

Country	Name	City	State
France	Hôpital de la Timone - Pôle d'anesthésie réanimation pédiatrique	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The purpose of this work is to describe the pharmacokinetics characteristics by the levobupivacaine after peripheral block by using the principle of the pharmacology of population, this allowing fewer sampling of blood by patients.		24 months	Yes
Secondary	Appreciation, by the anaesthetist in charge of the patient, of the quality of the "surgical" analgesia during the surgery by: very effective, effective, ineffective. Measure of the delay of appeal of the first one bolus of morphine.		24 months	Yes