Pharmacokinetic of levobupivacaïne After Sciatic Nerve Block in Children

Public Assistance-Hospitals of Marseille (AP-HM)

Status and phase: Terminated; Phase 3

Conditions: Surgical Pathology of the Leg or the Foot.

Treatments: Drug: Levobupivacaïne

Study type: Interventional

Funder types: Other

Identifiers

NCT00682344

2007-000796-42

2007-08

Details and patient eligibility

About

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).

Full 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.

Enrollment: 7 patients

Sex: All

Ages: 6 months to 12 years old

Volunteers: No Healthy Volunteers

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.