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Pharmacokinetic of levobupivacaïne After Sciatic Nerve Block in Children

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ClinicalTrials.gov Identifier: NCT00682344
Recruitment Status : Terminated
First Posted : May 22, 2008
Last Update Posted : August 28, 2014
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

Brief 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).

Condition or disease Intervention/treatment Phase
Surgical Pathology of the Leg or the Foot. Drug: Levobupivacaïne Phase 3

Detailed 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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Pharmacokinetic of levobupivacaïne After Sciatic Nerve Block in Children
Study Start Date : January 2008
Primary Completion Date : January 2012
Study Completion Date : January 2012

Intervention Details:
    Drug: Levobupivacaïne
    1,75mg/kg


Primary Outcome Measures :
  1. 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. [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. 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. [ Time Frame: 24 months ]


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Ages Eligible for Study:   6 Months to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00682344


Locations
France
Hôpital de la Timone - Pôle d'anesthésie réanimation pédiatrique
Marseille, France, 13005
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Principal Investigator: Frédéric LACROIX, MD ASSISTANCE PUBLIQUE DES HOPITAUX DE MARSEILLE

Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT00682344     History of Changes
Other Study ID Numbers: 2007-000796-42
2007-08
First Posted: May 22, 2008    Key Record Dates
Last Update Posted: August 28, 2014
Last Verified: August 2014

Additional relevant MeSH terms:
Levobupivacaine
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents