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Lidocaine Pharmacokinetics During Tumescent Infiltrative Anaesthesia for Mastectomy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01687348
First Posted: September 18, 2012
Last Update Posted: January 25, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille
  Purpose

Prospective, monocentric, open-label study conducted in women requiring mastectomy and eligible for tumescent infiltrative anaesthesia.

Blood samples will be collected during 48h after start of infiltration. Total and free lidocaine concentrations measurements will be determined by gas chromatography. Visual analogic scale scores to evaluate postoperative pain and all data concerning analgesic drugs and adverse effects will be collected.

Population pharmacokinetic parameters will be estimated using NONMEM software and covariates influence on parameters variability will be tested.

Primary outcome value: Population pharmacokinetic parameters with possible covariates influence on variability.

Patients and period of study: n=30 patients enrolled during 24 months, total study duration: 30 months.


Condition Intervention Phase
Mastectomy Drug: lidocaine aguettant Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Lidocaine Pharmacokinetics During Tumescent Infiltrative Anaesthesia for Mastectomy.

Resource links provided by NLM:


Further study details as provided by Assistance Publique Hopitaux De Marseille:

Primary Outcome Measures:
  • Peak Plasma Concentration (Cmax) of 'drug lidocaine'" [ Time Frame: 36 MONTHS ]
    during tumescent infiltrative anaesthesia for mastectomy.


Secondary Outcome Measures:
  • analgesic postoperative efficacy [ Time Frame: 36 MONTHS ]

Estimated Enrollment: 30
Study Start Date: November 2012
Study Completion Date: December 2015
Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: lidocaine
lidocaine traitment
Drug: lidocaine aguettant

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Surgery carcinologique of the breast requiring a mastectomy under tumescente local anesthetic
  • Age: upper to 18 years
  • Weight: upper to 50 kg

Exclusion Criteria:

  • Cutaneous infection in the point of draining
  • Clinical Disorder(Confusion) of the coagulation
  • Retreat(Withdrawal) of the consent in the course of protocol
  • Unwanted Effect engraves(burns) requiring the stop(ruling) of the treatment(processing)
  Contacts and Locations
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): NCT01687348


Locations
France
Assistance Publique Hopitaux de Marseille
Marseille, France, 13354
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Study Director: BERNARD BELAIGUES Assistance Publique hôpitaux de Marseille
  More Information

Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT01687348     History of Changes
Other Study ID Numbers: 2012-000817-36
2012-05 ( Other Identifier: AP HM )
First Submitted: June 20, 2012
First Posted: September 18, 2012
Last Update Posted: January 25, 2016
Last Verified: September 2015

Additional relevant MeSH terms:
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action