Working... Menu

Lidocaine Pharmacokinetics During Tumescent Infiltrative Anaesthesia for Mastectomy

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. Identifier: NCT01687348
Recruitment Status : Completed
First Posted : September 18, 2012
Last Update Posted : January 25, 2016
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

Brief Summary:

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 or disease Intervention/treatment Phase
Mastectomy Drug: lidocaine aguettant Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Lidocaine Pharmacokinetics During Tumescent Infiltrative Anaesthesia for Mastectomy.
Study Start Date : November 2012
Actual Primary Completion Date : November 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mastectomy

Arm Intervention/treatment
Experimental: lidocaine
lidocaine traitment
Drug: lidocaine aguettant

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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)

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 identifier (NCT number): NCT01687348

Layout table for location information
Assistance Publique Hopitaux de Marseille
Marseille, France, 13354
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Layout table for investigator information
Study Director: BERNARD BELAIGUES Assistance Publique hôpitaux de Marseille

Layout table for additonal information
Responsible Party: Assistance Publique Hopitaux De Marseille Identifier: NCT01687348     History of Changes
Other Study ID Numbers: 2012-000817-36
2012-05 ( Other Identifier: AP HM )
First Posted: September 18, 2012    Key Record Dates
Last Update Posted: January 25, 2016
Last Verified: September 2015

Additional relevant MeSH terms:
Layout table for MeSH terms
Anesthetics, Local
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