Lidocaine Pharmacokinetics During Tumescent Infiltrative Anaesthesia for Mastectomy

May 4, 2026 updated by: Assistance Publique Hopitaux De Marseille

Lidocaine Pharmacokinetics During Tumescent Infiltrative Anaesthesia for Mastectomy.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Marseille, France, 13354
        • Assistance Publique Hopitaux de Marseille

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: lidocaine
lidocaine traitment
Drug: lidocaine aguettant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peak Plasma Concentration (Cmax) of 'drug lidocaine'"
Time Frame: 36 MONTHS
during tumescent infiltrative anaesthesia for mastectomy.
36 MONTHS

Secondary Outcome Measures

Outcome Measure
Time Frame
analgesic postoperative efficacy
Time Frame: 36 MONTHS
36 MONTHS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique Hopitaux De Marseille

Investigators

  • Study Director: BERNARD BELAIGUES, Assistance Publique Hopitaux de Marseille

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

February 28, 2017

Study Registration Dates

First Submitted

June 20, 2012

First Submitted That Met QC Criteria

September 17, 2012

First Posted (Estimated)

September 18, 2012

Study Record Updates

Last Update Posted (Actual)

May 8, 2026

Last Update Submitted That Met QC Criteria

May 4, 2026

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-000817-36
  • 2012-05 (Other Identifier: AP HM)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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