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Completed

NCT Number: NCT01687348

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.

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Key information

Conditions

Mastectomy

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Assistance Publique Hopitaux de Marseille

Marseille, 13354, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

lidocaine aguettant

Drug

Primary outcomes

  1. Peak Plasma Concentration (Cmax) of 'drug lidocaine'"

    Time frame: 36 MONTHS

    during tumescent infiltrative anaesthesia for mastectomy.

Secondary outcomes

  1. analgesic postoperative efficacy

    Time frame: 36 MONTHS

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Official study title

Lidocaine Pharmacokinetics During Tumescent Infiltrative Anaesthesia for Mastectomy.

Important dates

Study start
2012
Primary completion
2015
Study completion
2017
First posted
Sep 18, 2012
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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