Lidocaine Pharmacokinetics During Tumescent Infiltrative Anaesthesia for Mastectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2015-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Mastectomy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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lidocaine

lidocaine traitment

Group Type EXPERIMENTAL

lidocaine aguettant

Intervention Type DRUG

Interventions

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lidocaine aguettant

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No