Lidocaine Pharmacokinetics During Tumescent Infiltrative Anaesthesia for Mastectomy

Public Assistance-Hospitals of Marseille (AP-HM)

Status and phase: Completed; Phase 3

Conditions: Mastectomy

Treatments: Drug: lidocaine aguettant

Study type: Interventional

Funder types: Other

Identifiers

NCT01687348

2012-000817-36

2012-05 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

lidocaine

Experimental group

Description:

lidocaine traitment

Treatment:

Drug: lidocaine aguettant