Mastectomy Clinical Trial
Official title:
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.
n/a
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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