Mastectomy
Conditions
Brief summary
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.
Interventions
DRUGlidocaine aguettant
Sponsors
Assistance Publique Hopitaux De Marseille
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak Plasma Concentration (Cmax) of 'drug lidocaine'" | 36 MONTHS | during tumescent infiltrative anaesthesia for mastectomy. |
Secondary
| Measure | Time frame |
|---|---|
| analgesic postoperative efficacy | 36 MONTHS |
Countries
France
Contacts
STUDY_DIRECTORBERNARD BELAIGUES
Assistance Publique hôpitaux de Marseille
Outcome results
None listed