Lidocaine Pharmacokinetics During Tumescent Infiltrative Anaesthesia for Mastectomy.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Peak Plasma Concentration (Cmax) of 'drug lidocaine'"
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Surgery carcinologique of the breast requiring a mastectomy under tumescente local anesthetic
- •Age: upper to 18 years
- •Weight: upper to 50 kg
排除标准
- •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)
研究组 & 干预措施
lidocaine
lidocaine traitment
干预措施: lidocaine aguettant (Drug)
结局指标
主要结局
Peak Plasma Concentration (Cmax) of 'drug lidocaine'"
时间窗: 36 MONTHS
during tumescent infiltrative anaesthesia for mastectomy.
次要结局
- analgesic postoperative efficacy(36 MONTHS)