Bupivacaine Pharmacokinetics in Children Following Transversus Abdominis Plane Block
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Population pharmacokinetics of bupivacaine and the influence of patient covariates on drug disposition
研究概览
简要总结
The aims of this study are to determine population PK parameters of bupivacaine in children following TAP block using a population-based PK approach, and to evaluate the influence of patient covariates on drug disposition.
详细描述
The number of published pediatric studies on the use of transversus abdominis plane (TAP) block has increased in recent years. The transversus abdominis plane (TAP) block has been used for postoperative analgesia for surgery to the abdominal wall and involves the injection of local anesthetic solution into a plane between internal oblique (IO) and transversus abdominis (TA) muscles. The TAP block has the advantage of providing unilateral analgesia in instances of non-midline abdominal incision and is particularly useful in cases where epidural blockade is either contraindicated or technically or logistically not feasible. Bupivacaine and ropivacaine have been used as local anesthetics for TAP blocks in published studies to date. However, no data exist regarding the pharmacokinetics of bupivacaine after TAP block in children. The aims of this study are to determine population pharmacokinetic (PK) parameters of bupivacaine in children following a TAP block, using a population-based PK approach.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients receiving a TAP block as part of routine anesthetic management
- •Patients older than 3 months and less than 18 years of age
- •Patients weighing ≥ 6 kg
- •Patients with American Society of Anesthesiologists (ASA) score 1-3
排除标准
- •Patients with known severe preexisting liver disease
- •Patients with known severe (i.e. requiring dialysis) preexisting renal disease
- •Patients who will be discharged the day of surgery
- •Refusal to consent
结局指标
主要结局
Population pharmacokinetics of bupivacaine and the influence of patient covariates on drug disposition
时间窗: 0 - 360 minutes after the TAP block is performed
Blood will be drawn from an indwelling intravenous catheter. Each patient will have a total of 6 samples collected during each of the following time blocks: 0 - 10 minutes, 11 - 20 minutes, 21 - 30 minutes, 31 - 60 minutes, 61 - 180 minutes and 181 - 360 minutes after the TAP block is performed. Age, weight, sex, concomitant drugs (intravenous and inhalation anesthetics, muscle relaxants, and opioids), and kidney function data will be investigated as co-variables for each of the primary parameters. We will obtain estimates of total clearance (CL), volume of distribution, elimination half life (t1/2), estimates of clearance, and absorption rate constant.
次要结局
未报告次要终点
研究者
Jason Hayes
Staff Anesthesiologist
The Hospital for Sick Children