The Safety of Ropivacaine Transversus Abdominis Plane Block Combined With Intravenous Lidocaine in Patients Undergoing Colorectal Cancer Surgery: a Single Center, Open Label Dose Escalation Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- The safety profile of combining ropivacaine and lidocaine
研究概览
简要总结
Many studies have confirmed the analgesic effect of intravenous infusion of lidocaine in abdominal surgery. Transversus abdominis plane (TAP) block is also often recommended for abdominal surgery. Ropivacaine TAP block and intravenous lidocaine infusion are important components of multimodal analgesia for colorectal surgery. However, both of them are the local anesthetics and the safety of combination is unknown, so investigators design the study to explore the safety of the synergistic application of ropivacaine TAP block and intravenous lidocaine infusion in patients undergoing colorectal surgery.
详细描述
Transversus abdominis plane (TAP) block is often recommended for abdominal surgery. Ropivacaine TAP block and intravenous lidocaine infusion are important components of multimodal analgesia for colorectal surgery. However, both of them are the local anesthetics and the safety of combination is unknown, so investigators design the study to explore the safety of the synergistic application of ropivacaine TAP block and intravenous lidocaine infusion in patients undergoing colorectal surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 18 and 65 years;
- •Patients who plan to undergo open/laparoscopic colorectal cancer resection surgery under general anesthesia;
- •American society of Anesthesiologists (ASA) physical status classification system I~II;
排除标准
- •Weight less than 40kg or more than 100kg;
- •Defects in the cardiac conduction system (II or III degree atrioventricular block) or cardiac dysfunction (LVEF<50%);
- •Severe liver dysfunction (ALT, AST, bilirubin 2.5 times higher than normal), renal dysfunction (creatinine clearance rate<60ml/min);
- •Allergies to experimental drugs;
- •Patients who are unable to communicate;
- •Participating in other clinical researchers.
研究组 & 干预措施
ropivacaine
Patients will receive a TAP block using 1.5 mg/kg, 2.0 mg/kg or 2.5 mg/kg of ropivacaine. If there is no LAST (local anesthetic systemic toxicity) in the three subjects of 1.5 mg/kg group, the next three patients will receive 2.0 mg/kg of ropivacaine. Another three patients will receive 2.5 mg/kg of ropivacaine if there is no LAST in the three subjects of 2.0 mg/kg group. All subjects will be administered an i.v. bolus of lidocaine 2.0 mg/kg (given as an infusion for 10 min) after anaesthesia induction, then continuous infusion at 2 mg/kg/h until the end of surgery.
干预措施: Ropivacaine Hydrochloride 10 MG/ML [Naropin] (Drug)
结局指标
主要结局
The safety profile of combining ropivacaine and lidocaine
时间窗: From administration of ropivacaine or lidocaine to postoperative 24 hours
To observe signs of LAST, such as dizziness, light-headedness, metallic taste, peri-oral numbness, seizure activity or tinnitus, new-onset ECG irregularities, or intraoperative spike wave of EEG, et al.
次要结局
- The plasma concentration of ropivacaine(From 10 min to 24h after the completion of bilateral TAP block)
- The plasma concentration of lidocaine(From 10 min to 24h after the initiation of IV lidocaine.)
研究者
Chunling Jiang
Professor
West China Hospital