Safety and Efficacy of Intraoperative Continuous Lidocaine Infusion in Patients Undergoing Laparoscopic Liver Surgery: Effects on Postoperative Pain, Gut Function and Insulin Resistance
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 94
- 主要终点
- opioid consumption during the first 24 hours after the surgery
研究概览
简要总结
The goal of this clinical trial is to learn about effect of intraoperative continuous lidocaine infusion on postoperative pain, gut function and insulin resistance in patients undergoing laparoscopic liver surgery in adults. It will also learn about the safety of this infusion in this setting. The main questions it aims to answer are: does the intraoperative continuous systemic lidocaine infusion lower the opioid consumption 24h after surgery? Is the time to first flatus after surgery reduced? Is there increases in insulin resistance after intraoperative lidocaine infusion? Researchers will compare intraoperative continuous systemic lidocaine infusion to a placebo (a look-alike substance that contains no drug, which will be normal saline administered at the same volume, infusion rate and timing) to see if intraoperative continuous systemic lidocaine infusion reduces postoperative pain after laparoscopic liver resection.
Participants will receive intraoperative continuous systemic lidocaine infusion or placebo. Clinical assessment will be based on gathering data of NRS scores after the surgery, time to first flatus or stool. How much opioids the patients need in the first 3 postoperative days. Laboratory assessment will include the evaluation of fasting blood glucose concentration and insulin levels preoperatively and on 1, 2 and 3 postoperative days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age >18 years old
- •patients scheduled for laparoscopic liver surgery
- •patients classified as American Society of Anesthesiology (ASA) physical status I- III
排除标准
- •medical history of seizure disorders
- •allergy to Lidocaine
- •cardiac rhythm disorders (e.g. sick sinus syndrome, Adams-Stockes syndrome, II- and III-degree AV blocks, double- bundle branch block, HR < 50/min)
- •systolic heart failure (ejection fraction <50%)
- •hepatic dysfunction (aspartate aminotransferase or alanine transaminase or total bilirubin >2.5 times the upper limit of normal)
- •renal impairment (GFR < 50ml/min/1.73 m2)
- •weight less than 45 kg, BMI > 30
- •metastases occurring in other distant organs
- •recent use of any analgesic medication within 48h before surgery
- •history of alcohol or substance abuse
- •chronic pain syndrome
- •chronic opioid use
- •inability to comprehend NRS or complete questionnaires due to language barrier or cognitive impairment
研究组 & 干预措施
The lidocaine group
干预措施: lidocaine infusion (Drug)
The placebo group
干预措施: Placebo (Other)
结局指标
主要结局
opioid consumption during the first 24 hours after the surgery
时间窗: First 24 hours after the end of the surgery (extubation)
the mean cumulative opioid consumption during the first 24 hours after the surgery
次要结局
- gut recovery(from the end of the surgery (extubation) until the date of first documented flatus or stool, whichever came first, assessed up to 72 hours)
- HOMA-IR(from the day 0 after surgery to day 3 after surgery)