Effect of Perioperative Lidocaine on Gastrointestinal Function Recovery After Lumbar Spine Surgery in Adults: a Multicenter, Randomized, Double-blind, Controlled Study
试验速览
- 阶段
- 不适用
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- First anal exhaust time
研究概览
简要总结
Spinal surgery often involves multiple segments. The trauma of surgery is large, the duration of postoperative pain is long, and the pain is severe. Therefore, the use of opioids in perioperative period is large. Although the application of * large amounts of opioids can effectively inhibit pain, it will delay the recovery of urine retention, sedation, respiratory depression and gastrointestinal function. The delayed recovery of gastrointestinal function will increase the postoperative complications, and then increase the length of hospital stay and the cost of patients. Therefore, reducing the dosage of opioids to promote the recovery of gastrointestinal function has become the research direction. Intravenous lidocaine has been proved to be effective in reducing the dosage of opioids during the perioperative period of gastrointestinal surgery and promoting the recovery of postoperative gastrointestinal function. However, there are few studies on the application of lidocaine during the perioperative period of spinal surgery, especially the impact on postoperative gastrointestinal function. In this study, a multicenter, randomized, double-blind, controlled study was conducted to explore the effect of perioperative lidocaine on the recovery of gastrointestinal function after adult lumbar surgery. We hypothesized that lidocaine could shorten the recovery time of gastrointestinal function after lumbar surgery
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 60 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 60 to 80;
- •ASA physical status score of I, II or III;
- •Scheduled to undergo a posterior lumbar surgery;
- •Ideal body weight≤80 kg;
排除标准
- •Those who are refused to be included;
- •Those who are allergic to the drugs used in this study;
- •Emergency operation
- •Degree II or III atrioventricular block
- •heart failure
- •History of ALS, preexcitation or active dysrhythmia
- •Severe liver injury (bilirubin > 1.46 mg/dl)
- •Severe renal injury (creatinine clearance < 30 ml/min) or Renal failure
- •History of epilepsy
- •History of porphyria
- •Preoperative hypotension (SBP< 90mmHg)
- •Drug contraindications of NSAIDs
- •Allergic to anaesthetic
研究组 & 干预措施
Experimental: Lidocaine group
干预措施: Lidocain (Drug)
Placebo Comparator: comparator group
干预措施: normal saline (Drug)
结局指标
主要结局
First anal exhaust time
时间窗: Day 0
Time of first anal exhaust after operation
次要结局
- First diet time(Day 0)
- First defecation time(Day 0)
- Time to get out of bed(Day 0)
研究者
Yi Feng, MD
Head of Anesthesiology
Peking University People's Hospital
