Randomized Double Blind Prospective Investigation of the Effect of Intravenous Lidocaine Infusion on Postoperative Pain Treatment and Bowel Function in Robotic Bowel Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Reduction in morphine consumption
研究概览
简要总结
Single center double blind randomised controlled trial. 60 subjects. Giving lidocaine IV or saline to patients due to robot assisted colorectal surgery. Primary outcome is cumulative morphine consumption at 24 hours.
详细描述
Prospective double blind randomised controlled trial. The investigators are giving lidocaine IV or saline to 60 patients undergoing robot assisted colorectal surgery. Blinding and randomization is done by the hospital pharmacy. Both groups get otherwise the same treatment and a IV PCA (patient controlled administration) morphine pump for objectivisation of opioid consumption. Other outcome measures are NRS (numerical rating score) pain score, PONV (postoperative nausea and vomiting), use of antiemetics and opioid consumption up to 72 hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Pharmacy provides the research medicine, it is not possible to see a difference. The envelopes are "encrypted". The randomization will only be broken in the end.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all patients due to robotic laparoscopic colorectal surgery, > 18years of age, danish speaking
排除标准
- •allergy to lidocain or amid local analgetics, atrioventricular blok, liver- and/or kidney failure, chronic use of opioids or NSAIDS, pregnancy, breastfeeding women, treatment with betablockers, porphyria
研究组 & 干预措施
Lidocain
Patient gets the experimental treatment with IV lidocain 0,5mg/ml, 1,5mg/kg bolus before induction of anesthesia, after that infusion of 1,5mg/kg/h is started and continued until 2 hours after end of surgery.
干预措施: Lidocaine (Drug)
Control
Patients get the same amount in ml and duration as if it was the experimental arm. Only in this arm it is isotonic saline instead.
干预措施: Saline (Drug)
结局指标
主要结局
Reduction in morphine consumption
时间窗: over the first 24 hours
PCA morphine added to PN (per necessitae) morphine, cumulated
次要结局
- PONV(up to 72 hours)
- Reduction in morphine consumption(over the first 72hours)
- Time to bowel function(first 72 hours)
- Use of antiemetics postoperative(first 72 hours)
- time to discharge(up to 72 hours)
研究者
Jan Herzog
M.D.
Odense University Hospital