Spinal Bupivacaine/Morphine in Laparoscopic Gastro-intestinal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Duration of hospital stay
研究概览
简要总结
The objective of this study is to determine if a single spinal shot of morphine can decrease post-operative opioid-use, and thereby decrease opioid side-effects and lead to a quicker recovery after surgery.
详细描述
We expect that in laparoscopic gastro-intestinal surgery, a single shot spinal with bupicavaine/morphine will result in a better analgesia in hte first 48 hours. Herby the patients will require less systemic opioids, which will decrease the side-effects. Furthermore, we expect the patients to recover quicker and show an earlier mobilisation and a shorter hospital stay.
The objective of this study is to determine if a single spinal shot of morphine can decrease post-operative opioid-use, and thereby decrease opioid side-effects and lead to a quicker recovery after surgery.
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)
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
- •Laparoscopic Gastro-intestinal surgery
排除标准
- •Bariatric surgery, gastric surgery, rectal surgery, kidney failure, aorta-valve stenosis, coagulation disorders, emergency surgery
研究组 & 干预措施
Spinal injection
Patients receive spinal injection Bupivacaine/Morphine
干预措施: Spinal injection bupivacaine/morphine (Drug)
Subcutaneum injection
Placebo subcutaneum injections
干预措施: subcutaneum injection lidocaine (Drug)
结局指标
主要结局
Duration of hospital stay
时间窗: first 48 hours
次要结局
- patient-satisfactory on a 4-point scale(120 hours/ 5 days)
- time to mobilisation(120 hours/ 5 days)
- time to bowel movement(120 hours/ 5 days)
- abdominal compliance during laparoscopy in L/mmHg(The compliance will be measured for the duration of the surgery, an expected average of 2 hours.)
- Difficulty of surgery(The difficulty of surgery will be measured for the duration of the surgery, an expected average of 2 hours)
- the occurence of side-effects (nausea, pruritus, drowsiness)(120 hours/ 5 days)
- use of piritramide by PCIA-pump in mg(48 hours)