A Randomised, Double-blind Study to Evaluate the Effect of Bilateral Dual Transversus Abdominis Plane Block on Postoperative Pain and Plasma Concentration of Ropivacaine After Robotic Assisted Laparoscopic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Pain-score on numerical rating scale
研究概览
简要总结
To evaluate the effects of bilateral dual transversus abdominis plane block on postoperative pain after robotic assited laparoskopic surgery and measure the plasma-level of ropivacain after the bilateral dual transversus abdominis plane block.
详细描述
After randomisation patients for robotic assisted laparoscopic surgery will receive bilateral dual transversus abdominis plane block containing either ropivacain or isotonic potassium chloride.
The investigators will record pain-score, opioid-consumption and sensibility on the abdominal wall in the postoperative periode.
Also a blood sample will be taken at 15, 30, 60, 120 and 240 minutes after the block in order to measure the plasma-level of ropivacain after bilateral dual transversus abdominis plane block.
The investigators assume that there will be significant effect on postoperative pain and that the level of plasma-ropivacain will be acceptable.
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
- •patients scheduled for robotic assisted laparoscopis surgery
- •acceptance to participate
排除标准
- •allergies to local analgetics
- •daily use of strong opioids
研究组 & 干预措施
Ropivacain
Ropicacain 3,75 mg/ml 15 ml x 4 when placing the Bilateral Dual Transverus Abdominis Plane block
干预措施: Ropivacaine (Drug)
Isotonic potassium chloride
Isotonic potassium chloride 15 ml x 4 when placing the bilateral dual transverus abdominis plane block.
干预措施: Isotonic potassium chloride (Drug)
结局指标
主要结局
Pain-score on numerical rating scale
时间窗: 4 hours after surgery
次要结局
- Administration of opioids(The first 24 hours after surgery.)
- Pain-score on numerical rating scale(24 hours after surgery)
研究者
Nils Bjerregaard
Consultant Anestetist
Aalborg University Hospital