A Randomized Double Blind Trial Comparing the Effect of Transversus Abdominal Plane-catheter and Epidural Catheter on Postoperative Pain After Open Gynecologic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Pain-score on numerical rating scale
研究概览
简要总结
This study compares the effect on postoperative pain of bolus administration of ropivacaine in Transversus abdominis plane catheter and continuous bupivacain-infusion in epidural catheters following open gynecologic surgery.The study is double blind. The hypothesis is that the effect of the two modes of pain treatment are equal.
详细描述
Patients for open gynecologic surgery will all receive both an epidural catheter and bilateral transversus abdominis plane (:TAP) catheters. After randomization in to two groups the patients receive either 1) intermittent boluses of ropivacaine in the TAP-catheters and isotonic potassium chloride-infusion i the epidural catheters or 2) intermittent isotonic potassium chloride-boluses i the TAP-catheters and bupivacain-infusion in the epidural catheters.
The investigators record pain-score and consumption of opioids in the first 24 hours postoperatively as well as thermoanalgesia at dermatome-levels th10-th12.
The investigators assume that the effect on postoperative pain after open gynecologic surgery is equal in the two groups.
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 open gynecologic surgery
- •acceptance to participate
排除标准
- •allergies to local analgetics
- •daily use of strong opioids
研究组 & 干预措施
Bupivacain-infusion in epidural catheter
Bupivacain-infusion in epidural catheter and intermittent isotonic potassium chloride bolus in transversus abdominis plane catheter.
干预措施: Bupivacain-infusion in epidural catheter (Drug)
Ropivacaine bolus in transversus abdominis plane catheter
Intermittent ropivacaine bolus in bilateral transversus abdominis plane catheter and isotonic potassium chloride infusion in epidural catheter.
干预措施: Ropivacaine bolus in transversus abdominis plane catheter (Drug)
结局指标
主要结局
Pain-score on numerical rating scale
时间窗: 4 hours after first bolus in tranversus abdominis catheters
次要结局
- Administration of opioids(The first 24 hours after surgery.)
- Pain-score on numerical rating scale(24 hours after first bolus in tranversus abdominis catheters)
研究者
Nils Bjerregaard
Consultant Anesthetist
Aalborg University Hospital