Comparing the Effect of TAP-catheter and Epidural Catheter on Postoperative Pain After Open Gynecologic Surgery
A Randomized Double Blind Trial Comparing the Effect of Transversus Abdominal Plane-catheter and Epidural Catheter on Postoperative Pain After Open Gynecologic Surgery
研究概览
地位
条件
详细说明
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.
研究类型
阶段
- 不适用
联系人和位置
学习地点
-
-
Region Nord
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Aalborg、Region Nord、丹麦、9000
- Aalborg Hospital
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- patients scheduled for open gynecologic surgery
- acceptance to participate
Exclusion Criteria:
- allergies to local analgetics
- daily use of strong opioids
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Bupivacain-infusion in epidural catheter
Bupivacain-infusion in epidural catheter and intermittent isotonic potassium chloride bolus in transversus abdominis plane catheter.
|
Isotonic potassium chloride, 10-25 ml in each transversus abdominis catheter, depending on patient weight. Bolus is given every 6 hours, the first bolus is given just after induction of general anesthesia and the last bolus after 24 hours. In the epidural catheter a bolus of 8 ml bupivacaine 2,5 mg/ml is given and an infusion of isotonic potassium chloride, 4-7 ml/t depending on patient height is started and runs for the first 24 hours |
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有源比较器：Ropivacaine bolus in transversus abdominis plane catheter
Intermittent ropivacaine bolus in bilateral transversus abdominis plane catheter and isotonic potassium chloride infusion in epidural catheter.
|
Ropivacaine 7,5 mg/ml, 10-25 ml in each catheter, depending on patient weight, the total dose of ropivacaine is kept less than 3 mg/kg for every bolus. Bolus is given every 6 hours, the first bolus is given just after induction of general anesthesia and the last bolus after 24 hours. In the epidural catheter a bolus of 8 ml isotonic potassium chloride is given and an infusion of isotonic potassium chloride, 4-7 ml/t depending on patient height is started and runs for the first 24 hours. |
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Pain-score on numerical rating scale
大体时间：4 hours after first bolus in tranversus abdominis catheters
|
4 hours after first bolus in tranversus abdominis catheters
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
阿片类药物的管理
大体时间：手术后第一个 24 小时。
|
手术后第一个 24 小时。
|
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Pain-score on numerical rating scale
大体时间：8 hours after first bolus in tranversus abdominis catheters
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8 hours after first bolus in tranversus abdominis catheters
|
|
Pain-score on numerical rating scale
大体时间：24 hours after first bolus in tranversus abdominis catheters
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24 hours after first bolus in tranversus abdominis catheters
|
其他结果措施
结果测量 |
大体时间 |
|---|---|
|
Thermoanalgesia at dermatome-level th10-th12
大体时间：4 hours after first bolus in TAP-catherter
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4 hours after first bolus in TAP-catherter
|
合作者和调查者
调查人员
- 首席研究员：Nils F Bjerregaard, M.D.、Aalborg University Hospital
- 研究主任：Bodil S Rasmussen, M.D. + PhD、Aalborg Sygehus
- 学习椅：Lone Nikolajsen, M.D, PhD、Aarhus University Hospital
- 学习椅：Thomas F Bendtsen, MD, PhD、Aarhus University Hospital
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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