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临床试验/NCT01395043
NCT01395043已完成不适用

TAP-catheter With Intermittent Bolus Injections of Bupivacain, an Alternative to Epidural Catheter Infusion After Colon Surgery?

Aalborg University Hospital1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2010年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
15
试验地点
1
主要终点
Postoperative Pain Using Numerical Rating Scale (NRS) 0-10

研究概览

简要总结

Major abdominal surgery is associated with postoperative pain. Transversus Abdominis Plane(TAP) block has been shown to reduce pain and opioid-requirements after abdominal surgery. However a single block has a short effect of up to 12 hours depending on the type local-anesthetics used.

With this study we wish to investigate the possibilities to place a TAP-catheter in order to prolong the the effect of the TAP-block by giving repeatedly bolus-injections in the TAP catheter and to study the pain and the opioid requirements of patients undergoing elective colon-resection when given a TAP-catheter preoperatively.

Our hypothesis is that it is practical and technical possible to place bilateral TAP-catheters pre-operatively and that pain and opioid-requirements will be low.

详细描述

Postoperative pain is a major challenge in the work of anesthesia. Epidural catheter is the golden standard for postoperative pain management after major abdominal surgery. However a number of patient have absolute or relative contraindication to the placement of an epidural catheter. It is therefore necessary to find a good alternative to epidural catheter.

Transversus abdominis plane(TAP) block has been shown to provide analgesia of the abdominal wall and reduce opioid-requirements and pain after abdominal surgery.

However the effect of a TAP block is limited to the time of efficacy of the local analgesic used. Placing a TAP-catheter in order to prolong the effect of the TAP-block by repeatedly bolus-injections in the TAP-catheters has only been sporadically described and so far never investigated in a systematic way.

We will investigate the practical and technical possibility to place bilateral ultrasound-guided TAP-catheters pre-operatively on patients undergoing elective colon-resection. Further more we will evaluate the pain and opioid-requirement postoperatively.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • elective open colon-resection
  • written and informed consent

排除标准

  • re-operation within the first 48 hours
  • need for sedation and ventilator-support postoperatively
  • accidental removal of catheter within the first 24 hours

研究组 & 干预措施

TAP-catheter

Other

Each patient receives bilateral TAP-catheters preoperatively.

干预措施: Placing bilateral TAP-catheters preoperatively (Procedure)

TAP-catheter

Other

Each patient receives bilateral TAP-catheters preoperatively.

干预措施: Bupivacain 2.5 mg/ml with epinephrine bolus in TAP-catheters (Drug)

结局指标

主要结局

Postoperative Pain Using Numerical Rating Scale (NRS) 0-10

时间窗: 0-36 hours postoperative

NRS is a pain score and the score can vary between 0 and 10 by which 0 means no pain and 10 equals the worst possible pain. NRS was evaluated at the time 0, 1, 2, 4, 8 , 12, 18 , 24 and 36 hours after arriving in the post anesthesia care unit at rest and during coughing.

次要结局

  • Opioid Requirements Postoperative(48 hours from arriving in the post anesthesia care unit.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nils Bjerregaard

Departement of anesthesia

Aalborg University Hospital

研究点 (1)

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