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临床试验/NCT00682136
NCT00682136已完成1 期

Efficacy of Local Anesthetic TAP Blocks in Providing Pain Relief Following Laparoscopic and Open Abdominal Surgery

Hunter Colorectal Research8 个研究点 分布在 1 个国家目标入组 206 人开始时间: 2008年4月1日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
206
试验地点
8
主要终点
mg/kg of morphine equivalent used by patients post operatively.

研究概览

简要总结

The aim of the study is to establish the efficacy of local anaesthetic TAP (transversus abdominis plane) blocks in providing pain relief in the first 24hrs following open or laparoscopic elective abdominal colorectal operations.

TAP blocks involve the injection of local aesthetic (ropivicaine) into the transversus abdominis plane in the abdominal wall. This injection takes place after induction of anaesthesia, but before the commencement of surgery. TAP blocks have been proposed as a potential safer alternative to epidural anaesthesia. The blocks have been extensively used in the Hunter New England system over the last 18 months. As yet there is no clear evidence for there efficacy, hence the need for this trial.

This trial would establish the efficacy of this practice. If the technique proves effective it could be widely used and provide a simpler method of managing post operative pain.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
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

入选标准

  • All patients aged 18 and over undergoing elective open or laparoscopic colorectal surgery performed by the participating surgeons within the study period will be considered for the trial.

排除标准

  • History of adverse reaction to Ropivicaine or similar drug.
  • Inability or refusal to give consent
  • Coagulopathic
  • Severe renal impairment
  • Aged <18 years

结局指标

主要结局

mg/kg of morphine equivalent used by patients post operatively.

时间窗: From operation until discharge.

次要结局

  • Lung Function (spirometry), including FVC, FEV1 and PEFR(24, 48 and 72 hours postoperatively)
  • Visual Analogue Scale for pain at rest, deep breathing and coughing.(24, 48 and 72 hours postoperatively)

研究者

发起方
Hunter Colorectal Research
申办方类型
Other

研究点 (8)

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