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临床试验/NCT01608035
NCT01608035已完成早期 1 期

Ultrasound Guided Sciatic Perineural Catheter vs Surgically Placed Sciatic Stump Catheter for Below Knee Amputations: Is There A Difference in Patient Outcomes

University of British Columbia2 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2012年9月最近更新:
适应症

试验速览

阶段
早期 1 期
状态
已完成
入组人数
29
试验地点
2
主要终点
Opioid consumption

研究概览

简要总结

The goal of this study is to determine if pre-operative placement of the continuous peripheral nerve block by an anesthesiologist using ultrasound technology is more effective than a continuous peripheral nerve block placed during the surgery by a surgeon for patients undergoing a limb amputation

详细描述

We wish to determine the most effective site for the continuous infusion of local anesthetic for patients undergoing amputation of a limb. The information we obtain from this study will help to decide the most effective manner to provide pain relief for patients in the future. The primary outcome of interest is post-operative pain relief as measured by the amount of pain-relieving medications (opioids) required by patients prior to discharge home. The secondary outcomes of interest will be pain-relieving medications (opioid) requirements during the operation, length of stay in the hospital, time required for mobility, and patient satisfaction- measured by a survey given while in hospital and 3 months later.

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
None

入排标准

年龄范围
16 Years 至 90 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • undergoing a below knee amputation
  • 16 years of age or older
  • regional anesthetic will be used as part of the surgery

排除标准

  • allergic to local anesthetic or ultrasound jelly
  • a contraindication to having a peripheral nerve block catheter

结局指标

主要结局

Opioid consumption

时间窗: Post-op day 0-7

MAR records will be used to calculate opioid consumption

次要结局

  • pain score(Post-op day 0-7 and at 3months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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