跳至主要内容
临床试验/NCT01019005
NCT01019005Unknown不适用

Pain Relief After Forefoot Surgery: Tibial Perineural Catheter vs. Wound Catheter Infusion

Nottingham University Hospitals NHS Trust1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2010年2月最近更新:
适应症

试验速览

阶段
不适用
入组人数
75
试验地点
1
主要终点
Post-operative pain

研究概览

简要总结

The aim to test whether continues local anaesthetic infusion via tibial catheter or wound catheter will improve pain relief following forefoot surgery

In this sequential prospective randomised, controlled clinical trial,75 Patients undergoing forefoot surgery will be randomized into three groups (tibial, wound, control). All groups will receive ankle block ± general anesthetic (standard technique). The tibial group will have a tibial catheter inserted through which local anaesthetic will be infused. The wound group will have a catheter inserted directly into the wound immediately after surgery. The control group will have a sham catheter (covered by a bandage across foot) attached to a pump which will not infuse. Patient maximum pain scores (primary outcome measure), nausea/ vomiting, analgesia use, satisfaction and sleep disturbance will be recorded postoperatively. All groups will be then followed by telephone calls 48 hours. Patients will be instructed to come to the clinic on the 4th postoperative day where the catheter will be removed.

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
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 years or older (ASA I & II)
  • Able to give written consent
  • Patients having elective forefoot surgery with a planned ankle block.
  • Expected postoperative pain to be at least moderate in severity the day following surgery

排除标准

  • Inability to communicate
  • History of alcohol or opioid abuse (also chronic opioid user)
  • Mental or medical conditions which may affect quantifying pain scores (VAS)

结局指标

主要结局

Post-operative pain

时间窗: 2,8,12,24,48 hr

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (1)

Loading locations...

相似试验