跳至主要内容
临床试验/NCT00724074
NCT00724074Unknown不适用

The Use of Continuous Wound Infusion Analgesia in Total Knee Arthroplasty

Capital Health, Canada1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2008年7月29日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
20
试验地点
1
主要终点
Pain, measured by the 11-point numerical pain rating scale

研究概览

简要总结

The main purpose of this study is to determine if there is improvement in pain and other patient outcomes when using a continuous wound analgesia system after total knee replacement, compared to usual methods of pain control. Another purpose is to determine if the system makes it easier for nurses to care for these patients.

详细描述

Continuous local wound infusion analgesia is a relatively new way of managing post-operative pain, whereby a local anesthetic is continuously infused into the surgical area. Some studies and users have reported decreased pain, decreased opioid use, decreased post-operative nausea and vomiting, decreased length of stay, and improved patient and caregiver satisfaction with the use of continuous local wound infusion analgesia, when compared to placebo, or usual care, in arthroplasty and other surgical interventions.

Hypotheses:

Primary:

The On-Q PainBuster (continuous wound infusion analgesia) in TKA will result in improved patient pain control, compared to usual care.

Secondary:

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
18 Years 至 69 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Scheduled for TKA at the Royal Alexandra Hospital
  • Patient of Dr. Arnett
  • Deemed fit for continuous wound infusion (no allergies to Bupivacaine or related medications) by anesthesia
  • Cognitively aware, and provides informed consent
  • Elective (not trauma-related) surgery
  • Able to read, speak and understand English
  • Adult < 70 years of age
  • Intra-operative spinal anaesthesia
  • Reside within metropolitan Edmonton, in a bungalow
  • Have a caregiver at home
  • ASA risk classification of 1 or 2
  • Do not regularly use opioid medication pre-operatively
  • Have preoperative knee range of motion > 90 degrees
  • Body Mass Index < 40
  • No known hepatic or liver insufficiency

排除标准

  • Deemed unfit for continuous wound infusion due to allergies
  • Other exclusion criteria to be determined

结局指标

主要结局

Pain, measured by the 11-point numerical pain rating scale

时间窗: Post-operatively for three days then again at follow-up

次要结局

  • Post-operative nausea and vomiting(Post-operatively for three days)
  • Narcotic medications taken(Post-operatively for three days)
  • Time to first mobilization, first transfer and first 30-M walk(Up to three days post-operatively)
  • Number of adverse events(Three days post-op (observed) then at follow-up (self-report))
  • Length of Stay(Time of surgery to discharge)
  • Satisfaction (patient and caregiver)(Discharge from hospital)

研究者

发起方
Capital Health, Canada
申办方类型
Other

研究点 (1)

Loading locations...

相似试验