NCT05017701终止不适用
Feasibility of Bridge for Post-Operative Pain Management in Hip Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Change in Total Opioid Consumption Between Active and Sham Arms.
研究概览
简要总结
The aim of this research study is to gather data regarding the feasibility of the Bridge system for the management of pain following total hip arthroplasty (THA).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- 否
入选标准
- •Subject is 18 years of age or older
- •Subject scheduled for elective primary unilateral total hip arthroplasty (THA)
- •Subject opioid use is less than 60 milligram morphine equivalent for the last 30 days
- •Subject has given written informed consent to participate in the study
排除标准
- •Subjects who are pregnant or breastfeeding
- •Subjects with cardiac pacemakers or other implanted devices (e.g. vagal nerve simulators), hemophilia or psoriasis vulgaris
- •Subjects with a history of active depression, anxiety or catastrophizing
- •Subjects with active alcoholism or drug abuse
- •Subjects with severe chronic pain condition that requires daily preoperative opioid dependence
- •Subjects deemed not suitable for the study at the discretion of the principal investigator
- •Subjects who are concurrently participating in any other research study
结局指标
主要结局
Change in Total Opioid Consumption Between Active and Sham Arms.
时间窗: Day of surgery to Day 5 (120 hours) post-op
The sample size is well below the threshold needed to reliably assess outcomes and perform statistical comparisons. As a result, we have provided the raw data for comparison of opioid consumption between the two groups.
次要结局
- Change in Pain Between Active and Sham Arms as Measured Using the Numeric Rating Scale.(Day of surgery to Day 5 (120 hours) post-op)
- Change in Postoperative Nausea Between Active and Sham Arms as Measured Using a Postoperative Nausea and Vomiting Rating Scale.(Day of surgery to Day 5 (120 hours) post-op)
- Change in Functional Recovery Between Active and Sham Arms Assessed Using the Timed Up and Go (TUG) Assessment Collected on Post-Op Day 30(Day of surgery to post-operative day 30.)
- Change in Functional Recovery Between Active and Sham Arms Assessed Using the 12-Item Short Form Survey (SF-12) Collected on Post-Op Day 30(Day of surgery to post-operative day 30.)
研究者
研究点 (2)
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