NCT04206046进行中（未招募）不适用
The Effect of Regional Anaesthesia and Genetic Factors in the Development of Chronic Pain Following Total Knee Arthroplasty
Sciberras, Stephen M.D.2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2017年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Pain Numerical Rating Scale on physiotherapy
研究概览
简要总结
The study aims to assess the effect of spinal anaesthesia against a general anaesthesia with a femoral block, with respect to the incidence of chronic pain following a total knee replacement.
It will also focus on genetic factors and their influence on chronic pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients able to undergo a total knee arthroplasty
排除标准
- •age more than 75 years
- •known case of chronic pain syndromes
- •arthroplasty not due to osteoarthritis
- •sensitivity to any drugs used in protocol
结局指标
主要结局
Pain Numerical Rating Scale on physiotherapy
时间窗: 24 hours
Pain Numerical Rating Scale, from 0 (no pain) to 10 (severe pain)
WOMAC Score at 3 and at 6 months
时间窗: 6 months
WOMAC score, ranging from 0 to 94
WOMAC Pain Score at 3 and at 6 months
时间窗: 6 months
WOMAC Pain score, ranging from 0 (no pain) to 20 (severe pain on numerous activities)
次要结局
- Incidence of Chronic Post-surgical Pain(6 months)
- Change in WOMAC Pain Score at 3 and at 6 months(6 months)
- Pain Numerical Rating Scale after 6 months(6 months)
- Change in WOMAC Score at 3 and at 6 months(6 months)
- Morphine consumption(24 hours)
研究者
Stephen Sciberras
Lead investigator
Sciberras, Stephen M.D.
研究点 (2)
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