Management of Postoperative Pain After Total Hip Arthroplasty
试验速览
- 阶段
- 2 期
- 发起方
- 试验地点
- 1
- 主要终点
- Pain VAS score
研究概览
简要总结
Orthopedic surgery is reportedly among the most painful surgical procedures. Surgical damage following major orthopedic surgery often involves a large, deep incision with considerable tissue dissection and muscle, bone, and vascular exposure. Post-operative pain after such surgery is exacerbated on movement or by reflex spasms of the muscles, which may delay mobilization, reduce satisfaction, prolong hospitalization, and possibly increase medical costs.
We design a prospective randomized study for postoperative pain control following total hip arthroplasty.
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, Outcomes Assessor)
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
- 是
入选标准
- •diagnosed for surgery of osteoarthritis of hip
- •ability to tolerate surgery under general anesthesia.
排除标准
- •refusal or the lack of mental ability to provide informed consent
- •neuropathic pain or sensory disorders in the leg requiring surgery
- •previous surgery of the hip joint
- •coagulation abnormalities
- •severe renal or hepatic impairment
- •chronic opioid users
- •known history of intolerance to the drugs used in the study
研究组 & 干预措施
Experiment
Anesthetics intraarticular injection
干预措施: Bupivacaine (Drug)
Placebo
saline intraarticular injection
干预措施: Placebo (Drug)
结局指标
主要结局
Pain VAS score
时间窗: pre-operaton, immediately post operation, postop 6hrs, postop 12hrs, postop 18hrs, postop 24hrs, post op 48hrs, postop 72hrs
次要结局
- Functional score: WOMAC hip score, SF-36(Pre-operation, immediately post-operation, postop 6 weeks, postop 12 weeks)