Preemptive Analgesia in Total Knee Arthroplasty: Comparing the Effects of Single Dose Combined Celecoxib With Pregabaline and Repetition Dose Combined Celecoxib With Pregabaline (Double Blind Controlled Clinical Trial)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- Total Morphine Consumption
研究概览
简要总结
Acute Pain is the most common early complication after total knee arthroplasty that caused delayed mobilization, demands of morphine, and higher operative cost. There were many researches that had been done in analgesia method to find the most effective analgesia, lowest side effect, and easy to apply. Preemptive analgesia of combined celecoxib and pregabalin were reported to give a promising outcome.
In a randomized, double blind controlled clinical trial, 30 subjects underwent surgery for total knee arthroplasty using 15-20mg bupivacaine 5% epidural anesthesia. All subjects were divided into three groups. First group was given celecoxib 400mg and pregabaline 150mg 1 hour before operation, second group was given celecoxib 200mg and pregabaline 75mg twice daily started from 3 days before operation, and the last group was given placebo. The outcome was measured with VAS, knee ROM, and post-operative mobilization
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 55 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •55-80 years old patients who come to orthopaedic polyclinic
- •underwent TKA procedure
- •have osteoarthritis
- •consumed pain killer and anti inflamatory drugs routinely
排除标准
- •psychiatric disorder
- •have history of renal disease
- •histroy of chronic neurophatic
- •have genu arthritis that caused by rheumatid arthritis and infection
- •diabetic and obesity
- •coagulopathy
- •patients with severe pain that needed immediate analgesia regimen
研究组 & 干预措施
Group 1
celecoxib 400mg and pregabaline 150mg 1 hour before operation
干预措施: Celecoxib and Pregabaline (Drug)
Group 2
celecoxib 200mg and pregabaline 75mg twice daily started from 3 days before operation
干预措施: Celecoxib and Pregabaline (Drug)
Group 3
No treatment given
干预措施: Placebo (Other)
结局指标
主要结局
Total Morphine Consumption
时间窗: Third day post-operative
In this study, morphine is given by patient control analgesia (PCA).
次要结局
- Post-operative Pain(every morning [daily], up to 3 days)
- Knee functional outcome(every morning [daily], up to 3 days)
- Mobilization(on the first day, standing on the second day, and walking on the third day)