NCT01364194已完成4 期
Periarticular Injection With Bupivacaine For Post-Operative Pain Control In Total Knee Replacement: A Prospective Randomized Double-Blind Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Post operative pain
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of periarticular injection with 0.25% bupivacaine for controlling pain after total knee replacement to improve the quality of post-operative care.
详细描述
Compare post operative pain control after total knee replacement by periarticular injection with 0.25% bupivacaine compare with 0.9% normal saline.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •primary osteoarthritis patients undergoing total knee replacement at Siriraj Hospital
- •BMI between 20-35
- •having a full understanding of the question in this trial
排除标准
- •allergy to NSAIDs, Acetaminophen, Bupivacaine
- •blood creatinine more than 1.5 mg/dl or creatinine clearance less than 60 mL/min
- •abnormal liver function
- •previous surgery on the knee undergoing total knee replacement
- •patient could not receive spinal anesthesia
研究组 & 干预措施
0.25% Bupivacaine
Active Comparator
Periarticular injection with 20 ml of 0.25% bupivacaine before wound closure.
干预措施: 0.25% Bupivacaine (Drug)
0.9% normal saline
Placebo Comparator
Periarticular injection with 20 ml of 0.9% normal saline before wound closure.
干预措施: 0.9% normal saline (Drug)
结局指标
主要结局
Post operative pain
时间窗: 96 hour post operation
Measure by Visual analog scale scores and morphine consumption
次要结局
- Complication of Morphine consumption(96 hour post operation)
研究者
研究点 (1)
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