Pain Treatment After Total Knee Replacement - Continuous Epidural Versus Intravenous Patient Controlled Analgesia With Morphine
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Visual analog scale (VAS) (rest/movement) during first 24 hours post-operation
研究概览
简要总结
The study purpose is to compare the effectiveness of different methods for post-operative pain treatment after total knee replacement.
详细描述
Total knee replacement (TKR) is known to be one of the most painful surgical procedures. Many treatments have been used post TKR: IV opioids, epidural infusions, peripheral nerve blocks. No one method has been recognised as the best one.
In this study we will compare two well established methods of pain treatment:
- continuous infusion of local anesthetics + opioids into the epidural space,
- patient controlled analgesia with IV Morphine.
The study design is double blind.
Patients will have a combined spinal-epidural anesthesia for the operation and then will be connected to 2 different pumps, one to the epidural catheter and one to the intravenous catheter, for the first 24 hours post-operatively.
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
入排标准
- 年龄范围
- 55 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent
- •Age: 55 to 85 years
- •Osteoarthritis
- •Primary unilateral total knee replacement
- •American Society of Anesthesiologists (ASA) I-III
- •Successful spinal epidural anesthesia for surgery
排除标准
- •Any cause for knee replacement other than osteoarthritis
- •Total knee revision (re-do)
- •Any contraindication for regional anesthesia
- •Abnormal coagulation studies
- •Thrombocytopenia less than 100,000/cc
- •Chronic renal failure (creatinine [cr] < 1.8)
- •Neurological disease involving lower extremities
- •Major surgery during the last 2 weeks pre-operatively
- •Current or past drug or alcohol abuse
- •Allergy to study medications
- •Post-operative bleeding over 2000 cc/24 hours
- •Postdural puncture headache after anesthesia performance
结局指标
主要结局
Visual analog scale (VAS) (rest/movement) during first 24 hours post-operation
Total dose of rescue analgesics during first 24 hours post-operation
次要结局
- Adverse reactions, complications
- VAS (rest/movement) + total dose rescue analgesics after 24 hours post-operation until discharge
- Patient outcome questionnaire
- Physiotherapy performance VAS (rest/walking, passive extension, maximal angle, knee flexion/extension)