Local Infiltration Analgesia or Intrathecal Morphine in Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Morphine consumption
研究概览
简要总结
The purpose of this study is to determine whether local infiltration analgesia is more effective than intrathecal morphine in reducing postoperative pain in total knee arthroplasty.
详细描述
Postoperative pain is often severe following total knee arthroplasty. Spinal anesthesia is a common method in total knee arthroplasty. Adding morphine to the local anesthetic injected intrathecally prolongs the analgetic effect, but may give the usual opioid side effects. The Local Infiltration Analgesia (LIA) technique has proven effective in reducing postoperative pain in total knee arthroplasty. In the LIA technique a long-acting local anesthetic (ropivacaine), a nonsteroidal anti-inflammatory drug (ketorolac), and epinephrine are infiltrated intraoperatively and via an intraarticular catheter postoperatively.
The aim of this study is to evaluate if spinal anesthesia together with the LIA technique provide better postoperative pain relief and mobilization than spinal anesthesia with addition of morphine to the local anesthetic intrathecally. Primary end-point is morphine consumption the first 48 postoperative hours. Secondary end-points are pain intensity, knee function, time to home readiness, hospital stay, side effects and patient satisfaction. Patients are followed up to 3 months after surgery.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for total knee arthroplasty under spinal anesthesia.
- •Aged 40-85 yrs.
- •ASA physical status I-III and mobility indicating normal postoperative mobilization.
排除标准
- •Known allergy or intolerance to one of the study drugs.
- •Serious liver-, heart- or renal decease.
- •Rheumatoid arthritis.
- •Chronic pain or bleeding disorder.
研究组 & 干预措施
Group LIA
Local Infiltration Analgesia
干预措施: ropivacaine, ketorolac and epinephrine (Drug)
Group M
Intrathecal morphine
干预措施: morphine (Drug)
结局指标
主要结局
Morphine consumption
时间窗: The first 48 postoperative hours
次要结局
- Pain intensity(0-3 months)
- Knee function(0-3 months)
- Time to home readiness(0-2 weeks)
- Hospital stay(0-2 weeks)
- Side effects(0-3 months)
- Patient satisfaction(0-3 months)