Enhanced Recovery After Surgery and Total Knee Replacement: A Prospective, Randomized Study on the Rule of Peripheral Nerve Blocks on Persistent Postoperative Pain Six Months After Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 436
- 试验地点
- 2
- 主要终点
- Persistent post surgical pain
研究概览
简要总结
Patients undergone total knee replacement are randomized to receive a "fast track" regional anesthesia protocol or a "traditional" regional anesthesia continuous infusion by both a femoral and sciatic catheter to assess if this latter technique may reduce persistent postoperative pain six months after surgery
详细描述
Patients undergone to primary total knee replacement with spinal anesthesia are randomized to receive a continuous adductor canal block infusion + an ipack block or a continuous femoral nerve block + a continuous sciatic nerve block just at the end of surgery. Both group will receive a multimodal analgesia with paracetamol, ketorolac, desametasone and morphine as a rescue.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •primary total knee replacement with a written informed consent
排除标准
- •Allergy to local anesthetics or any drugs involve in the study
- •Controindication to regional anesthesia
- •chronic use of opioids
- •BMI > 35 kg m2
结局指标
主要结局
Persistent post surgical pain
时间窗: 0-6-month
Numeric rating score (0-10) over 4 at the follow up 6-month after total knee replacement
次要结局
- acute postoperative pain(0-72 hours)
- Morphine requirement(0-72 hours)
研究者
Gianluca Cappelleri
MD
Policlinico di Monza SpA