Optimal Pain Control After Prothetic Knee Surgery Either by Selective Tibial Nerve Block Versus Local Infiltration Analgesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Total morphine consumption (mg)
研究概览
简要总结
Patient suffer from moderate posterior knee pain after TKA despite injection of local anesthetic around the femoral or saphenous nerves. Indeed, the posterior part of the knee is innervated by the sciatic nerve. This nerve is not routinely blocked as clinicians fear to produce a motor block of the leg that might impair the postoperative assessment. An analgesic alternative is the infiltration of the knee with local anesthetics performed by the surgeon. Recently a trial(1) demonstrated that a selective tibial nerve block provides an effective analgesia without a motor blockage when compared with a sciatic nerve block. The objective of this randomized controlled double-blinded trial is to assess whether a tibial nerve block is more effective for the postoperative pain than local infiltration analgesia when there are combined with an adductor canal block, without decreasing the functional parameters.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient scheduled for a total knee arthroplasty under spinal block.
- •Patient with a weight above 40kg.
排除标准
- •Patient with ASA IV status.
- •Contraindication to spinal block, or peripheral nerve blocks.
- •Neurological deficit of the lower limb.
- •Patient with renal dysfunction.
- •Patient with chronic pain, opioid consumption or alcohol consumption.
- •Pregnancy.
研究组 & 干预措施
Tibial nerve block
Adductor canal and tibial nerve blocks performed by the anesthetist under ultrasound guidance before spinal block.
干预措施: Ropivacaine 0.5% Injectable Solution (Drug)
Local infiltration analgesia
Adductor canal block by the anesthetist under ultrasound guidance before spinal block. Infiltration of the knee by the surgeon with local anesthetic at the end of the surgery.
干预措施: Ropivacaine 0.2% Injectable Solution (Drug)
结局指标
主要结局
Total morphine consumption (mg)
时间窗: 24 hours postoperatively
次要结局
- Length of stay in hospital(up to 14 days)
- Rate of postoperative nausea and vomiting(2 hours, 24 hours, 48 hours and 72 hours postoperatively)
- Quadriceps muscle strength (numeric scale, 1-5)(24hours, 48hours and 72hours postoperatively)
- Analgesic duration (minutes)(Postoperative day 0)
- Complication of tibial nerve block(up to 1 week)
- Total morphine consumption (mg)(2 hours, 48 hours and 72 hours postoperatively)
- Pain scores (numeric rating scale, 0-10) at rest and on movement(2 hours, 24 hours, 48 hours and 72 hours postoperatively)
- Rate of prurit(2 hours, 24 hours, 48 hours and 72 hours postoperatively)
- Active flexion(24hours, 48hours and 72hours postoperatively)
- Passive flexion(24hours, 48hours and 72hours postoperatively)
- Distance walked (meters)(24hours, 48hours and 72hours postoperatively)
研究者
Eric Albrecht
Program director of regional anaesthesia
Centre Hospitalier Universitaire Vaudois