Analgesic Efficacy of a Combined Saphenous Nerve Block and IPACK Block Versus Local Infiltration Analgesia After Anterior Cruciate Ligament Reconstruction: a Randomized Controlled Double-blinded Trial.
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
A lot of patient have posterior knee pain after ACL reconstruction despite saphenous nerve block. Recently a new block has been described, know as IPACK block (interspace between the popliteal artery and the capsule of the posterior knee). The objective of this randomized controlled double-blinded trial is to assess whether a combined saphenous nerve block with IPACK block is more effective for the postoperative pain than a local infiltration analgesia.
详细描述
The saphenous nerve and the iPACK will be performed after general anaesthesia induction and before the surgery under ultrasound-guidance.
The local infiltration analgesia will be performed by the surgeon during the 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, 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
- •Statut ASA I-III.
- •Patient scheduled for anterior crutiate ligament reconstruction under general anesthesia.
排除标准
- •Pregnancy.
- •Contraindication to local anesthesia.
- •Patient with chronic pain, opioid consumption or alcohol consumption.
- •Patient with coagulation trouble, hepatic dysfunction or renal dysfunction.
- •Patient with diabetic or femoral neuropathy.
研究组 & 干预措施
Local infiltration analgesia
Periarticular infiltration by surgeon
干预措施: Ropivacaine injection (Drug)
IPACK block
Saphenous nerve block and IPACK block by anesthetist under ultrasound guidance.
干预措施: Ropivacaine injection (Drug)
结局指标
主要结局
Total morphine consumption (mg)
时间窗: 24 hours postoperatively
次要结局
- Pain scores (numeric rating scale, 0-10) at rest and on movement(2hours, 24hours, 48hours and 72hours postoperatively)
- International Knee Documentation Committee score(4 and 8 postoperative months)
- Rate of postoperative nausea and vomiting(2hours, 24hours, 48hours and 72hours postoperatively)
- Rate of antiemetic consumption(2hours, 24hours, 48hours and 72hours postoperatively)
- Rate of pruritus(2hours, 24hours, 48hours and 72hours postoperatively)
- Active flexion(24hours, 48hours and 72hours postoperatively)
- Distance walked (meters)(24 hours, 48hours and 72hours postoperatively)
- Anterior Cruciate Ligament - Return to Sport after Injury survey(4 and 8 postoperative months)
- Total morphine consumption (mg)(2 hours, 48 hours and 72 hours postoperatively)
- Quadriceps muscle strength (numeric scale, 1-5)(24hours, 48hours and 72hours postoperatively)
研究者
Eric Albrecht
Program director of regional anaesthesia
Centre Hospitalier Universitaire Vaudois