Postoperative Analgesic Efficacy of Local Infiltration Analgesia Versus Adductor Canal Block After Anterior Cruciate Ligament Reconstruction: A Randomised Controlled Double-blinded Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Total morphine consumption (mg)
研究概览
简要总结
Early rehabilitation after anterior cruciate ligament reconstruction is of paramount importance and requires optimal pain control based on a multimodal concept, including injection of local anaesthetics. Regarding this latter, different options have emerged recently such as the adductor canal block, performed before the surgery by the anaesthesiologist or the infiltration of the articulation performed by the surgeon at the of the intervention. No trial has compared these two approaches. As practice of medicine should be based on evidence, we decided to undertake this randomised controlled trial where we compared the adductor canal block with the local infiltration analgesia technique in terms of pain and functional outcomes
详细描述
Patients scheduled to undergo anterior cruciate ligament reconstruction under general anaesthesia will be randomly allocated to two groups: local infiltration analgesia or adductor canal block.
The local infiltration analgesia will be performed by the surgeon at the end of surgery with 20 mLs of ropivacaine 0.5%. The adductor canal block will be performed by the anaesthesiologist under ultrasound guidance after the surgery, before awaking the patient, using the same solution (20 mLs ropivacaine 0.5%)
Postoperative analgesia will include intravenous patient-controlled analgesia of morphine (settings 1 mg/ml, 2 ml/10 minutes, 40 mg/4 hours), ibuprofen (3x400 mg) and acetaminophen (4x1000 mg).
A research assistant and a physiotherapist, both blinded to the group allocation, will collect pain and rehabilitation data, respectively.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients from 18 to 50 years old scheduled to undergo anterior cruciate ligament reconstruction
排除标准
- •peripheral neuropathy
- •pre-existing femoral neuropathy
- •diabetes mellitus
- •alcoholism
- •drug addiction
- •cancer with chemotherapy
- •chronic pain state
研究组 & 干预措施
Local infiltration analgesia
Infiltration of the knee by the surgeon with local anaesthetics under general anaesthesia.
干预措施: Ropivacaine 0.5% 20 mLs (Drug)
Adductor canal block
Injection of local anaesthetics under ultrasound guidance in the adductor canal by the anaesthesiologist after the surgery, before awaking the patient.
干预措施: Ropivacaine 0.5% 20 mLs (Drug)
结局指标
主要结局
Total morphine consumption (mg)
时间窗: 24 h postoperatively
次要结局
- Pruritus (yes/no)(72 h postoperatively)
- Active flexion(72 h postoperatively)
- Total morphine consumption (mg)(72 h postoperatively)
- Pain scores (numeric rating scale, 0-10) at rest and on movement(72 h postoperatively)
- Postoperative nausea and vomiting (yes/no)(72 h postoperatively)
- Distance walked (meters)(72 h postoperatively)
- Quadriceps muscle strength (numeric scale, 1-5)(72 h postoperatively)
- Anterior Cruciate Ligament - Return to Sport after Injury scale(4 months postoperatively)
- Anterior cruciate ligament -Return to Sport after Injury scale(8 months postoperatively)
- International Knee Documentation Committee score(8 months postoperatively)
研究者
Eric Albrecht
Program Director, Regional Anaesthesia
Centre Hospitalier Universitaire Vaudois