Ultrasound-guided Continuous Femoral Nerve Block: The Influence of Catheter Orifice Configuration (Six-hole Versus End-hole) on Post-operative Analgesia After Total Knee Arthroplasty. A Randomized Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- total LA consumption at 24h
研究概览
简要总结
Multiorifice catheters have been shown to provide superior analgesia and significantly reduce local anesthetic consumption compared with end-hole catheters in epidural studies. This prospective, blinded, randomized study tested the hypothesis that, in continuous femoral nerve block (CFNB) under ultrasound guidance, multiorifice catheter would reduce local anesthetic consumption at 24h compared with end-hole catheter.
详细描述
Eighty adult patients (aged ≥18 years) scheduled to undergo primary total knee arthroplasty under a combination of continuous femoral nerve block (CFNB), sciatic nerve block and general anesthesia were randomized to CFNB using either a 3-pair micro-hole (Contiplex, BRAUN®, 20G - 400 mm) or an end-hole (Silverstim VYGON®, 20G - 500 mm) catheter. Once the femoral catheter was sited, a bolus of 20 mL lidocaine 1% was injected. An electronic pump then delivered an automated 5 mL bolus of ropivacaine 0.2% hourly, with 10 mL self-administered patient controlled analgesia boluses.
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)
盲法说明
All investigators, patients, and other clinical staff were blinded to the treatment group. The investigator in charge of the patient was unaware of patient allocation. He did not perform the block or open the sealed and opaque envelope, but followed the patient in the ward. An opaque skin dressing was used in order to blind the type of catheter used. End-hole catheter Vygon is white and stiff whereas six-hole catheter contiplex is yellow and flexible.
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
- •every patient accepting a conitnuous femoral nerve catheter
排除标准
- •pregnancy,
- •any contraindication to peripheral nerve blockade,
- •pre-existing peripheral nerve neuropathy,
- •allergy to LA (study medications),
- •ASA score ≥4,
- •neurologic or neuromuscular disease,
- •psychiatric disease,
- •renal failure,
- •hepatic failure,
- •chronic opioid therapy,
- •NSAID contraindication,
- •inability to use a patient controlled analgesia (PCA) device, g
- •enu valgum,
- •infection at the injection site or
- •withdrawal of consent.
研究组 & 干预措施
six-hole group
lidocaine and ropivacaine injection through catheters
干预措施: lidocaine and ropivacaine injection through catheters (Combination Product)
end-hole group
lidocaine and ropivacaine injection through catheters
干预措施: lidocaine and ropivacaine injection through catheters (Combination Product)
结局指标
主要结局
total LA consumption at 24h
时间窗: 24h after connecting PCA to the femoral nerve catheter
total ropivacaine consumption at 24h in mL
次要结局
- total LA consumption at 48h(48h after connecting PCA to the femoral nerve catheter)
- number of boluses of ropivacaine at 24h(24h after connecting PCA to the femoral nerve catheter)
- number of boluses of ropivacaine at 48 h(48h after connecting PCA to the femoral nerve catheter)
- quadriceps strength before surgery and 24h and 48h after surgery(quadriceps strenght before performing femoral nerve block and 24 and 48h after performing the block)
- morphine requirements at 24h and 48h(morphine consumption at 24h and 48h after completion of surgery)
研究者
FOURNIER ROXANE
MD
University Hospital, Geneva