Quadriblock Versus "IPACK + Femoral Triangle Block + Obturator Nerve Block" in Total Knee Arthroplasty: a Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Postoperative analgesia, defined by the morphine consumption in the first 48 hours post-surgery.
研究概览
简要总结
Total knee arthroplasty (TKA) is one of the most common orthopedic surgical procedure and is associated with severe pain in the immediate postoperative period, thus limiting early recovery.
Postoperative pain management requires multimodal analgesia, combining drugs and injection of a local anesthetic (LA). For optimal pain management, several peripheral nerve blocks should be associated. Thus, a recent study shows that the combination of IPACK, femoral triangle and obturator nerve blocks (ITO blocks) provides an effective pain control after TKA.
The hypothesis of this study is that a quadruple nerve block combining femoral, sciatic, obturator and lateral femoral cutaneous nerve blocks (quadri-block) could improve analgesia after TKA.
The main objective of this monocenter, prospective, randomized, open-label, controlled trial is to assess the effect of quadri-block on morphine consumption after TKA compared to ITO blocks.
详细描述
In the pre-anaesthesia room, after the implementation of classical monitoring with an oxygen mask and a peripheral venous catheter, all patients will receive an antibioprophylaxis according to SFAR (French Society of Anesthesia & Intensive Care Medecine) recommendations and injection of 10 mg of IV dexamethasone.
The patients will be then randomized in 2 groups:
- ITO group (usual technique): IPACK combined to femoral triangle and obturator nerve blocks
- Quadriblock group (experimental technique): femoral, sciatic, obturator and lateral femoral cutaneous nerve blocks.
An experienced anesthetist will perform ultrasound-guided blocks 30 minutes before surgery with ropivacaine 0.3%, total volume of 70 ml.
In the operating room, general anesthesia will be induced by intravenous ketamine (0.4 mg/kg) and propofol (3 mg/kg). Anesthesia will be maintained with propofol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Care Provider, 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
- •18 years and older,
- •Primary total knee arthroplasty
- •Consent for participation,
- •Affiliation to a social security system
排除标准
- •Preoperative morphine use
- •Chronic pain syndrome
- •Contraindication to any drugs used in the protocol (paracetamol, ketoprofen, oxynorm, propofol, ketamine, ropivacaine)
- •Valgus > 9°
- •Pregnant or breastfeeding women
- •Patients under protection of the adults (guardianship, curators or safeguard of justice)
结局指标
主要结局
Postoperative analgesia, defined by the morphine consumption in the first 48 hours post-surgery.
时间窗: 48 hours
Total amount of oxynorm (mg) administered during the first 48 hours post-surgery.
次要结局
- Postoperative pain: Verbal Rating Scale (VRS)(48 hours)
- Oxynorm consumption in the first 24 hours post-surgery(24 hours)
- Ability to walk(48 hours)
- Foot elevator muscle mobilization(48 hours)
- Side effects of opioids(48 hours)
- Quadricep mobilization(48 hours)