Ultrasound Guided Lateral Femoral Cutaneous Block (LFCNB) And Femoral Nerve Block (FNB) For Postoperative Pain Control After Hip Surgery
试验速览
- 阶段
- 不适用
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Use of opioids
研究概览
简要总结
Evaluation of the combination of lateral femoral cutaneous nerve "single shot" and femoral nerve "single shot" block as effective and safe alternative postoperative analgesic technique after hip replacement surgery.
详细描述
Clinical evaluation via a prospective, double-blinded, randomized clinical trial, whether ultrasound-guided single femoral block and lateral femoral cutaneous nerve blocks with 20 en 10 cc bupivacaine 0.25% respectively vs. the only ultrasound-guided single femoral block with 20 cc bupivacaine 0.25%, given just prior to elective hip surgery procedure, is effective in reducing acute postoperative pain (VAS scores) and postoperative opiate consumption.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary hip arthroplasty with posterolateral approach.
排除标准
- •Known allergy to levobupivacaine and / or piritramide
- •Known neurological disorders or peripheral neuropathies
- •Existing drug or alcohol abuse
- •Chronic use of pain medication (> started 3 months ago) not related to the hip suffering
- •Coagulopathy (international normalized ratio) > 1.4
- •Thrombocytopenia <70,000 platelets,
- •Pregnancy
- •Local infection hip
- •Hepatic and / or renal impairment
- •BMI> 45.
研究组 & 干预措施
Group 1
Group 1 consented subjects who will receive for their hip surgery procedures general anesthesia (sevoflurane) with single shot femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 cc of 0.9% saline solution for the femoral block and 10 cc of 0.9% saline solution for lateral femoral cutaneous block, for a total of 30 ml saline solution 0.9%.
干预措施: LFCNB (Procedure)
Group 1
Group 1 consented subjects who will receive for their hip surgery procedures general anesthesia (sevoflurane) with single shot femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 cc of 0.9% saline solution for the femoral block and 10 cc of 0.9% saline solution for lateral femoral cutaneous block, for a total of 30 ml saline solution 0.9%.
干预措施: FNB (Procedure)
Group 2
Group 2 consented subjects who will receive for their hip surgery procedures general anesthesia (sevoflurane) with single shot femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 cc of 0.25% bupivacaine solution for the femoral block and 10 cc of 0.9% saline solution for lateral femoral cutaneous block, for a total of 20 cc 0.25% bupivacaine solution en 10 cc saline solution 0.9%.
干预措施: LFCNB (Procedure)
Group 2
Group 2 consented subjects who will receive for their hip surgery procedures general anesthesia (sevoflurane) with single shot femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 cc of 0.25% bupivacaine solution for the femoral block and 10 cc of 0.9% saline solution for lateral femoral cutaneous block, for a total of 20 cc 0.25% bupivacaine solution en 10 cc saline solution 0.9%.
干预措施: FNB (Procedure)
Group 3
Group 3 consented subjects who will receive for their hip surgery procedures general anesthesia (sevoflurane) with single shot femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 cc of 0.25% bupivacaine solution for the femoral block and 10 cc of 0.25% bupivacaine solution for lateral femoral cutaneous block, for a total of 30 cc of 0.25% bupivacaine solution.
干预措施: LFCNB (Procedure)
Group 3
Group 3 consented subjects who will receive for their hip surgery procedures general anesthesia (sevoflurane) with single shot femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 cc of 0.25% bupivacaine solution for the femoral block and 10 cc of 0.25% bupivacaine solution for lateral femoral cutaneous block, for a total of 30 cc of 0.25% bupivacaine solution.
干预措施: FNB (Procedure)
结局指标
主要结局
Use of opioids
时间窗: 48 hours
The primary outcome measure will be a consumption of opioids through the Intravenous Patient Controlled Analgesia pump. Those amounts will be measured en documented at the fixed intervals during the first 48 hours post-procedure.
次要结局
- Visual analog scale (VAS) scores (0-10)(48 hours)
研究者
Ethisch Comité UZ Antwerpen
Ethische Comité UZ Antwerpen
University Hospital, Antwerp