Pericapsular Nerve Group (PENG) Associated with Lateral Femoral Cutaneous Nerve (LFCN) Block Versus FIC Block for Total Hip Replacement Surgery: a Double Blind Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- MRC at 6h
研究概览
简要总结
Optimal pain control with limited muscle weakness is paramount for a swift initiation of physical therapy and ambulation. Fascia iliaca compartment block (FIC) has been recommended since it offers the best pain control with low risk of motor block. Pericapsular nerve group block (PENG) with lateral femoral cutaneous block (LFCN) has been proposed as an effective alternative to FIB that offers similar pain control with a considerably lower risk of motor block. The aim of this study is to compare the afore mentioned blocks and determine which one yielded the least degree of quadriceps femoris muscle weakness and the better pain control (the lowest NRS score with least need for opioids).
详细描述
This single-center, double blinded RCT investigation will be conducted at ASST Nord Milano - Bassini hospital. The study was approved by the ethics committee "Comitato Etico Territoriale Lombardia 3".
Each patient undergoing elective total hip replacement surgery with anterior approach will be subjected (unless contraindicated) to subarachnoid neuraxial anesthesia and immediately afterwards to a peripheral analgesic block: the FIC block or the association of PENG and FCLN block. The choice of block type will be randomized.
At the end of the procedure, a clinician unaware of the anesthetic technique used will assess the degree of residual motor block. Simultaneously, he will assess pain control in terms of NRS (Numerical Rating Scale) and the need for opioid use.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The anesthetist in the operating room will be the only one who knows what treatment has been administered
Participant: the patient will not know the type of block he will be subjected to, because of he will already be subjected to neuraxial anesthesia.
Outcomes Assessor: a clinician external to the practice will evaluate the degree of residual paralysis after anesthesia and pain control Investigator: the statistician will not know which anesthetic technique was administered to which group
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
- •elective total hip replacement surgery for non-traumatic hip disease,
- •THA (total hip arthroplasty) with lateral approach
- •age >18 years,
- •signed consent form for spinal anesthesia and peripheral nerve block provided by the patient or legal guardian if appointed
排除标准
- •Non elective THA
- •Lack of consent to the procedure
- •Contraindications to performing neuraxial anesthesia (i.e. Signs suggestive of puncture site infection, INR > 1.5, aPTT > 1.5, PLT < 40.000)
- •Documented or suspected allergy to local anesthetics
结局指标
主要结局
MRC at 6h
时间窗: six hours after performing the regional anesthesia technique
evaluation of the degree of weakness or residual paresis of the quadriceps femoris muscle on the operative side using 'the Oxford Scale' (aka Medical Research Council Manual Muscle Testing scale or MRC scale) The MRC scale is a 0-5 scale, with zero meaning "no contraction " and five meaning "Full range of motion against gravity with full resistance".
MRC at 48h
时间窗: 48 hours after performing the regional anesthesia technique
evaluation of the degree of weakness or residual paresis of the quadriceps femoris muscle on the operative side using 'the Oxford Scale' (aka Medical Research Council Manual Muscle Testing scale or MRC scale) The MRC scale is a 0-5 scale, with zero meaning "no contraction " and five meaning "Full range of motion against gravity with full resistance".
MRC at 24h
时间窗: 24 hours after performing the regional anesthesia technique
evaluation of the degree of weakness or residual paresis of the quadriceps femoris muscle on the operative side using 'the Oxford Scale' (aka Medical Research Council Manual Muscle Testing scale or MRC scale) The MRC scale is a 0-5 scale, with zero meaning "no contraction " and five meaning "Full range of motion against gravity with full resistance".
次要结局
- MME of PRN opioid total doses(From date of surgery until up to 72 hours after)
- time to first PRN opioid request(From date of surgery until up to 72 hours after)
- time to first postoperative ambulation(From date of surgery until up to 72 hours after)
- Pain control at 6h(six hours after performing the regional anesthesia technique)
- Pain control at 24h(24 hours after performing the regional anesthesia technique)
- Pain control at 48h(48 hours after performing the regional anesthesia technique)
- need for PRN opioid(From date of surgery until up to 72 hours after)
研究者
Francesco Vetrone, MD
Principal Investigator
Ospedale Edoardo Bassini