Lateral Femoral Cutaneous Nerve (LFCN) Block or Wound Infiltration (WI) Combined With Pericapsular Nerve Group (PENG) Block for Analgesia in Elective Anterior Approach Total Hip Arthroplasty: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- Pain at rest control at 6h
研究概览
简要总结
This prospective, randomized controlled trial aims to compare two multimodal regional anesthesia strategies for postoperative analgesia in elective total hip arthroplasty (THA) performed via anterior approach. Patients will be randomized to receive either a Pericapsular Nerve Group (PENG) block combined with a Lateral Femoral Cutaneous Nerve (LFCN) block, or a PENG block combined with wound infiltration (WI).
The primary outcome is postoperative pain intensity at rest, measured by Numerical Rating Scale (NRS) at 6 hours after surgery. Secondary outcomes include dynamic pain scores at 6, 24, and 48 hours, total opioid consumption, time to first rescue analgesia, quadriceps strength, hip flexion angle, length of stay, and adverse events.
All procedures are routinely used in clinical practice and carry minimal additional risk. Safety will be continuously monitored by the Principal Investigator and the study team according to an internal Safety Monitoring Plan.
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
- •Age > 18 years
- •Elective total hip arthroplasty
- •Spinal (subarachnoid) anesthesia
- •Written informed consent provided by the patient or by the legal guardian, if appointed
排除标准
- •INR > 1.5
- •aPTT > 1.5
- •Platelet count < 75,000/mm³
- •Signs suggestive of infection at the puncture site
- •Absence of informed consent to the procedure
- •Documented or suspected allergy to local anesthetics
结局指标
主要结局
Pain at rest control at 6h
时间窗: six hours after performing the regional anesthesia technique
pain assessment with Numeric Rating Scale (NRS): a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"
次要结局
- Pain at rest control at 24h(24 hours after performing the regional anesthesia technique)
- Pain at rest control at 48h(48 hours after performing the regional anesthesia technique)
- Pain on movement control at 6h(six hours after performing the regional anesthesia technique)
- Pain on movement control at 24h(24 hours after performing the regional anesthesia technique)
- Pain on movement control at 48h(48 hours after performing the regional anesthesia technique)
- the degree of hip flexion at 24h(24 hours after performing the regional anesthesia technique)
- the degree of hip flexion at 48h(48 hours after performing the regional anesthesia technique)
- MRC at 6h(six hours after performing the regional anesthesia technique)
- MRC at 24h(24 hours after performing the regional anesthesia technique)
- MRC at 48h(48 hours after performing the regional anesthesia technique)
- time to first PRN opioid request(Time Frame: From date of surgery until up to 48 hours after)
- MME of PRN opioid total doses(From date of surgery until up to 48 hours after)
- Complication(From date of surgery until up to 48 hours after)
- the degree of hip flexion at 6h(six hours after performing the regional anesthesia technique)
- Length of Hospital Stay (LOS)(From date of surgery until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 10 months)
研究者
Matteo Coccolo
Medical Doctor, Principal Investigator
Ospedale Edoardo Bassini