A Randomized, Double-Blinded, Controlled Trial Comparing the Analgesic Efficacy and Motor-Sparing Properties of the Pericapsular Nerve Group (PENG) Block, Suprainguinal Fascia Iliaca Compartment Block (S-FICB), and Lumbar Erector Spinae Plane Block (L-ESPB) in Patients Undergoing Hip Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 93
- 试验地点
- 1
- 主要终点
- Total Opioid Consumption in the First 48 Hours After Surgery
研究概览
简要总结
This randomized, double-blinded, controlled clinical trial compares three motor-sparing regional anesthesia techniques used for postoperative analgesia in patients undergoing hip arthroplasty: the Pericapsular Nerve Group (PENG) block, the suprainguinal Fascia Iliaca Compartment Block (S-FICB), and the Lumbar Erector Spinae Plane Block (L-ESPB). Although all three techniques are widely used in modern hip surgery, their relative analgesic efficacy, opioid-sparing potential, and impact on early functional recovery have not been directly compared in a single study.
The primary objective is to determine which block provides the most effective postoperative analgesia while preserving motor function and facilitating early mobilization. Secondary objectives include comparisons of opioid consumption, pain scores at rest and during movement, time to first rescue analgesia, block-related adverse events, quadriceps strength, incidence of postoperative nausea and vomiting, and early functional outcomes.
This study aims to identify the optimal motor-sparing regional anesthesia strategy for older adults undergoing hip arthroplasty.
详细描述
Regional anesthesia plays a key role in modern multimodal analgesia for hip arthroplasty, particularly in older adults who are vulnerable to opioid-related adverse effects and postoperative functional decline. Several motor-sparing nerve block techniques have been developed to improve postoperative pain control while maintaining quadriceps strength and enabling early mobilization. Among them, the Pericapsular Nerve Group (PENG) block, the suprainguinal Fascia Iliaca Compartment Block (S-FICB), and the Lumbar Erector Spinae Plane Block (L-ESPB) are widely used in clinical practice. However, no randomized clinical trial has directly compared these three approaches within a single study population.
The PENG block targets the articular branches of the femoral, obturator, and accessory obturator nerves, providing selective analgesia of the anterior hip capsule with minimal motor involvement. The suprainguinal FICB delivers a higher spread of local anesthetic over the femoral nerve, lateral femoral cutaneous nerve, and variable portions of the obturator nerve, offering broader sensory coverage but with a higher likelihood of quadriceps weakness. The lumbar ESPB is a posterior fascial plane block that may achieve indirect spread toward the lumbar plexus, potentially providing balanced anterior and posterior capsular analgesia while preserving motor function.
This randomized, double-blinded, three-arm controlled trial aims to compare the analgesic effectiveness, opioid-sparing properties, and motor-sparing characteristics of PENG, S-FICB, and L-ESPB in patients undergoing hip arthroplasty. All participants will receive standardized spinal anesthesia and multimodal postoperative analgesia. The study's primary endpoint is the time to first rescue opioid administration. Secondary outcomes include total postoperative opioid consumption, pain scores at rest and during movement, quadriceps muscle strength, block performance time, incidence of postoperative nausea and vomiting, early mobilization parameters, and block-related adverse events.
The results of this trial are expected to clarify the relative benefits and limitations of the three most commonly used motor-sparing regional anesthesia techniques for hip surgery and to guide optimal selection of blocks for enhanced recovery pathways in older adults undergoing hip arthroplasty.
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)
入排标准
- 年龄范围
- 65 Years 至 100 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 65 years or older scheduled to undergo elective hip arthroplasty under spinal anesthesia.
- •Ability to provide written informed consent.
- •Ability to understand and reliably use numerical pain assessment tools (NRS 0-10).
- •ASA physical status II-III.
- •Expected postoperative hospitalization of at least 48 hours to ensure complete data collection.
排除标准
- •Inability to provide informed consent due to cognitive impairment, language barrier, or severe hearing/speech limitations.
- •Coagulopathy or therapeutic anticoagulation not meeting safety criteria for regional anesthesia.
- •Local infection at the planned block site.
- •Allergy, hypersensitivity, or contraindication to ropivacaine, local anesthetics, or study medications.
- •Pre-existing lower-limb neurological deficits (motor or sensory) affecting outcome assessments.
- •Severe spinal deformity or anatomical limitations preventing safe performance of regional blocks.
- •Chronic opioid use (defined as >30 mg oral morphine equivalents daily for more than 2 weeks).
- •Severe renal failure (eGFR <30 mL/min/1.73m²) or severe hepatic impairment.
- •Uncontrolled diabetes mellitus (fasting glucose >300 mg/dL or HbA1c >10%).
- •History of local anesthetic systemic toxicity (LAST).
- •Participation in another interventional clinical trial within the past 30 days.
- •Any condition deemed by investigators to interfere with protocol adherence, safety monitoring, or outcome reliability.
研究组 & 干预措施
PENG block
Participants in this arm will receive a Pericapsular Nerve Group (PENG) block performed under ultrasound guidance. The block will be administered with 20 mL of 0.2% ropivacaine injected lateral to the iliopsoas tendon at the level of the anterior inferior iliac spine and iliopubic eminence. No additional peripheral nerve blocks will be performed. All participants will receive standardized spinal anesthesia and multimodal postoperative analgesia.
干预措施: Pericapsular Nerve Group (PENG) Block (Procedure)
Suprainguinal FICB
Participants will receive a suprainguinal Fascia Iliaca Compartment Block (S-FICB) performed under ultrasound guidance. A total of 40 mL of 0.2% ropivacaine will be injected in the suprainguinal fascia iliaca plane to achieve spread toward the femoral nerve, lateral femoral cutaneous nerve, and obturator nerve. All participants will receive standardized spinal anesthesia and multimodal postoperative analgesia.
干预措施: Suprainguinal Fascia Iliaca Compartment Block (S-FICB) (Procedure)
Lumbar ESPB
Participants will receive a lumbar Erector Spinae Plane Block (L-ESPB) performed under ultrasound guidance at the L4 transverse process level. A total of 20 mL of 0.2% ropivacaine will be injected deep to the erector spinae muscle and superficial to the transverse process. No sacral ESPB will be added. All participants will receive standardized spinal anesthesia and multimodal postoperative analgesia.
干预措施: Lumbar Erector Spinae Plane Block (L-ESPB) (Procedure)
结局指标
主要结局
Total Opioid Consumption in the First 48 Hours After Surgery
时间窗: 0-48 hours postoperatively
Total cumulative opioid consumption recorded in the first 48 postoperative hours, converted to morphine milligram equivalents (MME). Includes all opioid medications administered as part of postoperative analgesia, both scheduled and rescue doses. Data will be extracted from electronic medication records and converted using standard MME conversion factors.
次要结局
- Adverse Events Related to Regional Anesthesia(Up to 48 hours postoperatively)
- Time to First Rescue Opioid Administration(0-48 hours postoperatively)
- Numerical Rating Scale (NRS) Pain Scores at Rest(48 hours postoperatively)
- Numerical Rating Scale (NRS) Pain Scores During Movement(48 hours postoperatively)
- Quadriceps Muscle Strength(48 hours postoperatively)
- Incidence of Postoperative Nausea and Vomiting (PONV)(0-24 hours postoperatively)
- Time to First Mobilization(0-48 hours postoperatively)
- Numerical Rating Scale (NRS) Pain Scores at Rest(4 hours postoperatively)
- Numerical Rating Scale (NRS) Pain Scores at Rest(8 hours postoperatively)
- Numerical Rating Scale (NRS) Pain Scores at Rest(12 hours postoperatively)
- Numerical Rating Scale (NRS) Pain Scores at Rest(24 hours postoperatively)
- Numerical Rating Scale (NRS) Pain Scores During Movement(4 hours postoperatively)
- Numerical Rating Scale (NRS) Pain Scores During Movement(8 hours postoperatively)
- Numerical Rating Scale (NRS) Pain Scores During Movement(12 hours postoperatively)
- Numerical Rating Scale (NRS) Pain Scores During Movement(24 hours postoperatively)
- Quadriceps Muscle Strength(4 hours postoperatively)
- Quadriceps Muscle Strength(8 hours postoperatively)
- Quadriceps Muscle Strength(12 hours postoperatively)
- Quadriceps Muscle Strength(24 hours postoperatively)