Comparison of Preoperative Pericapsular Nerve Group (PENG) Block Versus Femoral Nerve Block for Optimizing Spinal Anaesthesia in Proximal Femur Fracture Surgery: A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 110
- 试验地点
- 3
- 主要终点
- Spinal Anesthesia Convenience Score (SACS)
研究概览
简要总结
Hip fractures are common in older adults and are often associated with severe pain, making it difficult for patients to sit for spinal anesthesia before surgery. Peripheral nerve blocks may improve pain control and facilitate patient positioning, but it remains uncertain whether the Pericapsular Nerve Group (PENG) block provides advantages over the traditional femoral nerve block during the spinal anesthesia procedure.
详细描述
Hip fractures are among the most common injuries in older adults and are associated with substantial morbidity, mortality, and healthcare utilization. Spinal anesthesia is frequently used for surgical repair of proximal femur fractures because of its favorable safety profile in elderly patients. However, severe pain caused by the fracture often makes positioning for spinal anesthesia difficult, resulting in patient discomfort, prolonged procedure time, multiple needle insertion attempts, and increased procedural complexity.
Peripheral nerve blocks are increasingly used before spinal anesthesia to improve analgesia and facilitate patient positioning. The femoral nerve block (FNB) has long been established as an effective regional anesthesia technique for patients with hip fractures. More recently, the ultrasound-guided Pericapsular Nerve Group (PENG) block has been introduced as a motor-sparing technique targeting the articular branches of the femoral, obturator, and accessory obturator nerves that innervate the anterior hip capsule. Previous studies have demonstrated that the PENG block provides effective analgesia during positioning for spinal anesthesia and may offer superior pain relief compared with conventional techniques. However, evidence comparing the effects of PENG block and femoral nerve block on the technical performance of spinal anesthesia and perioperative hemodynamic stability remains limited.
This prospective, randomized controlled trial is designed to compare ultrasound-guided PENG block with ultrasound-guided femoral nerve block in patients undergoing surgery for proximal femur fracture under spinal anesthesia. The study will evaluate whether PENG block improves procedural conditions for spinal anesthesia compared with femoral nerve block while also assessing perioperative analgesia and hemodynamic responses.
The study hypothesis is that preoperative PENG block will provide better procedural conditions for spinal anesthesia than femoral nerve block by improving patient positioning, reducing pain during positioning, facilitating spinal needle placement, decreasing the need for supplemental analgesic or sedative medication, and contributing to greater perioperative hemodynamic stability.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 50 years or older.
- •Diagnosis of proximal femoral fracture.
- •Scheduled to undergo surgical repair under spinal anesthesia.
- •American Society of Anesthesiologists (ASA) physical status I-III.
- •Able to provide written informed consent.
排除标准
- •Refusal to participate or inability to provide informed consent.
- •Coagulopathy or contraindication to spinal anesthesia or peripheral nerve block.
- •Local infection at the planned injection site.
- •Known allergy or hypersensitivity to local anesthetics.
- •Pre-existing neurological disease affecting lower extremity function or sensory assessment.
- •Cognitive impairment preventing reliable study participation or outcome assessment.
- •Previous lumbar spine surgery.
- •Polytrauma.
- •Body mass index (BMI) <18 kg/m² or >40 kg/m².
- •Current anticoagulant therapy that precludes neuraxial anesthesia or peripheral nerve block according to institutional practice.
研究组 & 干预措施
Femoral Nerve Block
Participants will receive a preoperative ultrasound-guided femoral nerve block with 20 mL of 0.25% bupivacaine before spinal anesthesia for proximal femur fracture surgery. Spinal anesthesia will subsequently be performed according to the standardized study protocol.
干预措施: Spinal Anesthesia (bupivacaine) (Procedure)
PENG Block
Participants will receive a preoperative ultrasound-guided Pericapsular Nerve Group (PENG) block with 20 mL of 0.25% bupivacaine before spinal anesthesia for proximal femur fracture surgery. Spinal anesthesia will subsequently be performed according to the standardized study protocol.
干预措施: Ultrasound-Guided Pericapsular Nerve Group (PENG) Block (Procedure)
PENG Block
Participants will receive a preoperative ultrasound-guided Pericapsular Nerve Group (PENG) block with 20 mL of 0.25% bupivacaine before spinal anesthesia for proximal femur fracture surgery. Spinal anesthesia will subsequently be performed according to the standardized study protocol.
干预措施: Spinal Anesthesia (bupivacaine) (Procedure)
Femoral Nerve Block
Participants will receive a preoperative ultrasound-guided femoral nerve block with 20 mL of 0.25% bupivacaine before spinal anesthesia for proximal femur fracture surgery. Spinal anesthesia will subsequently be performed according to the standardized study protocol.
干预措施: Ultrasound-Guided Femoral Nerve Block (Procedure)
结局指标
主要结局
Spinal Anesthesia Convenience Score (SACS)
时间窗: During spinal anesthesia procedure (immediately after patient positioning and before initiation of surgery)
Spinal anesthesia convenience will be assessed using the Spinal Anesthesia Convenience Score (SACS), a composite clinical score evaluating the ease of spinal anesthesia based on anatomical landmark palpation, patient cooperation, sitting position quality, pain during passive hip flexion, and pain while maintaining the sitting position. Total scores range from 0 to 11, with higher scores indicating easier spinal anesthesia conditions.
次要结局
- Anxiety Score(Before peripheral nerve block, 30 minutes after block placement, and immediately before surgical incision (after spinal anesthesia).)
- Patient Satisfaction(Postoperative Day 0 (before discharge from the post-anesthesia care unit [PACU]))
- Anesthesiologist Satisfaction(Immediately after completion of spinal anesthesia.)
- Perioperative Hemodynamic Parameters(Before peripheral nerve block; 1, 5, 10, 15, and 30 minutes after block placement; and 1, 5, 10, 15, and 30 minutes after spinal anesthesia.)
- Incidence of Hypotension(From spinal anesthesia until 30 minutes after surgery completed.)
- Vasopressor Requirement(From spinal anesthesia until 30 minutes after surgery completed.)
- Additional Analgesic Medication Requirement(During the spinal anesthesia procedure.)
- Additional Sedative Medication Requirement(During the spinal anesthesia procedure.)
- First-Attempt Success of Spinal Anesthesia(During the spinal anesthesia procedure.)
- Number of Spinal Needle Insertion Attempts(During the spinal anesthesia procedure.)
- Duration of Spinal Anesthesia Procedure(During the spinal anesthesia procedure.)