Pericapsular Nerve Group Block Versus Femoral Nerve Block Study
2026年7月29日 更新者：Taksim Egitim ve Arastirma Hastanesi
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
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.
研究概览
地位
招聘中
条件
详细说明
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.
研究类型
介入性
注册 (估计的)
110
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Celal Kaya, MD
- 电话号码：90 5435176760
- 邮箱：c.kaya47@hotmail.com
学习地点
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-
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Istanbul、土耳其（türkiye）
- 招聘中
- Taksim Training and Research Hospital
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接触：
- Guray Demir, Proffesor
- 电话号码：90 5052113989
- 邮箱：guraydemir@gmail.com
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接触：
- Celal Kaya, MD
- 电话号码：90 5435176760
- 邮箱：c.kaya47@hotmail.com
-
首席研究员：
- Celal Kaya, MD
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Beyoglu
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Istanbul、Beyoglu、土耳其（türkiye）
- 尚未招聘
- Taksim Training and Research Hospital
-
接触：
- celal kaya, MD
- 电话号码：90 5435176760
- 邮箱：celalmadime@gmail.com
-
接触：
- Guray Demir, Proffesor
- 电话号码：90 5052113989
- 邮箱：guraydemir@gmail.com
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：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.
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Ultrasound-guided PENG block performed before spinal anesthesia using 20 mL of 0.25% bupivacaine to provide analgesia for patients undergoing surgery for proximal femur fracture.
Standard spinal anesthesia performed after the assigned peripheral nerve block using intrathecal hyperbaric bupivacaine according to the study protocol.
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有源比较器：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.
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Standard spinal anesthesia performed after the assigned peripheral nerve block using intrathecal hyperbaric bupivacaine according to the study protocol.
Ultrasound-guided femoral nerve block performed before spinal anesthesia using 20 mL of 0.25% bupivacaine to provide analgesia for patients undergoing surgery for proximal femur fracture.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Spinal Anesthesia Convenience Score (SACS)
大体时间：During spinal anesthesia procedure (immediately after patient positioning and before initiation of surgery)
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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.
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During spinal anesthesia procedure (immediately after patient positioning and before initiation of surgery)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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First-Attempt Success of Spinal Anesthesia
大体时间：During the spinal anesthesia procedure.
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The proportion of participants in whom successful intrathecal access is achieved on the first needle insertion attempt.
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During the spinal anesthesia procedure.
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Number of Spinal Needle Insertion Attempts
大体时间：During the spinal anesthesia procedure.
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The total number of spinal needle insertion attempts required to achieve successful spinal anesthesia.
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During the spinal anesthesia procedure.
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Duration of Spinal Anesthesia Procedure
大体时间：During the spinal anesthesia procedure.
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Time from the beginning of patient positioning until completion of spinal anesthesia and return to the supine position, measured in minutes.
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During the spinal anesthesia procedure.
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Anxiety Score
大体时间：Before peripheral nerve block, 30 minutes after block placement, and immediately before surgical incision (after spinal anesthesia).
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Patient anxiety will be assessed using an 11-point Numeric Rating Scale (NRS) ranging from 0 (no anxiety) to 10 (maximum anxiety).
Lower scores indicate less anxiety.
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Before peripheral nerve block, 30 minutes after block placement, and immediately before surgical incision (after spinal anesthesia).
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Patient Satisfaction
大体时间：Postoperative Day 0 (before discharge from the post-anesthesia care unit [PACU])
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Patient satisfaction with the anesthesia process will be assessed using a Numeric Rating Scale ranging from 0 (not satisfied at all) to 10 (completely satisfied).
Higher scores indicate greater satisfaction.
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Postoperative Day 0 (before discharge from the post-anesthesia care unit [PACU])
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Anesthesiologist Satisfaction
大体时间：Immediately after completion of spinal anesthesia.
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The anesthesiologist's satisfaction with procedural conditions will be assessed using a Numeric Rating Scale ranging from 0 (not satisfied at all) to 10 (completely satisfied).
Higher scores indicate greater satisfaction.
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Immediately after completion of spinal anesthesia.
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Perioperative Hemodynamic Parameters
大体时间：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.
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Mean arterial blood pressure will be recorded throughout the perioperative period.
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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.
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Incidence of Hypotension
大体时间：From spinal anesthesia until 30 minutes after surgery completed.
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Hypotension is defined as a mean arterial pressure below 65 mmHg.
The proportion of participants experiencing hypotension will be recorded.
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From spinal anesthesia until 30 minutes after surgery completed.
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Vasopressor Requirement
大体时间：From spinal anesthesia until 30 minutes after surgery completed.
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Total intravenous ephedrine dose administered for the treatment of hypotension, measured in milligrams.
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From spinal anesthesia until 30 minutes after surgery completed.
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Additional Analgesic Medication Requirement
大体时间：During the spinal anesthesia procedure.
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Total doses of intravenous fentanyl (micrograms) administered during positioning for spinal anesthesia.
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During the spinal anesthesia procedure.
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Additional Sedative Medication Requirement
大体时间：During the spinal anesthesia procedure.
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Total doses of intravenous midazolam (milligrams) administered during positioning for spinal anesthesia.
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During the spinal anesthesia procedure.
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Celal Kaya、Taksim Training and Research Hospital
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Giron-Arango L, Peng PWH, Chin KJ, Brull R, Perlas A. Pericapsular Nerve Group (PENG) Block for Hip Fracture. Reg Anesth Pain Med. 2018 Nov;43(8):859-863. doi: 10.1097/AAP.0000000000000847.
- Messina A, La Via L, Milani A, Savi M, Calabro L, Sanfilippo F, Negri K, Castellani G, Cammarota G, Robba C, Morenghi E, Astuto M, Cecconi M. Spinal anesthesia and hypotensive events in hip fracture surgical repair in elderly patients: a meta-analysis. J Anesth Analg Crit Care. 2022 May 8;2(1):19. doi: 10.1186/s44158-022-00047-6.
- Beaudoin FL, Nagdev A, Merchant RC, Becker BM. Ultrasound-guided femoral nerve blocks in elderly patients with hip fractures. Am J Emerg Med. 2010 Jan;28(1):76-81. doi: 10.1016/j.ajem.2008.09.015.
- Erten E, Kara U, Simsek F, Eskin MB, Bilekli AB, Ocal N, Senkal S, Ozdemirkan I. Comparison of pericapsular nerve group block and femoral nerve block in spinal anesthesia position analgesia for proximal femoral fractures in geriatric patients: a randomized clinical trial. Ulus Travma Acil Cerrahi Derg. 2023 Dec;29(12):1368-1375. doi: 10.14744/tjtes.2023.33389.
- Lin DY, Brown B, Morrison C, Kroon HM, Jaarsma RL. Pericapsular nerve group block results in a longer analgesic effect and shorter time to discharge than femoral nerve block in patients after hip fracture surgery: a single-center double-blinded randomized trial. J Int Med Res. 2022 Mar;50(3):3000605221085073. doi: 10.1177/03000605221085073.
- Aygun H, Tulgar S, Yigit Y, Tasdemir A, Kurt C, Genc C, Bilgin S, Senoglu N, Koksal E. Effect of ultrasound-guided pericapsular nerve group (PENG) block on pain during patient positioning for central nervous blockade in hip surgery: a randomized controlled trial. BMC Anesthesiol. 2023 Sep 15;23(1):316. doi: 10.1186/s12871-023-02245-3.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年7月22日
初级完成 (估计的)
2026年12月14日
研究完成 (估计的)
2026年12月22日
研究注册日期
首次提交
2026年7月6日
首先提交符合 QC 标准的
2026年7月16日
首次发布 (实际的)
2026年7月21日
研究记录更新
最后更新发布 (实际的)
2026年7月31日
上次提交的符合 QC 标准的更新
2026年7月29日
最后验证
2026年7月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- E-48670771-514.99-317908988
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
There is no current plan to share individual participant data (IPD).
Future data sharing may be considered upon reasonable request and subject to approval by the sponsor, institutional policies, and applicable ethical and legal requirements.
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研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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