Pericapsular Nerve Group Block Versus Femoral Nerve Block Study

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура Ultrasound-Guided Pericapsular Nerve Group (PENG) Block
  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.
• Процедура Ultrasound-Guided Femoral Nerve Block
  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.
• Процедура Spinal Anesthesia (bupivacaine)
  Standard spinal anesthesia performed after the assigned peripheral nerve block using intrathecal hyperbaric bupivacaine according to the study protocol.

Первичные конечные точки

• Spinal Anesthesia Convenience Score (SACS) [Срок оценки: During spinal anesthesia procedure (immediately after patient positioning and before initiation of surgery)]

Вторичные конечные точки (11)

• First-Attempt Success of Spinal Anesthesia [Срок оценки: During the spinal anesthesia procedure.]
• Number of Spinal Needle Insertion Attempts [Срок оценки: During the spinal anesthesia procedure.]
• Duration of Spinal Anesthesia Procedure [Срок оценки: During the spinal anesthesia procedure.]
• Anxiety Score [Срок оценки: Before peripheral nerve block, 30 minutes after block placement, and immediately before surgical incision (after spinal anesthesia).]
• Patient Satisfaction [Срок оценки: Postoperative Day 0 (before discharge from the post-anesthesia care unit [PACU])]
• Anesthesiologist Satisfaction [Срок оценки: Immediately after completion of spinal anesthesia.]
• Perioperative Hemodynamic Parameters [Срок оценки: 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 [Срок оценки: From spinal anesthesia until 30 minutes after surgery completed.]
• Vasopressor Requirement [Срок оценки: From spinal anesthesia until 30 minutes after surgery completed.]
• Additional Analgesic Medication Requirement [Срок оценки: During the spinal anesthesia procedure.]
• Additional Sedative Medication Requirement [Срок оценки: During the spinal anesthesia procedure.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 2 центра

• Taksim Training and Research Hospital — Istanbul
• Taksim Training and Research Hospital — Istanbul

Публикации

• 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. PMID 37386657
• 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. PMID 30063657
• 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. PMID 20006206
• 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. PMID 38073453
• 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. PMID 35291842
• 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. PMID 37715173

Идентификаторы

NCT: NCT07717463 · E-48670771-514.99-317908988

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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