Pericapsular Nerve Group Block Versus Femoral Nerve Block Study
29 de julio de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
110
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Celal Kaya, MD
- Número de teléfono: 90 5435176760
- Correo electrónico: c.kaya47@hotmail.com
Ubicaciones de estudio
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Istanbul, Turquía (Türkiye)
- Reclutamiento
- Taksim Training and Research Hospital
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Contacto:
- Guray Demir, Proffesor
- Número de teléfono: 90 5052113989
- Correo electrónico: guraydemir@gmail.com
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Contacto:
- Celal Kaya, MD
- Número de teléfono: 90 5435176760
- Correo electrónico: c.kaya47@hotmail.com
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Investigador principal:
- Celal Kaya, MD
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Beyoglu
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Istanbul, Beyoglu, Turquía (Türkiye)
- Aún no reclutando
- Taksim Training and Research Hospital
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Contacto:
- celal kaya, MD
- Número de teléfono: 90 5435176760
- Correo electrónico: celalmadime@gmail.com
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Contacto:
- Guray Demir, Proffesor
- Número de teléfono: 90 5052113989
- Correo electrónico: guraydemir@gmail.com
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-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: 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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Comparador activo: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Spinal Anesthesia Convenience Score (SACS)
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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First-Attempt Success of Spinal Anesthesia
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Celal Kaya, Taksim Training and Research Hospital
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
22 de julio de 2026
Finalización primaria (Estimado)
14 de diciembre de 2026
Finalización del estudio (Estimado)
22 de diciembre de 2026
Fechas de registro del estudio
Enviado por primera vez
6 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
16 de julio de 2026
Publicado por primera vez (Actual)
21 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
31 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
29 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Heridas y Lesiones
- Lesiones en las piernas
- Fracturas, Hueso
- Fracturas Femorales
- Lesiones de cadera
- Fracturas de cadera
- Químicos orgánicos
- Aniluros
- Amidas
- Compuestos anilina
- Amina
- Anestesia y analgesia
- Sistema digestivo y fenómenos fisiológicos orales
- Anestesia, conducción
- Anestesia
- Odontología
- Fenómenos fisiológicos dentales
- Bupivacaína
- Anestesia, espinal
- Oclusión dental
Otros números de identificación del estudio
- E-48670771-514.99-317908988
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .