Pericapsular Nerve Group Block Versus Femoral Nerve Block Study
29 de julho de 2026 atualizado 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.
Visão geral do estudo
Status
Recrutamento
Condições
Descrição detalhada
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 estudo
Intervencional
Inscrição (Estimado)
110
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Celal Kaya, MD
- Número de telefone: 90 5435176760
- E-mail: c.kaya47@hotmail.com
Locais de estudo
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Istanbul, Turquia (Türkiye)
- Recrutamento
- Taksim Training and Research Hospital
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Contato:
- Guray Demir, Proffesor
- Número de telefone: 90 5052113989
- E-mail: guraydemir@gmail.com
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Contato:
- Celal Kaya, MD
- Número de telefone: 90 5435176760
- E-mail: c.kaya47@hotmail.com
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Investigador principal:
- Celal Kaya, MD
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Beyoglu
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Istanbul, Beyoglu, Turquia (Türkiye)
- Ainda não está recrutando
- Taksim Training and Research Hospital
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Contato:
- celal kaya, MD
- Número de telefone: 90 5435176760
- E-mail: celalmadime@gmail.com
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Contato:
- Guray Demir, Proffesor
- Número de telefone: 90 5052113989
- E-mail: guraydemir@gmail.com
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-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Comparador Ativo: 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 Ativo: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Spinal Anesthesia Convenience Score (SACS)
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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First-Attempt Success of Spinal Anesthesia
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Celal Kaya, Taksim Training and Research Hospital
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- 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.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
22 de julho de 2026
Conclusão Primária (Estimado)
14 de dezembro de 2026
Conclusão do estudo (Estimado)
22 de dezembro de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
6 de julho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
16 de julho de 2026
Primeira postagem (Real)
21 de julho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
31 de julho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
29 de julho de 2026
Última verificação
1 de julho de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Ferimentos e Lesões
- Lesões nas pernas
- Fraturas, Osso
- Fraturas Femorais
- Lesões do quadril
- Fraturas de quadril
- Produtos químicos orgânicos
- Anilides
- Amidas
- Compostos de anilina
- Aminas
- Anestesia e analgesia
- Sistema digestivo e fenômenos fisiológicos orais
- Anestesia, condução
- Anestesia
- Odontologia
- Fenômenos fisiológicos dentários
- Bupivacaína
- Anestesia, espinhal
- Oclusão dentária
Outros números de identificação do estudo
- E-48670771-514.99-317908988
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Descrição do plano 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.
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .