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Effects of Combined Pericapsular Nerve Group (PENG) and Lateral Femoral Cutaneous Nerve (LFCN) Blocks on Anaesthetic Requirements and Electroencephalographic Depth of Anaesthesia During Total Hip Arthroplasty (PENG-LFCN-EEG)

2 de noviembre de 2026 actualizado por: Kocaeli City Hospital

Effects of Combined Pericapsular Nerve Group (PENG) and Lateral Femoral Cutaneous Nerve (LFCN) Blocks on Anaesthetic Requirements and Electroencephalographic Depth of Anaesthesia During Total Hip Arthroplasty: A Randomized Controlled Trial

This prospective, randomized controlled trial aims to evaluate the effects of combined pericapsular nerve group (PENG) and lateral femoral cutaneous nerve (LFCN) blocks on intraoperative anaesthetic consumption and electroencephalographic (EEG)-derived anaesthetic depth in patients undergoing elective total hip arthroplasty.

A total of 50 adult patients will be randomly allocated to two groups: combined PENG and LFCN blocks followed by general anaesthesia, or general anaesthesia alone. Anaesthetic depth will be monitored using the SedLine EEG monitoring system.

The primary outcome will be intraoperative sevoflurane consumption. Secondary outcomes will include remifentanil consumption, EEG-derived parameters including Patient State Index (PSI) and suppression ratio, haemodynamic variables, and recovery characteristics.

The study aims to determine whether combined regional blocks reduce anaesthetic requirements while maintaining adequate EEG-guided anaesthetic depth.

Descripción general del estudio

Descripción detallada

Total hip arthroplasty is frequently associated with significant nociceptive stimulation during surgery. Regional anaesthesia techniques, including the pericapsular nerve group (PENG) block and lateral femoral cutaneous nerve (LFCN) block, may reduce intraoperative nociceptive input and consequently decrease anaesthetic and opioid requirements.

This prospective, randomized controlled trial will include 50 patients aged 18-65 years with American Society of Anesthesiologists (ASA) physical status I-II who are scheduled for elective total hip arthroplasty.

Patients will be randomly assigned in a 1:1 ratio to either an intervention group receiving combined ultrasound-guided PENG and LFCN blocks before general anaesthesia or a control group receiving general anaesthesia without preoperative regional blocks.

General anaesthesia will be administered using a standardized EEG-guided protocol. During induction, propofol will be titrated to achieve a target Patient State Index (PSI) of 25-50, as monitored by the SedLine system. Following tracheal intubation, anaesthesia will be maintained with sevoflurane, with continuous EEG monitoring to maintain the target PSI range.

The primary outcome will be intraoperative sevoflurane consumption. Secondary outcomes will include total remifentanil consumption, EEG-derived anaesthetic depth parameters, suppression ratio measurements, the occurrence and duration of burst suppression, intraoperative haemodynamic variables, and postoperative recovery characteristics.

By comparing anaesthetic consumption and EEG-derived parameters between the two groups, this study aims to evaluate the effects of combined PENG and LFCN blocks on intraoperative anaesthetic requirements and EEG-guided anaesthetic depth during total hip arthroplasty.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

50

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: AYSE SENCAN, M.D Anaesthesiology Specialist
  • Número de teléfono: +905078313235
  • Correo electrónico: draysesencan@gmail.com

Ubicaciones de estudio

    • Kocaeli
      • Köseköy, Kocaeli, Turquía (Türkiye), 41100
        • Kocaeli City Hospital
        • Contacto:
          • AYSE SENCAN, M.D Anaesthesiology Specialist
          • Número de teléfono: +905078313235
          • Correo electrónico: draysesencan@gmail.com
        • Contacto:
          • Ayse Zeynep Turan Civraz, Associated Professor
          • Número de teléfono: +905054695850
          • Correo electrónico: ayse.zeynep@gmail.com

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

18 años a 65 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Patients aged 18-65 years
  • American Society of Anesthesiologists (ASA) physical status I-III
  • Scheduled for elective primary total hip arthroplasty
  • Undergoing general anaesthesia
  • Provision of written informed consent to participate in the study

Exclusion Criteria:

  • Known allergy to local anaesthetics
  • Contraindications to PENG or LFCN block
  • Infection at the planned block injection site
  • Coagulopathy or anticoagulant therapy considered unsuitable for regional anaesthesia
  • Chronic opioid use
  • Significant neurological disorders that may interfere with EEG assessment
  • Cognitive impairment preventing comprehension of the study protocol or provision of informed consent
  • Inability to perform SedLine monitoring
  • Inability to obtain written informed consent

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: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: PENG + LFCN Block Group

Patients in this group will receive ultrasound-guided pericapsular nerve group (PENG) and lateral femoral cutaneous nerve (LFCN) blocks before general anaesthesia. General anaesthesia will be induced with propofol titrated according to EEG-derived Patient State Index (PSI) values and maintained with sevoflurane, targeting a PSI range of 25-50.

Ultrasound-guided pericapsular nerve group (PENG) and lateral femoral cutaneous nerve (LFCN) blocks will be performed before induction of general anaesthesia. Both blocks will be administered as part of a combined regional anaesthesia technique to provide perioperative analgesia during total hip arthroplasty.

Comparador activo: No Intervention Group

Patients in this group will undergo general anaesthesia without preoperative peripheral nerve blocks. General anaesthesia will be induced with propofol titrated according to EEG-derived Patient State Index (PSI) values and maintained with sevoflurane, targeting a PSI range of 25-50.

General anaesthesia will be induced with propofol titrated according to EEG-derived Patient State Index (PSI) values and maintained with sevoflurane, targeting a PSI range of 25-50. Remifentanil will be administered intraoperatively according to a standardized anaesthetic protocol.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Intraoperative Sevoflurane Consumption (ml/h)
Periodo de tiempo: From initiation of sevoflurane administration after tracheal intubation until discontinuation of sevoflurane at the end of surgery.

Intraoperative sevoflurane consumption will be recorded in millilitres (mL) using the anaesthesia workstation. Hourly sevoflurane consumption will be calculated by dividing the total consumption by the duration of sevoflurane administration in hours.

From initiation of sevoflurane administration after tracheal intubation until discontinuation of sevoflurane at the end of surgery.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Weight-Adjusted Intraoperative Remifentanil Consumption (µg/kg/h)
Periodo de tiempo: From initiation to discontinuation of remifentanil infusion during general anaesthesia.

Weight-adjusted hourly remifentanil consumption will be determined by dividing the total administered remifentanil dose (µg) by patient body weight (kg) and the duration of remifentanil infusion in hours.

From initiation to discontinuation of remifentanil infusion during general anaesthesia.
Mean Intraoperative Patient State Index (PSI)
Periodo de tiempo: From initiation of sevoflurane administration after tracheal intubation until discontinuation of sevoflurane at the end of surgery.

The mean Patient State Index (PSI) during sevoflurane anaesthesia will be determined using continuous EEG monitoring data obtained from the SedLine system.

From initiation of sevoflurane administration after tracheal intubation until discontinuation of sevoflurane at the end of surgery.
Mean Intraoperative Suppression Ratio (SR)
Periodo de tiempo: From initiation of sevoflurane administration after tracheal intubation until discontinuation of sevoflurane at the end of surgery.

The mean suppression ratio (SR) will be determined using continuous EEG monitoring data obtained from the SedLine system during sevoflurane anaesthesia and expressed as a percentage (%).

From initiation of sevoflurane administration after tracheal intubation until discontinuation of sevoflurane at the end of surgery.
Percentage of Time With Suppression Ratio Above 5%
Periodo de tiempo: From initiation of sevoflurane administration after tracheal intubation until discontinuation of sevoflurane at the end of surgery.

The percentage of time during which the suppression ratio (SR) exceeds 5% will be determined using continuous EEG monitoring data obtained from the SedLine system during sevoflurane anaesthesia.

From initiation of sevoflurane administration after tracheal intubation until discontinuation of sevoflurane at the end of surgery.
Time to Extubation (min)
Periodo de tiempo: From discontinuation of sevoflurane administration until tracheal extubation.

Time to extubation will be defined as the interval between discontinuation of sevoflurane administration and removal of the endotracheal tube, expressed in minutes.

From discontinuation of sevoflurane administration until tracheal extubation.
Postoperative Richmond Agitation-Sedation Scale (RASS) Score
Periodo de tiempo: At 10, 15, 30, and 45 minutes after admission to the post-anaesthesia care unit (PACU).

Postoperative sedation and agitation will be assessed using the Richmond Agitation-Sedation Scale (RASS) at 10, 15, 30, and 45 minutes after admission to the post-anaesthesia care unit (PACU). Scores range from -5 (unarousable) to +4 (combative), with 0 indicating an alert and calm state.

At 10, 15, 30, and 45 minutes after admission to the post-anaesthesia care unit (PACU).
Postoperative Nursing Delirium Screening Scale (NuDESC) Score
Periodo de tiempo: At 10, 15, 30, and 45 minutes after admission to the post-anaesthesia care unit (PACU).

Postoperative delirium-related symptoms will be assessed using the Nursing Delirium Screening Scale (NuDESC) at 10, 15, 30, and 45 minutes after admission to the post-anaesthesia care unit (PACU). Scores range from 0 to 10, with higher scores indicating more pronounced delirium-related symptoms.

At 10, 15, 30, and 45 minutes after admission to the post-anaesthesia care unit (PACU).

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Publicaciones y enlaces útiles

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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 (Estimado)

1 de diciembre de 2026

Finalización primaria (Estimado)

1 de mayo de 2027

Finalización del estudio (Estimado)

1 de mayo de 2027

Fechas de registro del estudio

Enviado por primera vez

23 de octubre de 2026

Primero enviado que cumplió con los criterios de control de calidad

23 de octubre de 2026

Publicado por primera vez (Actual)

29 de octubre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

4 de noviembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

2 de noviembre de 2026

Última verificación

1 de octubre de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • PENG-LFCN-THA-2026

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

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. .

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