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PENG+LFCN Block vs QIPB for Total Hip Arthroplasty

20 de junio de 2026 actualizado por: Mustafa Kılın, Antalya City Hospital

Comparison Between Quadro-iliac Plane Block (QIPB) and Pericapsular Nerve Group (PENG) Block Combined With Lateral Femoral Cutaneous Nerve Block for Total Hip Arthroplasty: a Randomized Controlled Trial

This randomized clinical trial aims to evaluate and compare the analgesic efficacy and functional outcomes of the quadro-iliac plane block (QIPB) and the pericapsular nerve group (PENG) block combined with lateral femoral cutaneous nerve(LFCN) block in patients undergoing total hip arthroplasty. The primary outcome is the Numeric Rating Scale (NRS) within the first 48 hours after surgery. Secondary outcomes include postoperative total opioid consumption, ıncidence of quadriceps motor block, time to first ambulation, block performance time, falls, length of hospital stay, block- related complications(hematoma,local anesthetic systemic complications, vascular puncture, and infection), patient satisfaction assessed using a Likert scale, and incidence of postoperative nausea and vomiting.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

Materials and Methods:

This prospective, randomized clinical trial will include patients aged 18-80 years with American Society of Anesthesiologists (ASA) physical status I-III who are scheduled to undergo elective unilateral primary total hip arthroplasty unde spinal anesthesia. Before enrollment, all patients will be informed about the study protocol and written informed consent will be obtained. Patients will be instructed on the use of the Numeric Rating Scale (NRS) for postoperative pain assessment, where 0 represents no pain and 10 represents the worst pain imaginable.

Patients with contraindications to spinal anesthesia, allergy to local anesthetics, coagulopathy, infection at the injection site, chronic opioid use, pre-existing neurological deficits involving the lower extremities, cognitive impairment preventing reliable communication, revision or bilateral hip arthroplasty, and refusal to participate will be excluded from the study.

Patients will be randomly allocated to one of two study groups using a computer-generated randomization sequence (https://www.randomizer.org). Randomization will be performed by a team member not involved in patient management or outcome assessment. Allocation concealment will be achieved using sequentially numbered sealed opaque envelopes, which will be opened immediately before block performance.

Upon arrival in the operating room, standard monitoring including electrocardiography, non-invasive blood pressure measurement, and pulse oximetry will be applied. Following intravenous access and preloading according to institutional practice, spinal anesthesia will be performed at the L3-L4 or L4-L5 intervertebral space using a 25-gauge Quincke spinal needle under aseptic conditions. After confirmation of free cerebrospinal fluid flow, 12-15 mg of 0.5% hyperbaric bupivacaine will be administered intrathecally. Supplemental sedation with intravenous midazolam and/or propofol may be provided when required for patient comfort.

Following successful spinal anesthesia, patients will receive either ultrasound-guided quadro-iliac plane block (QIPB) or ultrasound-guided pericapsular nerve group (PENG) block combined with lateral femoral cutaneous nerve block according to group allocation. All blocks will be performed by anesthesiologists experienced in regional anesthesia and familiar with both techniques.

All patients will receive the same multimodal postoperative analgesic regimen and standardized postoperative rehabilitation protocol. Postoperative pain scores at rest and during movement will be assessed using the NRS during the first 48 postoperative hours. Opioid consumption, incidence of quadriceps motor block, time to first ambulation, patient satisfaction, postoperative nausea and vomiting, falls, length of hospital stay, block performance time, and block-related complications will also be recorded.

Outcome assessments will be performed by investigators who are unaware of group allocation.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

60

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: MUSTAFA KILIN, Consultant Anesthesiologists
  • Número de teléfono: +905464569218
  • Correo electrónico: mustafa.kilin90@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

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

  • Age between 18 and 80 years
  • American Society of Anesthesiologists physical status I-III
  • Scheduled for elective unilateral primary total hip arthroplasty
  • Surgery planned under spinal anesthesia
  • Ability to understand and use the Numeric Rating Scale
  • Written informed consent provided

Exclusion Criteria:

  • Refusal to participate
  • Revision total hip arthroplasty
  • Bilateral total hip arthroplasty
  • Contraindication to spinal anesthesia
  • Contraindication to peripheral nerve block
  • Known allergy to local anesthetics or study drugs
  • Coagulopathy or anticoagulant use incompatible with neuraxial/regional anesthesia
  • Infection at the block injection site
  • Pre-existing neurological deficit involving the operative lower extremity
  • Peripheral neuropathy
  • Chronic opioid use
  • Cognitive impairment or inability to communicate reliably
  • Severe hepatic or renal failure
  • Body mass index >35 kg/m²
  • Pregnancy

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: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: quadro-iliac plane block (QIPB)
Participants allocated to the QIPB group will receive an ultrasound-guided quadro-iliac plane block after spinal anesthesia. Following standard aseptic preparation, 30 mL of 0.25% bupivacaine will be administered into the target fascial plane under ultrasound guidance after confirming the absence of blood on aspiration.
Comparador activo: pericapsular nerve group (PENG) block combined with lateral femoral cutaneous nerve block
Participants in the PENG group will undergo an ultrasound-guided pericapsular nerve group (PENG) block after spinal anesthesia. A total of 20 mL of 0.25% bupivacaine will be administered.
Participants in the LFCN group will undergo an ultrasound-guided lateral femoral cutaneous nerve block after spinal anesthesia. A total of 10 mL of 0.25% bupivacaine will be administered.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Postoperative pain scores
Periodo de tiempo: Postoperative 6, 24, 36, and 48 hours
Postoperative pain intensity will be assessed using an 11-point Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst imaginable pain. Pain scores at rest will be recorded in the post-anesthesia care unit and at postoperative 6, 24, 36, and 48 hours. Pain scores during movement will be assessed during passive flexion of the operated hip at postoperative 6, 24, 36, and 48 hours.
Postoperative 6, 24, 36, and 48 hours

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Postoperative opioid consumption
Periodo de tiempo: Postoperative 24 and 48 hours
Total postoperative opioid consumption will be recorded and cumulative opioid consumption will be calculated at postoperative 24 and 48 hours.
Postoperative 24 and 48 hours
Incidence of quadriceps motor block
Periodo de tiempo: Postoperative 3, 6, and 24 hours

Quadriceps motor block will be assessed using knee extension testing and graded as:

0 = normal strength

  1. = paresis
  2. = paralysis. Motor block incidence will be defined as the presence of paresis or paralysis.
Postoperative 3, 6, and 24 hours
Patient satisfaction
Periodo de tiempo: Postoperative 48 hours
Patient satisfaction with postoperative analgesia will be assessed using a Likert scale.
Postoperative 48 hours
Postoperative nausea and vomiting (PONV)
Periodo de tiempo: Postoperative 48 hours
Incidence of postoperative nausea and vomiting during the first 48 postoperative hours.
Postoperative 48 hours
Falls
Periodo de tiempo: Through postoperative day 2
Incidence of falls during the first 48 postoperative hours.
Through postoperative day 2
Length of hospital stay
Periodo de tiempo: Through hospital discharge, up to 30 days
Number of days from surgery to hospital discharge.
Through hospital discharge, up to 30 days
Time to first ambulation
Periodo de tiempo: Postoperative day 1
Time from the end of surgery to the first successful ambulation.
Postoperative day 1
Block performance time
Periodo de tiempo: Periprocedural
Time from ultrasound probe placement to completion of local anesthetic injection.
Periprocedural
Block-related complications
Periodo de tiempo: Through hospital discharge, up to 30 days
Hematoma Vascular puncture Local anesthetic systemic toxicity (LAST) Infection at the injection site
Through hospital discharge, up to 30 days

Colaboradores e Investigadores

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

Patrocinador

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)

15 de noviembre de 2026

Finalización primaria (Estimado)

15 de agosto de 2027

Finalización del estudio (Estimado)

15 de septiembre de 2027

Fechas de registro del estudio

Enviado por primera vez

13 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

20 de junio de 2026

Publicado por primera vez (Actual)

25 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

25 de junio de 2026

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

20 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Otros números de identificación del estudio

  • QİPBvsPENG+LFCN

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. .