Autonomic and Immune Effects of Regional Anesthesia in Total Hip Arthroplasty (PENG neuromodu)
Effects of Three Regional Anesthesia Strategies on Autonomic Regulation, Systemic Inflammatory Response, and Postoperative Recovery Following Elective Total Hip Arthroplasty: A Prospective Randomized Double-Blind Trial
Surgical trauma activates the sympathetic nervous system and induces a systemic inflammatory response, both of which may adversely affect postoperative recovery. Regional anesthesia has traditionally been used for perioperative analgesia; however, emerging evidence suggests that peripheral nerve blocks may also modulate autonomic and immune pathways. This prospective randomized double-blind trial aims to compare three regional anesthesia strategies in patients undergoing elective total hip arthroplasty under spinal anesthesia and to determine their effects on autonomic regulation, systemic inflammatory response, postoperative pain, opioid consumption, quality of recovery, and early functional outcomes.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Total hip arthroplasty (THA) is associated with substantial surgical trauma, resulting in activation of the sympathetic nervous system and a systemic inflammatory response that may contribute to postoperative pain, delayed functional recovery, and perioperative complications. Although regional anesthesia techniques are widely used to improve postoperative analgesia, increasing evidence suggests that they may also influence autonomic regulation and neuroimmune interactions beyond their analgesic effects. The extent to which different regional anesthesia strategies modify perioperative autonomic and inflammatory responses remains incompletely understood.
This prospective, randomized, double-blind, controlled trial aims to compare three regional analgesic strategies in patients undergoing elective primary total hip arthroplasty under spinal anesthesia: ultrasound-guided pericapsular nerve group (PENG) block, local infiltration analgesia (LIA), and the combination of PENG block with LIA. All patients will receive standardized perioperative anesthetic and multimodal analgesic management, with the regional analgesic technique being the only study intervention.
The primary objective is to determine whether different regional anesthesia strategies differentially influence perioperative autonomic regulation and systemic inflammatory response. Autonomic function will be assessed using perioperative hemodynamic parameters and vasopressor requirements, while systemic inflammatory activation will be evaluated using routinely available inflammatory biomarkers, including the Systemic Immune-Inflammation Index (SII), neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), C-reactive protein (CRP), and other laboratory markers measured before and after surgery.
Secondary objectives include comparison of postoperative pain intensity at rest and during movement, opioid consumption, time to first rescue analgesia, quality of recovery assessed using the Quality of Recovery-15 (QoR-15) questionnaire, incidence of postoperative nausea and vomiting, time to first ambulation, length of hospital stay, patient satisfaction, and the incidence of postoperative complications.
The study is designed to determine whether combining peripheral nerve blockade with periarticular infiltration provides additive benefits not only for postoperative analgesia but also for modulation of autonomic-immune interactions and enhancement of postoperative recovery. The findings may improve understanding of peripheral nerve blocks as a form of perioperative neuromodulation and support optimization of regional anesthesia strategies in patients undergoing total hip arthroplasty.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Malgorzata Reysner, MD PhD
- Número de teléfono: +48 61 8310122
- Correo electrónico: mreysner@ump.edu.pl
Ubicaciones de estudio
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Poznan, Polonia, 62-701
- Poznan University of Medical Sciences
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Adults aged ≥18 years.
- Scheduled for elective primary total hip arthroplasty due to primary hip osteoarthritis.
- American Society of Anesthesiologists (ASA) physical status I-III.
- Planned spinal anesthesia with one of the study regional analgesia techniques.
- Ability to understand the study procedures and provide written informed consent.
Exclusion Criteria:
- Refusal or inability to provide written informed consent.
- Revision hip arthroplasty, simultaneous bilateral hip arthroplasty, or hip arthroplasty performed for an acute fracture.
- Known hypersensitivity to ropivacaine or other medications required for the study procedures.
- Contraindication to spinal anesthesia, PENG block, or local infiltration analgesia, including infection at the injection site or a coagulation disorder or antithrombotic treatment that precludes safe performance of the planned procedures.
- Pre-existing neurological or neuromuscular disease that substantially affects sensation or motor function in the operated limb or prevents reliable assessment of study outcomes.
- Cognitive impairment or a communication disorder that prevents understanding of the study procedures or reliable completion of pain assessments.
- A medical condition that, in the investigator's judgment, makes participation or the planned anesthetic procedures unsafe.
- Planned use of an additional regional analgesic technique outside the study protocol.
- Participation in another interventional study that could interfere with the assessment of the study outcomes.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: PENG Block
Ropivacaine for Pericapsular Nerve Group (PENG) Block |
Ultrasound-guided single-injection pericapsular nerve group (PENG) block performed before surgery using 20ml of 0.2% ropivacaine
Otros nombres:
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Experimental: Local Infiltration Analgesia (LIA)
Ropivacaine for Local Infiltration Analgesia |
Local infiltration analgesia is performed intraoperatively - 20ml 0.2% ropivacaine
Otros nombres:
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Experimental: Combined PENG Block + LIA
Ropivacaine for Pericapsular Nerve Group (PENG) block before surgery and Local Infiltration Analgesia (LIA) |
Ultrasound-guided single-injection pericapsular nerve group (PENG) block performed before surgery using 20ml of 0.2% ropivacaine
Otros nombres:
Local infiltration analgesia is performed intraoperatively - 20ml 0.2% ropivacaine
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Systemic Immune-Inflammation Index (SII)
Periodo de tiempo: 24 hours after surgery
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Comparison of the change in Systemic Immune-Inflammation Index from baseline to postoperative 24 hours among the three study groups. |
24 hours after surgery
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Neutrophil-to-Lymphocyte Ratio (NLR)
Periodo de tiempo: 24 hours after surgery
|
Comparison of the change in neutrophil-to-lymphocyte ratio among the three study groups. |
24 hours after surgery
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Neutrophil-to-Lymphocyte Ratio (NLR)
Periodo de tiempo: 12 hours after surgery
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Comparison of the change in neutrophil-to-lymphocyte ratio among the three study groups. |
12 hours after surgery
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Neutrophil-to-Lymphocyte Ratio (NLR)
Periodo de tiempo: 48 hours after surgery
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Comparison of the change in neutrophil-to-lymphocyte ratio among the three study groups. |
48 hours after surgery
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Platelet-to-Lymphocyte Ratio (PLR)
Periodo de tiempo: 24 hours after surgery
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Comparison of the change in platelet-to-lymphocyte ratio among the three study groups. |
24 hours after surgery
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Platelet-to-Lymphocyte Ratio (PLR)
Periodo de tiempo: 48 hours after surgery
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Comparison of the change in platelet-to-lymphocyte ratio among the three study groups. |
48 hours after surgery
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Platelet-to-Lymphocyte Ratio (PLR)
Periodo de tiempo: 12 hours after surgery
|
Comparison of the change in platelet-to-lymphocyte ratio among the three study groups. |
12 hours after surgery
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Postoperative pain intensity
Periodo de tiempo: 2 hours after surgery
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Comparison of postoperative pain intensity assessed using the Numeric Rating Scale (NRS; 0-10) at rest. |
2 hours after surgery
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Postoperative pain intensity at movement
Periodo de tiempo: 2 hours after surgery
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Comparison of postoperative pain intensity assessed using the Numeric Rating Scale (NRS; 0-10) at movement. |
2 hours after surgery
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Postoperative pain intensity at movement
Periodo de tiempo: 6 hours after surgery
|
Comparison of postoperative pain intensity assessed using the Numeric Rating Scale (NRS; 0-10) at movement. |
6 hours after surgery
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Postoperative pain intensity at movement
Periodo de tiempo: 12 hours after surgery
|
Comparison of postoperative pain intensity assessed using the Numeric Rating Scale (NRS; 0-10) at movement. |
12 hours after surgery
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Postoperative pain intensity at movement
Periodo de tiempo: 24 hours after surgery
|
Comparison of postoperative pain intensity assessed using the Numeric Rating Scale (NRS; 0-10) at movement. |
24 hours after surgery
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Postoperative pain intensity at movement
Periodo de tiempo: 48 hours after surgery
|
Comparison of postoperative pain intensity assessed using the Numeric Rating Scale (NRS; 0-10) at movement. |
48 hours after surgery
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Postoperative pain intensity
Periodo de tiempo: 6 hours after surgery
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Comparison of postoperative pain intensity assessed using the Numeric Rating Scale (NRS; 0-10) at rest. |
6 hours after surgery
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Postoperative pain intensity
Periodo de tiempo: 12 hours after surgery
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Comparison of postoperative pain intensity assessed using the Numeric Rating Scale (NRS; 0-10) at rest. |
12 hours after surgery
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Postoperative pain intensity
Periodo de tiempo: 24 hours after surgery
|
Comparison of postoperative pain intensity assessed using the Numeric Rating Scale (NRS; 0-10) at rest. |
24 hours after surgery
|
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Postoperative pain intensity
Periodo de tiempo: 48 hours after surgery
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Comparison of postoperative pain intensity assessed using the Numeric Rating Scale (NRS; 0-10) at rest. |
48 hours after surgery
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Postoperative opioid consumption
Periodo de tiempo: 48 hours after surgery
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Comparison of cumulative opioid consumption during the postoperative period, expressed as intravenous morphine milligram equivalents (MME). |
48 hours after surgery
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Time to first rescue analgesia
Periodo de tiempo: 48 hours after surgery
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Comparison of the time from the end of surgery to the first administration of rescue opioid analgesia. |
48 hours after surgery
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Systemic Immune-Inflammation Index (SII)
Periodo de tiempo: 24 hours after surgery
|
Comparison of the change in the Systemic Immune-Inflammation Index (SII) among the three study groups. |
24 hours after surgery
|
|
Systemic Immune-Inflammation Index (SII)
Periodo de tiempo: 12 hours after surgery
|
Comparison of the change in the Systemic Immune-Inflammation Index (SII) among the three study groups. |
12 hours after surgery
|
|
Systemic Immune-Inflammation Index (SII)
Periodo de tiempo: 48 hours after surgery
|
Comparison of the change in the Systemic Immune-Inflammation Index (SII) among the three study groups. |
48 hours after surgery
|
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C-reactive protein (CRP)
Periodo de tiempo: 12 hours after surgery
|
Comparison of postoperative C-reactive protein (CRP) concentrations among the three study groups. |
12 hours after surgery
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C-reactive protein (CRP)
Periodo de tiempo: 24 hours after surgery
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Comparison of postoperative C-reactive protein (CRP) concentrations among the three study groups. |
24 hours after surgery
|
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C-reactive protein (CRP)
Periodo de tiempo: 48 hours after surgery
|
Comparison of postoperative C-reactive protein (CRP) concentrations among the three study groups. |
48 hours after surgery
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- 18/2026
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
De-identified individual participant data underlying the published results will be made available upon reasonable request to the corresponding author. Data will be shared after publication of the primary study results and following approval of a methodologically sound research proposal and completion of a data sharing agreement.
Marco de tiempo para compartir IPD
Data will be available beginning 6 months after publication of the primary results and for a period of 5 years.
Criterios de acceso compartido de IPD
Researchers who provide a methodologically sound proposal aimed at achieving the objectives of the approved proposal will be granted access. Requests should be directed to the corresponding author. A data access agreement will be required prior to data release.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CÓDIGO_ANALÍTICO
Información sobre medicamentos y dispositivos, documentos del estudio
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