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Autonomic and Immune Effects of Regional Anesthesia in Total Hip Arthroplasty (PENG neuromodu)

3 novembre 2026 aggiornato da: Poznan University of Medical Sciences

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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Stimato)

165

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Malgorzata Reysner, MD PhD
  • Numero di telefono: +48 61 8310122
  • Email: mreysner@ump.edu.pl

Luoghi di studio

  • Polonia
      • Poznan, Polonia, 62-701
        • Poznan University of Medical Sciences

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 100 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: PENG Block

Ropivacaine for Pericapsular Nerve Group (PENG) Block
Droga: PENG Block

Ultrasound-guided single-injection pericapsular nerve group (PENG) block performed before surgery using 20ml of 0.2% ropivacaine

Altri nomi:
  • PENG
  • Blocco del gruppo nervoso pericapsulare
  • 0.2% Ropimol
Sperimentale: Local Infiltration Analgesia (LIA)

Ropivacaine for Local Infiltration Analgesia
Droga: LIA

Local infiltration analgesia is performed intraoperatively - 20ml 0.2% ropivacaine

Altri nomi:
  • Periarticular Infiltration Analgesia
  • 0.2% ropimol
Sperimentale: Combined PENG Block + LIA

Ropivacaine for Pericapsular Nerve Group (PENG) block before surgery and Local Infiltration Analgesia (LIA)
Droga: PENG Block

Ultrasound-guided single-injection pericapsular nerve group (PENG) block performed before surgery using 20ml of 0.2% ropivacaine

Altri nomi:
  • PENG
  • Blocco del gruppo nervoso pericapsulare
  • 0.2% Ropimol
Droga: LIA

Local infiltration analgesia is performed intraoperatively - 20ml 0.2% ropivacaine

Altri nomi:
  • Periarticular Infiltration Analgesia
  • 0.2% ropimol

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Systemic Immune-Inflammation Index (SII)
Lasso di tempo: 24 hours after surgery

Comparison of the change in Systemic Immune-Inflammation Index from baseline to postoperative 24 hours among the three study groups.
24 hours after surgery

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Neutrophil-to-Lymphocyte Ratio (NLR)
Lasso di tempo: 24 hours after surgery

Comparison of the change in neutrophil-to-lymphocyte ratio among the three study groups.
24 hours after surgery
Neutrophil-to-Lymphocyte Ratio (NLR)
Lasso di tempo: 12 hours after surgery

Comparison of the change in neutrophil-to-lymphocyte ratio among the three study groups.
12 hours after surgery
Neutrophil-to-Lymphocyte Ratio (NLR)
Lasso di tempo: 48 hours after surgery

Comparison of the change in neutrophil-to-lymphocyte ratio among the three study groups.
48 hours after surgery
Platelet-to-Lymphocyte Ratio (PLR)
Lasso di tempo: 24 hours after surgery

Comparison of the change in platelet-to-lymphocyte ratio among the three study groups.
24 hours after surgery
Platelet-to-Lymphocyte Ratio (PLR)
Lasso di tempo: 48 hours after surgery

Comparison of the change in platelet-to-lymphocyte ratio among the three study groups.
48 hours after surgery
Platelet-to-Lymphocyte Ratio (PLR)
Lasso di tempo: 12 hours after surgery

Comparison of the change in platelet-to-lymphocyte ratio among the three study groups.
12 hours after surgery
Postoperative pain intensity
Lasso di tempo: 2 hours after surgery

Comparison of postoperative pain intensity assessed using the Numeric Rating Scale (NRS; 0-10) at rest.
2 hours after surgery
Postoperative pain intensity at movement
Lasso di tempo: 2 hours after surgery

Comparison of postoperative pain intensity assessed using the Numeric Rating Scale (NRS; 0-10) at movement.
2 hours after surgery
Postoperative pain intensity at movement
Lasso di tempo: 6 hours after surgery

Comparison of postoperative pain intensity assessed using the Numeric Rating Scale (NRS; 0-10) at movement.
6 hours after surgery
Postoperative pain intensity at movement
Lasso di tempo: 12 hours after surgery

Comparison of postoperative pain intensity assessed using the Numeric Rating Scale (NRS; 0-10) at movement.
12 hours after surgery
Postoperative pain intensity at movement
Lasso di tempo: 24 hours after surgery

Comparison of postoperative pain intensity assessed using the Numeric Rating Scale (NRS; 0-10) at movement.
24 hours after surgery
Postoperative pain intensity at movement
Lasso di tempo: 48 hours after surgery

Comparison of postoperative pain intensity assessed using the Numeric Rating Scale (NRS; 0-10) at movement.
48 hours after surgery
Postoperative pain intensity
Lasso di tempo: 6 hours after surgery

Comparison of postoperative pain intensity assessed using the Numeric Rating Scale (NRS; 0-10) at rest.
6 hours after surgery
Postoperative pain intensity
Lasso di tempo: 12 hours after surgery

Comparison of postoperative pain intensity assessed using the Numeric Rating Scale (NRS; 0-10) at rest.
12 hours after surgery
Postoperative pain intensity
Lasso di tempo: 24 hours after surgery

Comparison of postoperative pain intensity assessed using the Numeric Rating Scale (NRS; 0-10) at rest.
24 hours after surgery
Postoperative pain intensity
Lasso di tempo: 48 hours after surgery

Comparison of postoperative pain intensity assessed using the Numeric Rating Scale (NRS; 0-10) at rest.
48 hours after surgery
Postoperative opioid consumption
Lasso di tempo: 48 hours after surgery

Comparison of cumulative opioid consumption during the postoperative period, expressed as intravenous morphine milligram equivalents (MME).
48 hours after surgery
Time to first rescue analgesia
Lasso di tempo: 48 hours after surgery

Comparison of the time from the end of surgery to the first administration of rescue opioid analgesia.
48 hours after surgery
Systemic Immune-Inflammation Index (SII)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 48 hours after surgery

Comparison of the change in the Systemic Immune-Inflammation Index (SII) among the three study groups.
48 hours after surgery
C-reactive protein (CRP)
Lasso di tempo: 12 hours after surgery

Comparison of postoperative C-reactive protein (CRP) concentrations among the three study groups.
12 hours after surgery
C-reactive protein (CRP)
Lasso di tempo: 24 hours after surgery

Comparison of postoperative C-reactive protein (CRP) concentrations among the three study groups.
24 hours after surgery
C-reactive protein (CRP)
Lasso di tempo: 48 hours after surgery

Comparison of postoperative C-reactive protein (CRP) concentrations among the three study groups.
48 hours after surgery

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Poznan University of Medical Sciences

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 dicembre 2026

Completamento primario (Stimato)

30 dicembre 2027

Completamento dello studio (Stimato)

1 gennaio 2028

Date di iscrizione allo studio

Primo inviato

29 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

3 novembre 2026

Primo Inserito (Effettivo)

9 novembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

9 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

3 novembre 2026

Ultimo verificato

1 novembre 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • 18/2026

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano 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.

Periodo di condivisione IPD

Data will be available beginning 6 months after publication of the primary results and for a period of 5 years.

Criteri di accesso alla condivisione 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 di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA
  • CODICE_ANALITICO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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