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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Malgorzata Reysner, MD PhD
- Telefonní číslo: +48 61 8310122
- E-mail: mreysner@ump.edu.pl
Studijní místa
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Poznan, Polsko, 62-701
- Poznan University of Medical Sciences
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Čtyřnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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
Ostatní jména:
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Experimentální: Local Infiltration Analgesia (LIA)
Ropivacaine for Local Infiltration Analgesia |
Local infiltration analgesia is performed intraoperatively - 20ml 0.2% ropivacaine
Ostatní jména:
|
|
Experimentální: 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
Ostatní jména:
Local infiltration analgesia is performed intraoperatively - 20ml 0.2% ropivacaine
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in Systemic Immune-Inflammation Index (SII)
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Neutrophil-to-Lymphocyte Ratio (NLR)
Časové okno: 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)
Časové okno: 12 hours after surgery
|
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)
Časové okno: 48 hours after surgery
|
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)
Časové okno: 24 hours after surgery
|
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)
Časové okno: 48 hours after surgery
|
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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 6 hours after surgery
|
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
Časové okno: 12 hours after surgery
|
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
Časové okno: 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
Časové okno: 48 hours after surgery
|
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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 24 hours after surgery
|
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)
Časové okno: 48 hours after surgery
|
Comparison of postoperative C-reactive protein (CRP) concentrations among the three study groups. |
48 hours after surgery
|
Spolupracovníci a vyšetřovatelé
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- 18/2026
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu 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.
Časový rámec sdílení IPD
Data will be available beginning 6 months after publication of the primary results and for a period of 5 years.
Kritéria přístupu pro sdílení 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.
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- MÍZA
- ANALYTIC_CODE
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