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Niveaux de SII après bloc iPACK avec bloc du canal adducteur dans l'arthroplastie du genou

3 novembre 2026 mis à jour par: Poznan University of Medical Sciences

iPACK Block With Adductor Canal Block Mitigates Surgical Stress and Enhances Analgesia in Total Knee Arthroplasty: A Randomized Controlled Trial

This randomized controlled trial evaluates the effect of ultrasound-guided iPACK block with Adductor Canal Block (ACB) on the Systemic Immune-Inflammation Index (SII) in elderly patients undergoing total hip arthroplasty under spinal anesthesia. SII, calculated as platelet × neutrophil / lymphocyte count, is used as a composite marker of perioperative inflammatory and immune response. The study investigates whether iPACK block with ACB attenuates the systemic inflammatory reaction to surgical trauma compared to sham block.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

Surgical trauma induces a systemic inflammatory response characterized by neutrophilia, lymphopenia, and platelet activation. These hematologic alterations reflect the interaction between innate immune activation, stress-induced immunosuppression, and pro-thrombotic mechanisms. The modulation of this response may influence postoperative recovery and complication risk.

The Systemic Immune-Inflammation Index (SII) is calculated using the formula:

SII = (Platelet count × Neutrophil count) / Lymphocyte count SII integrates three components of systemic inflammation and immune regulation and is considered a more comprehensive marker than isolated ratios such as neutrophil-to-lymphocyte ratio (NLR) or platelet-to-lymphocyte ratio (PLR). Compared with NLR and PLR, SII may better reflect the balance between inflammatory activation and adaptive immune suppression in the perioperative period.

Regional anesthesia techniques may attenuate surgical stress by reducing afferent nociceptive signaling, sympathetic activation, and subsequent activation of the inflammatory cascade. While previous studies have evaluated the impact of regional anesthesia on NLR and PLR, the influence of the iPACK block with Adductor Canal Block on SII in hip arthroplasty has not been previously investigated.

The primary objective of this study is to determine whether the iPACK block with ACB reduces postoperative SII levels compared with the sham block in elderly patients undergoing total hip arthroplasty under spinal anesthesia.

Peripheral venous blood samples will be collected preoperatively and at predefined postoperative time points (e.g., 12, 24, and 48 hours). The primary endpoint will be postoperative SII at 24 hours or the change from baseline (ΔSII), depending on statistical analysis plan.

This study aims to determine whether motor-sparing regional anesthesia may modulate systemic inflammatory response beyond analgesic effects, potentially contributing to improved perioperative outcomes.

Type d'étude

Interventionnel

Inscription (Estimé)

60

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Malgorzata Reysner, MD PhD
  • Numéro de téléphone: +48 501 056 924
  • E-mail: mreysner@ump.edu.pl

Sauvegarde des contacts de l'étude

  • Nom: Malgorzata Reysner, MD PhD
  • Numéro de téléphone: +48 61 83 10 122
  • E-mail: mreysner@ump.edu.pl

Lieux d'étude

  • Pologne
      • Poznan, Pologne, 62-701
        • Recrutement
        • Poznan University of Medical Sciences
        • Contact:
          • Malgorzata Reysner, M.D. Ph.D.
          • Numéro de téléphone: +48 61 873 83 03
          • E-mail: mreysner@ump.edu.pl

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

65 ans à 100 ans (Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • Patients with ASA classification I-III
  • Aged 65-100 years
  • Who will be scheduled for hip arthroplasty under spinal anesthesia

Exclusion Criteria:

  • Patients who have a history of bleeding diathesis
  • Take anticoagulant therapy
  • History of chronic pain before surgery
  • Multiple trauma
  • patients unable to assess their pain (dementia)
  • patients operated under general anesthesia
  • patients having an infection in the region of the procedure
  • the patient who does not accept the procedure

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Quadruple

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur placebo: Sham blocks

iPACK block with 20ml of 0.9% sodium chloride and ACB with 20ml of 0.9% sodium chloride
Médicament: sodium Chloride

After spinal anesthesia, the ultrasound-guided iPACK block will be performed with 20ml of 0.9% sodium chloride; and Adductor Canal Block will be performed with 20ml of 0.9% sodium chloride

Autres noms:
  • 0,9 % de NaCl
Comparateur actif: iPACK block with ACB

iPACK block with 20ml of 0.2% ropivacaine and ACB with 20ml of 0.2% ropivacaine
Médicament: Ropivacaine Hydrocloride

After spinal anesthesia, the ultrasound-guided iPACK block will be performed with 20ml of 0.2% ropivacaine, and the Adductor Canal Block will be performed with 20ml of 0.2% ropivacaine

Autres noms:
  • 0,2 % de ropivacaïne

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Systemic Inflammation Response Index (SIRI)
Délai: 12 hours after surgery

Systemic Inflammation Response Index (SIRI) is used as a composite marker of systemic inflammatory activation. It is calculated from peripheral venous blood samples using the formula:

SIRI = (Neutrophil count × Monocyte count) / Lymphocyte count All parameters are obtained from routine complete blood count (CBC) analysis and expressed in ×10⁹/L.

SIRI reflects the interaction between innate immune activation (neutrophils and monocytes) and adaptive immune suppression (lymphocytes). Higher SIRI values indicate greater systemic inflammatory response.
12 hours after surgery

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Systemic Inflammation Response Index (SIRI)
Délai: 24 hours after surgery

Systemic Inflammation Response Index (SIRI) is used as a composite marker of systemic inflammatory activation. It is calculated from peripheral venous blood samples using the formula:

SIRI = (Neutrophil count × Monocyte count) / Lymphocyte count All parameters are obtained from routine complete blood count (CBC) analysis and expressed in ×10⁹/L.

SIRI reflects the interaction between innate immune activation (neutrophils and monocytes) and adaptive immune suppression (lymphocytes). Higher SIRI values indicate greater systemic inflammatory response.
24 hours after surgery
Systemic Inflammation Response Index (SIRI)
Délai: 48 hours after surgery

Systemic Inflammation Response Index (SIRI) is used as a composite marker of systemic inflammatory activation. It is calculated from peripheral venous blood samples using the formula:

SIRI = (Neutrophil count × Monocyte count) / Lymphocyte count All parameters are obtained from routine complete blood count (CBC) analysis and expressed in ×10⁹/L.

SIRI reflects the interaction between innate immune activation (neutrophils and monocytes) and adaptive immune suppression (lymphocytes). Higher SIRI values indicate greater systemic inflammatory response.
48 hours after surgery
Aggregate Index of Systemic Inflammation (AISI)
Délai: 12 hours after surgery

Aggregate Index of Systemic Inflammation (AISI) is calculated as:

AISI = (Neutrophil count × Monocyte count × Platelet count) / Lymphocyte count All values are obtained from routine CBC and expressed in ×10⁹/L. AISI integrates neutrophils, monocytes, platelets, and lymphocytes, providing a broader assessment of systemic inflammatory and immune response compared to single ratios.
12 hours after surgery
Aggregate Index of Systemic Inflammation (AISI)
Délai: 24 hours after surgery

Aggregate Index of Systemic Inflammation (AISI) is calculated as:

AISI = (Neutrophil count × Monocyte count × Platelet count) / Lymphocyte count All values are obtained from routine CBC and expressed in ×10⁹/L. AISI integrates neutrophils, monocytes, platelets, and lymphocytes, providing a broader assessment of systemic inflammatory and immune response compared to single ratios.
24 hours after surgery
Aggregate Index of Systemic Inflammation (AISI)
Délai: 48 hours after surgery

Aggregate Index of Systemic Inflammation (AISI) is calculated as:

AISI = (Neutrophil count × Monocyte count × Platelet count) / Lymphocyte count All values are obtained from routine CBC and expressed in ×10⁹/L. AISI integrates neutrophils, monocytes, platelets, and lymphocytes, providing a broader assessment of systemic inflammatory and immune response compared to single ratios.
48 hours after surgery
Platelet Mass Index (PMI)
Délai: 12 hours after surgery

Platelet Mass Index (PMI) reflects total circulating platelet mass and is calculated as:

PMI = Platelet count × Mean Platelet Volume (MPV) Platelet count is expressed in ×10⁹/L and MPV in femtoliters (fL). PMI reflects platelet activation and thrombo-inflammatory potential, which may increase in response to surgical stress.
12 hours after surgery
Platelet Mass Index (PMI)
Délai: 24 hours after surgery

Platelet Mass Index (PMI) reflects total circulating platelet mass and is calculated as:

PMI = Platelet count × Mean Platelet Volume (MPV) Platelet count is expressed in ×10⁹/L and MPV in femtoliters (fL). PMI reflects platelet activation and thrombo-inflammatory potential, which may increase in response to surgical stress.
24 hours after surgery
Platelet Mass Index (PMI)
Délai: 48 hours after surgery

Platelet Mass Index (PMI) reflects total circulating platelet mass and is calculated as:

PMI = Platelet count × Mean Platelet Volume (MPV) Platelet count is expressed in ×10⁹/L and MPV in femtoliters (fL). PMI reflects platelet activation and thrombo-inflammatory potential, which may increase in response to surgical stress.
48 hours after surgery
C-reactive Protein (CRP) Concentration
Délai: 12 hours after surgery

C-reactive protein (CRP) is a laboratory marker of acute systemic inflammation measured in peripheral venous blood samples.

CRP concentration is expressed in mg/L and determined using standard hospital laboratory methods.

Higher CRP values indicate greater postoperative inflammatory response.
12 hours after surgery
C-reactive Protein (CRP) Concentration
Délai: 24 hours after surgery

C-reactive protein (CRP) is a laboratory marker of acute systemic inflammation measured in peripheral venous blood samples.

CRP concentration is expressed in mg/L and determined using standard hospital laboratory methods.

Higher CRP values indicate greater postoperative inflammatory response.
24 hours after surgery
C-reactive Protein (CRP) Concentration
Délai: 48 hours after surgery

C-reactive protein (CRP) is a laboratory marker of acute systemic inflammation measured in peripheral venous blood samples.

CRP concentration is expressed in mg/L and determined using standard hospital laboratory methods.

Higher CRP values indicate greater postoperative inflammatory response.
48 hours after surgery
Postoperative Pain Intensity (NRS)
Délai: 4 hours after surgery

Postoperative pain intensity will be assessed using the Numerical Rating Scale (NRS), ranging from 0 to 10, where:

0 = no pain 10 = worst pain imaginable Pain scores will be recorded at rest.
4 hours after surgery
Postoperative Pain Intensity (NRS)
Délai: 8 hours after surgery

Postoperative pain intensity will be assessed using the Numerical Rating Scale (NRS), ranging from 0 to 10, where:

0 = no pain 10 = worst pain imaginable Pain scores will be recorded at rest.
8 hours after surgery
Postoperative Pain Intensity (NRS)
Délai: 12 hours after surgery

Postoperative pain intensity will be assessed using the Numerical Rating Scale (NRS), ranging from 0 to 10, where:

0 = no pain 10 = worst pain imaginable Pain scores will be recorded at rest.
12 hours after surgery
Postoperative Pain Intensity (NRS)
Délai: 24 hours after surgery

Postoperative pain intensity will be assessed using the Numerical Rating Scale (NRS), ranging from 0 to 10, where:

0 = no pain 10 = worst pain imaginable Pain scores will be recorded at rest.
24 hours after surgery
Postoperative Pain Intensity (NRS)
Délai: 48 hours after surgery

Postoperative pain intensity will be assessed using the Numerical Rating Scale (NRS), ranging from 0 to 10, where:

0 = no pain 10 = worst pain imaginable Pain scores will be recorded at rest.
48 hours after surgery
Opioid Consumption
Délai: 48 hours after surgery

Total opioid consumption within the first 48 hours after surgery will be recorded.

All administered opioids will be converted to intravenous morphine milligram equivalents (MME) for standardization.

Higher cumulative MME indicates greater analgesic requirement.
48 hours after surgery
Time to First Rescue Analgesia
Délai: 48 hours after surgery

Time from completion of surgery to first administration of rescue opioid analgesia.

Measured in minutes. Shorter time indicates earlier breakthrough pain.
48 hours after surgery

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Poznan University of Medical Sciences

Les enquêteurs

  • Chaise d'étude: Malgorzata Reysner, MD PhD, Poznań University of Medical Sciences

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 mars 2026

Achèvement primaire (Estimé)

30 novembre 2026

Achèvement de l'étude (Estimé)

1 décembre 2026

Dates d'inscription aux études

Première soumission

27 février 2026

Première soumission répondant aux critères de contrôle qualité

27 février 2026

Première publication (Réel)

4 mars 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

5 novembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

3 novembre 2026

Dernière vérification

1 novembre 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 81/26

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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