SII Levels Following PENG Block in Hip Arthroplasty
ConditionHip Osteoarthritis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65-100
SponsorPoznan University of Medical Sciences
About this trial
This randomized controlled trial evaluates the effect of ultrasound-guided Pericapsular Nerve Group (PENG) block 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 PENG block attenuates the systemic inflammatory reaction to surgical trauma compared to sham block.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with ASA classification I-III
Aged 65-100 years
Who will be scheduled for hip arthroplasty under spinal anesthesia
Disqualifiers
Patients who have a history of bleeding diathesis
Take anticoagulant therapy
History of chronic pain before surgery
Multiple trauma
Trial design
Design model
Parallel
Treatments tested in this trial
sodium Chloride
DrugAfter spinal anesthesia, the ultrasound-guided PENG block will be performed with 20ml of 0.9% sodium chloride
Ropivacaine 0.2% Injectable Solution
DrugAfter spinal anesthesia, the ultrasound-guided PENG block will be performed with 20 ml of 0.2% ropivacaine
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Sham blocksSham comparator 1 intervention
Group B: PENG blockActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Systemic Inflammation Response Index (SIRI)
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.
Time frame
12 hours after surgerySecondary outcomes
1
Systemic Inflammation Response Index (SIRI)
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.
Time frame
24 hours after surgery2
Systemic Inflammation Response Index (SIRI)
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.
Time frame
48 hours after surgery3
Aggregate Index of Systemic Inflammation (AISI)
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.
Time frame
12 hours after surgery4
Aggregate Index of Systemic Inflammation (AISI)
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.
Time frame
24 hours after surgerySponsors and contacts
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Source ClinicalTrials.gov