Knee Osteoarthritis
Conditions
Brief summary
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.
Detailed description
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, including the Pericapsular Nerve Group (PENG) block, 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 iPACK block with Adducto Canal Block on SII in hip arthroplasty has not been previously investigated. The primary objective of this study is to determine whether the PENG block 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.
Interventions
DRUGsodium 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
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
Sponsors
Poznan University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Systemic Inflammation Response Index (SIRI) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Systemic Inflammation Response Index (SIRI) | 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. |
| Aggregate Index of Systemic Inflammation (AISI) | 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. |
| Platelet Mass Index (PMI) | 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. |
| C-reactive Protein (CRP) Concentration | 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. |
| Postoperative Pain Intensity (NRS) | 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. |
| Opioid Consumption | 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. |
| Time to First Rescue Analgesia | 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. |
Countries
Poland
Contacts
CONTACTMalgorzata Reysner, MD PhD
STUDY_CHAIRMalgorzata Reysner, MD PhD
Poznań University of Medical Sciences
Outcome results
None listed