SII Levels Following PENG Block in Hip Arthroplasty
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: sodium Chloride, Ropivacaine 0.2% Injectable Solution.
- Who it may be relevant to
- Registry conditions: Hip Osteoarthritis. Basic parameters: 65 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Poland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Pericapsular Nerve Group Block Mitigates Surgical Stress and Enhances Analgesia in Total Hip Arthroplasty: A Randomized Controlled Trial
Overview
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.
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 inflammatory cascade activation. While previous studies have evaluated the impact of regional anesthesia on NLR and PLR, the influence of PENG block on SII in hip arthroplasty has not been previously investigated.
The primary objective of this study is to determine whether PENG block reduces postoperative SII levels compared with 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
- Drug sodium Chloride
After spinal anesthesia, the ultrasound-guided PENG block will be performed with 20ml of 0.9% sodium chloride - Drug Ropivacaine 0.2% Injectable Solution
After spinal anesthesia, the ultrasound-guided PENG block will be performed with 20 ml of 0.2% ropivacaine
Primary outcome measures
- Systemic Inflammation Response Index (SIRI) [Time frame: 12 hours after surgery]
Secondary outcome measures (12)
- Systemic Inflammation Response Index (SIRI) [Time frame: 24 hours after surgery]
- Systemic Inflammation Response Index (SIRI) [Time frame: 48 hours after surgery]
- Aggregate Index of Systemic Inflammation (AISI) [Time frame: 12 hours after surgery]
- Aggregate Index of Systemic Inflammation (AISI) [Time frame: 24 hours after surgery]
- Aggregate Index of Systemic Inflammation (AISI) [Time frame: 48 hours after surgery]
- Platelet Mass Index (PMI) [Time frame: 12 hours after surgery]
- Platelet Mass Index (PMI) [Time frame: 24 hours after surgery]
- Platelet Mass Index (PMI) [Time frame: 48 hours after surgery]
- C-reactive Protein (CRP) Concentration [Time frame: 12 hours after surgery]
- C-reactive Protein (CRP) Concentration [Time frame: 24 hours after surgery]
- C-reactive Protein (CRP) Concentration [Time frame: 48 hours after surgery]
- Postoperative Pain Intensity (NRS) [Time frame: 4 hours after surgery]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Poland · 1 center
- Poznan University of Medical Sciences — Poznan
Identifiers
NCT: NCT07449403 · 80/26