SII Levels Following PENG Block in Hip Arthroplasty
Pericapsular Nerve Group Block Mitigates Surgical Stress and Enhances Analgesia in Total Hip Arthroplasty: A Randomized Controlled Trial
1 other identifier
interventional
60
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2026
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 27, 2026
CompletedFirst Posted
Study publicly available on registry
March 4, 2026
CompletedStudy Start
First participant enrolled
April 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
ExpectedMarch 4, 2026
February 1, 2026
1 month
February 27, 2026
February 27, 2026
Conditions
Outcome Measures
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.
12 hours after surgery
Secondary Outcomes (18)
Systemic Inflammation Response Index (SIRI)
24 hours after surgery
Systemic Inflammation Response Index (SIRI)
48 hours after surgery
Aggregate Index of Systemic Inflammation (AISI)
12 hours after surgery
Aggregate Index of Systemic Inflammation (AISI)
24 hours after surgery
Aggregate Index of Systemic Inflammation (AISI)
48 hours after surgery
- +13 more secondary outcomes
Study Arms (2)
Sham blocks
SHAM COMPARATORPENG block with 20ml of 0.9% sodium chloride
PENG block
ACTIVE COMPARATORPENG block with 20ml 0f 0.2% ropivacaine
Interventions
After spinal anesthesia, the ultrasound-guided PENG block will be performed with 20 ml of 0.2% ropivacaine
After spinal anesthesia, the ultrasound-guided PENG block will be performed with 20ml of 0.9% sodium chloride
Eligibility Criteria
You may qualify if:
- Patients with ASA classification I-III
- Aged 65-100 years
- Who will be scheduled for hip arthroplasty under spinal anesthesia
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 27, 2026
First Posted
March 4, 2026
Study Start
April 1, 2026
Primary Completion
May 1, 2026
Study Completion (Estimated)
June 30, 2026
Last Updated
March 4, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ANALYTIC CODE
- Time Frame
- Data will become available 6 months after publication of the primary results and will remain available for 5 years.
- Access Criteria
- Access will be granted to researchers who provide: A methodologically sound research proposal Institutional affiliation Ethical approval (if required) A signed data use agreement Requests should be directed to the principal investigator via institutional email.
De-identified individual participant data (IPD) underlying the results reported in publications (including demographic data, laboratory inflammatory indices such as SII, SIRI, AISI, CRP values, pain scores, opioid consumption, and time-to-event outcomes) will be made available to qualified researchers. Data will be shared after removal of all direct identifiers in accordance with GDPR regulations and institutional data protection policies. The study protocol, statistical analysis plan (SAP), and analytic code will also be available upon reasonable request. Data will be provided for the purpose of secondary analyses, meta-analyses, or validation studies, subject to approval by the principal investigator and institutional review board, where applicable.