SII Levels Following PENG Block in Hip Arthroplasty

February 27, 2026 updated by: Poznan University of Medical Sciences

Pericapsular Nerve Group Block Mitigates Surgical Stress and Enhances Analgesia in Total Hip Arthroplasty: A Randomized Controlled 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: PENG block
PENG block with 20ml 0f 0.2% ropivacaine
Drug: Ropivacaine 0.2% Injectable Solution
After spinal anesthesia, the ultrasound-guided PENG block will be performed with 20 ml of 0.2% ropivacaine
Other Names:
  • 0.2% ropivacaine
Sham Comparator: Sham blocks
PENG block with 20ml of 0.9% sodium chloride
Drug: sodium Chloride
After spinal anesthesia, the ultrasound-guided PENG block will be performed with 20ml of 0.9% sodium chloride
Other Names:
  • 0.9% Sodium Chloride Injection

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Systemic Inflammation Response Index (SIRI)
Time Frame: 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

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Systemic Inflammation Response Index (SIRI)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Poznan University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 27, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 4, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 80/26

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Data will become available 6 months after publication of the primary results and will remain available for 5 years.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hip Osteoarthritis

Clinical Trials on Ropivacaine 0.2% Injectable Solution

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings