ClinicalTrials.gg
CompletedNCT07449403Updated Nov 6, 2026

SIRI Levels Following PENG Block in Hip Arthroplasty

An interventional study of sodium Chloride and Ropivacaine 0.2% Injectable Solution in Hip Osteoarthritis, sponsored by Poznan University of Medical Sciences. Completed at 1 site in Poland. Open to participants aged 65 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-11-06.

Sponsored by Poznan University of Medical Sciences · Not applicable, Interventional, and Treatment

Updated Nov 6, 2026Now CompletedPrimary completion moved+3 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
65 Years to 100 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 13 studies testing ropivacaine in Osteoarthritis, Hip — 3 open to participants now, 3 under way, none of them phase 3. Ropivacaine · Osteoarthritis, Hip.

Enrollment
9th of 13
60 · median 90
Started
2026
with 2 others
No phase
3 of 13
1 open now
Registered
11th of 13
by date
Lead sponsor
8 of 13
Poznan University of Medical Sciences

Among the 13 studies testing ropivacaine in Osteoarthritis, Hip, this one is the 9th largest by enrollment, is one of 3 that started in 2026, is one of 3 with no phase, and was the 11th registered.

By phase

13 studies; the count open now beside each. This study's row is marked.

Phase 410 · 2 open
No phasethis study3 · 1 open

By the year they started

First in 2014; this study’s year is marked. 3 started in 2026.

Tested beside ropivacaine

Size and results

Median enrollment 90 across the 13 interventional studies. Of the 8 that completed or were terminated, 1 (13%) have results posted.

Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 13 studies testing ropivacaine in Osteoarthritis, Hip, or all of them as a file.
02

Study summary

This randomized controlled trial evaluates the effect of ultrasound-guided Pericapsular Nerve Group (PENG) block on the Systemic Inflammation Response Index (SIRI) in elderly patients undergoing total hip arthroplasty under spinal anesthesia. SIRI, calculated as neutrophil count × monocyte count / lymphocyte count, is used as a composite marker of perioperative inflammatory response. The study investigates whether PENG block attenuates the systemic inflammatory reaction to surgical trauma compared to sham block. The study investigates whether PENG block attenuates the systemic inflammatory reaction to surgical trauma compared to sham block.

Read the 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 Inflammation Response Index (SIRI) is calculated as neutrophil count × monocyte count / lymphocyte count. It incorporates neutrophils and monocytes in relation to lymphocytes as a composite marker of systemic inflammation. This study evaluates whether PENG block influences postoperative SIRI in patients undergoing total hip arthroplasty.

The primary objective of this study is to compare SIRI at 12 hours after surgery between the PENG block and sham block groups in elderly patients undergoing total hip arthroplasty under spinal anesthesia.

Peripheral venous blood samples will be collected preoperatively and at 12, 24, and 48 hours after surgery. The primary endpoint is SIRI at 12 hours after surgery.

This study aims to determine whether motor-sparing regional anesthesia may modulate systemic inflammatory response beyond analgesic effects, potentially contributing to improved perioperative outcomes.

03

Conditions studied

  • Hip Osteoarthritis

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04

Who can participate

Ages eligible
65 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients with I-III
  • Aged 65-100 years
  • Who will be scheduled for hip arthroplasty under spinal anesthesia

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • Sham comparator
    Sham blocks

    PENG block with 20ml of 0.9% sodium chloride

    Drug: sodium Chloride

  • Active comparator
    PENG block

    PENG block with 20ml 0f 0.2% ropivacaine

    Drug: Ropivacaine 0.2% Injectable Solution

Interventions

  • Drugsodium Chloride

    After spinal anesthesia, the ultrasound-guided PENG block will be performed with 20ml of 0.9% sodium chloride

    Also known as: 0.9% Sodium Chloride Injection

  • After spinal anesthesia, the ultrasound-guided PENG block will be performed with 20 ml of 0.2% ropivacaine

    Also known as: 0.2% ropivacaine

06

What researchers measure

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 surgery

Secondary 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 surgery

  2. 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 surgery

  3. 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 surgery

  4. 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 surgery

  5. 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: 48 hours after surgery

  6. Platelet Mass Index (PMI)

    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.

    Time frame: 12 hours after surgery

  7. Platelet Mass Index (PMI)

    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.

    Time frame: 24 hours after surgery

  8. Platelet Mass Index (PMI)

    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.

    Time frame: 48 hours after surgery

  9. C-reactive Protein (CRP) Concentration

    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.

    Time frame: 12 hours after surgery

  10. C-reactive Protein (CRP) Concentration

    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.

    Time frame: 24 hours after surgery

  11. C-reactive Protein (CRP) Concentration

    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.

    Time frame: 48 hours after surgery

  12. Postoperative Pain Intensity (NRS)

    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.

    Time frame: 4 hours after surgery

  13. Postoperative Pain Intensity (NRS)

    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.

    Time frame: 8 hours after surgery

  14. Postoperative Pain Intensity (NRS)

    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.

    Time frame: 12 hours after surgery

  15. Postoperative Pain Intensity (NRS)

    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.

    Time frame: 24 hours after surgery

  16. Postoperative Pain Intensity (NRS)

    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.

    Time frame: 48 hours after surgery

  17. Opioid Consumption

    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 frame: 48 hours after surgery

  18. Time to First Rescue Analgesia

    Time from completion of surgery to first administration of rescue opioid analgesia. Measured in minutes. Shorter time indicates earlier breakthrough pain.

    Time frame: 48 hours after surgery

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Yes — 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.

Supporting information: Study protocol, Statistical analysis plan, 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.

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Status
Recruiting→Completed
changed Nov 6, 2026
Primary completion
Sep 1, 2026→Sep 30, 2026 (actual)
Nov 6, 2026
Study completion
Sep 30, 2026→Oct 2, 2026 (actual)
Nov 6, 2026
Title
SIISIRI Levels Following PENG Block in Hip Arthroplasty
Nov 6, 2026
Show all 1 update
  1. Nov 6, 2026
    Recruiting→Completed
    Primary completion Sep 1, 2026→Sep 30, 2026 (now actual)
    Study completion Sep 30, 2026→Oct 2, 2026 (now actual)
    Title SIISIRI Levels Following PENG Block in Hip Arthroplasty
    + 4 other changes: verification date, description, site details and contact details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07449403
Responsible party
Sponsor
First posted
Mar 4, 2026
Start date
Mar 1, 2026
Primary completion
Sep 30, 2026
Completion
Oct 2, 2026
Last update
Nov 6, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Ropivacaine

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