NCT07449442

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Mar 2026

Shorter than P25 for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 27, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 4, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Completed
Last Updated

May 22, 2026

Status Verified

April 1, 2026

Enrollment Period

3 months

First QC Date

February 27, 2026

Last Update Submit

May 20, 2026

Conditions

Knee Osteoarthritis

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

PLACEBO COMPARATOR

iPACK block with 20ml of 0.9% sodium chloride and ACB with 20ml of 0.9% sodium chloride

Drug: sodium Chloride

iPACK block with ACB

ACTIVE COMPARATOR

iPACK block with 20ml of 0.2% ropivacaine and ACB with 20ml of 0.2% ropivacaine

Drug: Ropivacaine Hydrocloride

Interventions

sodium ChlorideDRUG

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

Also known as: 0.9% NaCl
Sham blocks
Ropivacaine HydroclorideDRUG

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

Also known as: 0.2% ropivacaine
iPACK block with ACB

Eligibility Criteria

Age65 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

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

Study Sites (1)

Poznan University of Medical Sciences

Poznan, 62-701, Poland

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Sodium ChlorideSaline SolutionRopivacaine

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Malgorzata Reysner, MD PhD

    Poznań University of Medical Sciences

    STUDY CHAIR

Central Study Contacts

Malgorzata Reysner, MD PhD

CONTACT

+48 501 056 924mreysner@ump.edu.pl

Malgorzata Reysner, MD PhD

CONTACT

+48 61 83 10 122mreysner@ump.edu.pl

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

March 1, 2026

Primary Completion

May 31, 2026

Study Completion

June 30, 2026

Last Updated

May 22, 2026

Record last verified: 2026-04

Locations

PL(1)