Impact of Dexamethasone Route on Pain and Inflammation in iPACK With ACB for Knee Arthroplasty

NCT07180953 | Recruiting Phase 4

• 1 other identifier: 02/20025
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

"The Effect of Dexamethasone Administration Route on Pain and Inflammatory Response in iPACK With ACB for Total Knee Arthroplasty" - written in plain language according to ClinicalTrials.gov standards: The goal of this clinical trial is to learn how the route of dexamethasone administration (either through the vein or nerve block) affects pain and inflammation in people having total knee replacement surgery. All participants will receive two types of nerve blocks before surgery: an iPACK block and an adductor canal block (ACB), which help control pain after the operation. The main questions the study aims to answer are: Does injecting dexamethasone into the nerve block reduce pain more effectively than giving it by vein? Which method leads to a lower inflammatory response after surgery? Researchers will compare the two groups to see which route offers better pain relief and less swelling after knee surgery. Participants will: Be randomly assigned to receive dexamethasone either in the nerve block or by IV Receive standard care for total knee replacement Rate their pain and have blood tests after surgery to measure inflammation

Conditions

Osteoarthritis, Knee; Knee Pain Chronic; Arthropathy of Knee

Outcome Measures

Primary Outcomes (1)

• Time to first rescue analgesia

  Time to first rescue analgesia

  Time Frame: 48 hours after surgery

Secondary Outcomes (23)

• Total opioid consumption

  48 hours after surgery

• NRS

  4 hours after surgery

• NRS

  8 hours after surgery

• NRS

  12 hours after surgery

• NRS

  24 hours after surgery

Study Arms (3)

Control

PLACEBO COMPARATOR

iPACK block with ACB

Drug: NaCl 0.9%

iv DEX

ACTIVE COMPARATOR

iPACK block with ACB + iv Dexamethasone

Drug: Dexamethasone 4mg

pn DEX

ACTIVE COMPARATOR

iPACK block with ACB + perineural Dexamethasone

Drug: Dexamethasone 4mg

Interventions

NaCl 0.9% DRUG

iPACK block with Adductor Canal Block (2 x 20ml 0.2% ropivacaine + 1ml 0.9% NaCl) + 2ml 0.9% NaCl iv

Control

Dexamethasone 4mg DRUG

iPACK block with Adductor Canal Block (2 x 20ml 0.2% ropivacaine + 1ml 0.9% NaCl) + 4mg Dexamethasone iv

Also known as: iv Dexamethasone

iv DEX

Eligibility Criteria

• Age: 65 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• patients scheduled for total knee arthroplasty
• patients aged \>65 and \<100 years
• patients can provide informed consent
• patients can reliably report symptoms to the research team

You may not qualify if:

• inability to provide first-party consent due to cognitive impairment or a
• language barrier
• infection at the site of the regional block,
• coagulation disorders,
• immunodeficiency,
• American Society of Anesthesiologists (ASA) physical status of IV or higher,
• history of regular steroid medication.

Sponsors & Collaborators

• Poznan University of Medical Sciences: lead

Study Sites (1)

Poznan University of Medical Sciences

Poznan, 62-701, Poland

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Sodium Chloride; Dexamethasone

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Central Study Contacts

Malgorzata Reysner, MD PhD

CONTACT

+48618738303; mreysner@ump.edu.pl

Grzegorz Kowalski, MD PhD

CONTACT

+48618738313

Study Design

• Study Type: interventional
• Phase: phase 4
• 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: September 12, 2025
• First Posted: September 18, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: February 2, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

PL (1)