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

Not Applicable

Recruiting

• Conditions: Osteoarthritis, Knee; Knee Pain Chronic; Arthropathy of Knee
• Interventions: Drug: NaCl 0.9%; Drug: Dexamethasone 4mg

• Registration Number: NCT07180953
• Lead Sponsor: Poznan University of Medical Sciences

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study Start: 2025-09-01
• Study First Submitted: 2025-09-12
• Study First Submitted QC: 2025-09-12
• Last Update Submitted: 2025-09-12
• Study First Posted: 2025-09-18
• Last Update Posted: 2025-09-18
• Primary Completion: 2025-09-30
• Study Completion: 2025-10-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	NaCl 0.9%	iPACK block with ACB
iv DEX	Dexamethasone 4mg	iPACK block with ACB + iv Dexamethasone
pn DEX	Dexamethasone 4mg	iPACK block with ACB + perineural Dexamethasone

Primary Outcome Measures

Name	Time	Method
Time to first rescue analgesia	Time Frame: 48 hours after surgery	Time to first rescue analgesia

Secondary Outcome Measures

Name	Time	Method
Total opioid consumption	48 hours after surgery	Total opioid consumption (mg) converted to morphine milligram equivalents (MME)
NRS	48 hours after surgery	umeric Rating Scale (NRS), ranging from 0 ("no pain") to 10 ("the worst pain imaginable")
NLR	48 hours after surgery	Neutrophil-to-lymphocyte ratio
PLR	48 hours after surgery	Platelet-to-lymphocyte ratio
Quadriceps muscle strength assessed using medical research council scale [range 0:5]	48 hours after surgery	Quadriceps muscle strength, including knee extension and hip adduction, will be evaluated using the Medical Research Council (MRC) muscle strength grading scale, where higher scores indicate better muscle strength
Nerve damage	48 hours after surgery	Nerve damage assessment will be performed using the following grading scale: N0 - No nerve damage N1 - Minor: sensory paresthesia N2 - Major: complete sensory anesthesia N3 - Complete: complete motor deficit with or without paresthesia N4 - CRPS: Complex Regional Pain Syndrome
glucose	48 hours after surgery	blood glucose level

Trial Locations

Locations (1)

Poznan University of Medical Sciences; 🇵🇱 Poznan, Poland