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Completed

NCT Number: NCT07180953

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

"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

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Key information

Conditions

Osteoarthritis, Knee Arthritis Arthropathy of Knee Joint Diseases Knee Pain Chronic Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

65 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Poznan University of Medical Sciences

Poznan, 62-701, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Dexamethasone 4mg

Drug

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

Other names: iv Dexamethasone

Primary outcomes

  1. Time to first rescue analgesia

    Time frame: Time Frame: 48 hours after surgery

    Time to first rescue analgesia

Secondary outcomes

  1. Total opioid consumption

    Time frame: 48 hours after surgery

    Total opioid consumption (mg) converted to morphine milligram equivalents (MME)

  2. NRS

    Time frame: 4 hours after surgery

    umeric Rating Scale (NRS), ranging from 0 ("no pain") to 10 ("the worst pain imaginable")

  3. NRS

    Time frame: 8 hours after surgery

    umeric Rating Scale (NRS), ranging from 0 ("no pain") to 10 ("the worst pain imaginable")

  4. NRS

    Time frame: 12 hours after surgery

    umeric Rating Scale (NRS), ranging from 0 ("no pain") to 10 ("the worst pain imaginable")

  5. NRS

    Time frame: 24 hours after surgery

    umeric Rating Scale (NRS), ranging from 0 ("no pain") to 10 ("the worst pain imaginable")

  6. NRS

    Time frame: 48 hours after surgery

    umeric Rating Scale (NRS), ranging from 0 ("no pain") to 10 ("the worst pain imaginable")

  7. NLR

    Time frame: 12 hours after surgery

    Neutrophil-to-lymphocyte ratio

  8. NLR

    Time frame: 24 hours after surgery

    Neutrophil-to-lymphocyte ratio

  9. NLR

    Time frame: 48 hours after surgery

    Neutrophil-to-lymphocyte ratio

  10. PLR

    Time frame: 12 hours after surgery

    Platelet-to-lymphocyte ratio

  11. PLR

    Time frame: 24 hours after surgery

    Platelet-to-lymphocyte ratio

  12. PLR

    Time frame: 48 hours after surgery

    Platelet-to-lymphocyte ratio

  13. Quadriceps muscle strength assessed using medical research council scale [range 0:5]

    Time frame: 4 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

  14. Quadriceps muscle strength assessed using medical research council scale [range 0:5]

    Time frame: 8 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

  15. Quadriceps muscle strength assessed using medical research council scale [range 0:5]

    Time frame: 12 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

  16. Quadriceps muscle strength assessed using medical research council scale [range 0:5]

    Time frame: 24 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

  17. Quadriceps muscle strength assessed using medical research council scale [range 0:5]

    Time frame: 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

  18. Nerve damage

    Time frame: 12 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

  19. Nerve damage

    Time frame: 24 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

  20. Nerve damage

    Time frame: 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

  21. glucose

    Time frame: 12 hours after surgery

    blood glucose level

  22. glucose

    Time frame: 24 hours after surgery

    blood glucose level

  23. glucose

    Time frame: 48 hours after surgery

    blood glucose level

Sponsors and collaborators

Lead sponsor

Poznan University of Medical Sciences

Other

Registry information

Official study title

Route of Dexamethasone Administration in iPACK and ACB for Total Knee Replacement: A Randomized Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 18, 2025
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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