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Completed

NCT Number: NCT06470204

Dexamethasone for iPACK Block With ACB in Total Knee Arthroplasty

Effect of adding Dexamethasone to Infiltration between the Popliteal Artery and Capsule of the Knee Block with ACB in Patients undergoing Total Knee Arthroplasty

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Knee Arthritis Knee Pain Chronic Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee 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, Poznań, 61-701, Poland

About this study

Knee arthroplasty is one of the most common orthopaedic procedures, especially in elderly patients, due to the deformation of joints. Patients may complain of severe pain due to surgical trauma and prostheses. Regional anaesthesia methods may be performed to reduce the inflammatory response, opioid consumption, and opioid-related side effects.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • inability to provide first-party consent due to cognitive impairment or a language barrier

Treatment and study plan

Ropivacaine

Drug

Ultrasound-guided iPACK block + ACB - 2 x (20ml 0,2% ropivacaine + 2ml 0.9% NaCl)

Ropivacaine+Dexamethasone

Drug

Ultrasound-guided iPACK block + ACB - 2 x (20ml 0,2% ropivacaine + 2mg Dexamethasone)

Primary outcomes

  1. Time to first rescue opioid analgesia

    Time frame: 48 hours after surgery

    Time after surgery when the patient needs opiate for the first time

Secondary outcomes

  1. Total Opioid Consumption

    Time frame: 48 hours after surgery

    Total opiate consumption after surgery

  2. Numerical Rating Scale [range 0:10]

    Time frame: 4 hours after surgery

    Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt)

  3. Numerical Rating Scale [range 0:10]

    Time frame: 8 hours after surgery

    Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt)

  4. Numerical Rating Scale [range 0:10]

    Time frame: 12 hours after surgery

    Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt)

  5. Numerical Rating Scale [range 0:10]

    Time frame: 24 hours after surgery

    Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt)

  6. Numerical Rating Scale [range 0:10]

    Time frame: 48 hours after surgery

    Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt)

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

    Time frame: 4 hours after surgery

    Quadriceps muscle strength (knee extension and hip adduction) will be evaluated according to the medical research council muscle strength rating

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

    Time frame: 8 hours after surgery

    Quadriceps muscle strength (knee extension and hip adduction) will be evaluated according to the medical research council muscle strength rating

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

    Time frame: 12 hours after surgery

    Quadriceps muscle strength (knee extension and hip adduction) will be evaluated according to the medical research council muscle strength rating

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

    Time frame: 24 hours after surgery

    Quadriceps muscle strength (knee extension and hip adduction) will be evaluated according to the medical research council muscle strength rating

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

    Time frame: 48 hours after surgery

    Quadriceps muscle strength (knee extension and hip adduction) will be evaluated according to the medical research council muscle strength rating

  12. Nerve damage [range 0-4]

    Time frame: 12 hours after surgery

    Nerve damage assesment will be performed using the nerve damage score (N0- no nerve damage; N1- minor - sensory paresthesia; N2- major -complete sensory anesthesia; N3- Complete- complete motor defect with or without paraesthesia; N4-CRPS- Complex Regional Pain Syndrome)

  13. Nerve damage [range 0-4]

    Time frame: 24 hours after surgery

    Nerve damage assesment will be performed using the nerve damage score (N0- no nerve damage; N1- minor - sensory paresthesia; N2- major -complete sensory anesthesia; N3- Complete- complete motor defect with or without paraesthesia; N4-CRPS- Complex Regional Pain Syndrome)

  14. Nerve damage [range 0-4]

    Time frame: 48 hours after surgery

    Nerve damage assesment will be performed using the nerve damage score (N0- no nerve damage; N1- minor - sensory paresthesia; N2- major -complete sensory anesthesia; N3- Complete- complete motor defect with or without paraesthesia; N4-CRPS- Complex Regional Pain Syndrome)

  15. glucose

    Time frame: 12 hours after surgery

    blood glucose level

  16. glucose

    Time frame: 24 hours after surgery

    blood glucose level

  17. 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

Infiltration Between the Popliteal Artery and Capsule of the Knee Block With Adductor Canal Block With Ropivacaine vs Ropivacaine and Dexamethasone in Total Knee Arthroplasty: A Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 24, 2024
Registry last updated
Jul 23, 2025

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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