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Completed

NCT Number: NCT06470139

Dexamethasone for PENG Block in Total Hip Arthroplasty

Effect of adding Dexamethasone to Periarticular Nerve Group Block in Patients undergoing Total Hip Arthroplasty

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Key information

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

Hip 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 0.2% Injectable Solution

Drug

20ml 0.2% Ropivacaine + 2.0ml 0.9% NaCl

Ropivacaine 0.2% Injectable Solution + 4mg Dexamethasone

Drug

20ml 0.2% Ropivacaine + 4mg 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

    Time frame: 12 hours after surgery

    Nerve damage assesent will be performed using scale: N0- no nerve damage; N1- minor - sensory paresthesia; N2- majorcomplete sensory anesthesia; N3- Complete- complete motor defect with or without paraesthesia; N4-CRPS- Complex Regional Pain Syndrome

  13. Nerve damage

    Time frame: 24 hours after surgery

    Nerve damage assesent will be performed using scale: N0- no nerve damage; N1- minor - sensory paresthesia; N2- majorcomplete sensory anesthesia; N3- Complete- complete motor defect with or without paraesthesia; N4-CRPS- Complex Regional Pain Syndrome

  14. Nerve damage

    Time frame: 48 hours after surgery

    Nerve damage assesent will be performed using scale: N0- no nerve damage; N1- minor - sensory paresthesia; N2- majorcomplete sensory anesthesia; N3- Complete- complete motor defect with or without paraesthesia; N4-CRPS- Complex Regional Pain Syndrome

  15. glucose

    Time frame: 24 hours after surgery

    blood glucose levels

  16. glucose

    Time frame: 12 hours after surgery

    blood glucose levels

  17. glucose

    Time frame: 48 hours after surgery

    blood glucose levels

Sponsors and collaborators

Lead sponsor

Poznan University of Medical Sciences

Other

Registry information

Official study title

Pericapsular Nerve Group (PENG) Block with Ropivacaine Vs Ropivacaine and Dexamethasone in Total Hip Arthroplasty: a Randomized Controlled Trial

Important dates

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