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NCT Number: NCT06789328

The Effect of Dexamethasone Administration Route on Pain and Inflammatory Response in PENG Block for Total Hip Arthroplasty

This study aims to evaluate the effect of the dexamethasone administration route (intravenous vs. perineural) on postoperative pain, inflammatory response, and clinical outcomes in patients undergoing total hip arthroplasty (THA) with a pericapsular nerve group (PENG) block. The primary outcome is the intensity of postoperative pain measured using the numerical rating scale (NRS) at rest and during movement. Secondary outcomes include the inflammatory response assessed by neutrophil-to-lymphocyte ratio (NLR) and platelet-to-lymphocyte ratio (PLR), opioid consumption, and patient satisfaction. The findings from this study may contribute to optimizing anesthesia protocols and improving postoperative recovery in patients undergoing THA.

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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, 60-701, Poland

About this study

Total hip arthroplasty (THA) is a common orthopedic procedure associated with significant postoperative pain and inflammation, which can impact recovery and long-term outcomes. Regional anesthesia techniques, such as the pericapsular nerve group (PENG) block, have become increasingly popular for pain management in THA due to their ability to provide effective analgesia while preserving motor function.

Dexamethasone is frequently used as an adjuvant in regional anesthesia to prolong the duration of analgesia and reduce inflammation. However, there is limited evidence comparing the efficacy of different administration routes of dexamethasone (intravenous vs. perineural) in the context of PENG block. Additionally, understanding the impact of dexamethasone on postoperative pain, inflammatory markers, and overall patient recovery is crucial for optimizing clinical protocols.

This study is a prospective, randomized, double-blinded trial involving patients undergoing elective THA. Participants will be randomly assigned to two groups: the IV dexamethasone group or the perineural dexamethasone group. Both groups will receive standardized general anesthesia and PENG block with local anesthetic. Postoperative pain will be assessed using the NRS at various time intervals (e.g., 6, 12, 24, and 48 hours postoperatively) at rest and during movement. NLR and PLR will measure the inflammatory response from blood samples taken preoperatively and 24 hours postoperatively.

The primary outcome is time first to request rescue analgesia. Secondary outcomes include cumulative opioid consumption, length of hospital stay, and patient satisfaction. Safety and potential complications, such as local anesthetic systemic toxicity (LAST), will be closely monitored.

The results of this study may provide valuable insights into the optimal use of dexamethasone as an adjuvant in regional anesthesia for THA, potentially improving pain management, reducing opioid use, and enhancing postoperative recovery.

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
  • 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

perineural Dexamethasone 4mg

Drug

PENG block with 20ml 0.2% ropivacaine + 4mg perineural Dexamethasone

intravenous Dexamethsone 4mg

Drug

PENG block with 20ml 0.2% ropivacaine + 4mg intravenous Dexamethasone

Primary outcomes

  1. Time to first rescue opioid analgesia

    Time frame: 48 hours after surgery

    Time to first rescue opioid 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

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

  3. NRS

    Time frame: 8 hours after surgery

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

  4. NRS

    Time frame: 12 hours after surgery

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

  5. NRS

    Time frame: 24 hours after surgery

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

  6. NRS

    Time frame: 48 hours after surgery

    Numeric 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

    uadriceps muscle strength, including knee extension and hip adduction, will be evaluated using the Medical Research Council (MRC) muscle strength grading scale.

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

    Time frame: 8 hours after surgery

    uadriceps muscle strength, including knee extension and hip adduction, will be evaluated using the Medical Research Council (MRC) muscle strength grading scale.

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

    Time frame: 12 hours after surgery

    uadriceps muscle strength, including knee extension and hip adduction, will be evaluated using the Medical Research Council (MRC) muscle strength grading scale.

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

    Time frame: 24 hours after surgery

    uadriceps muscle strength, including knee extension and hip adduction, will be evaluated using the Medical Research Council (MRC) muscle strength grading scale.

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

    Time frame: 48 hours after surgery

    uadriceps muscle strength, including knee extension and hip adduction, will be evaluated using the Medical Research Council (MRC) muscle strength grading scale.

  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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 23, 2025
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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