Assessment of Medrol Dosepak to Reduce Opioid Consumption in Foot and Ankle Surgical Patients

Last updated: February 24, 2025
Sponsor: Emory University
Overall Status: Active - Recruiting

Phase

2

Condition

Tendon Injuries

Treatment

HYDROcodone Oral Tablet

medrol dosepak

Clinical Study ID

NCT06780202
STUDY00008454
  • Ages 18-95
  • All Genders

Study Summary

This clinical trial aims to determine the effects of a 6-day low-dose methylprednisolone course on pain, nausea, and total opioid consumption in patients undergoing foot and ankle surgeries.

The secondary objective of the study is to determine and monitor the effects of the course on complications following surgery and patient-reported outcomes

Eligibility Criteria

Inclusion

Inclusion Criteria:

-Emory Orthopedic patients undergoing foot and ankle surgery

Exclusion

Exclusion Criteria:

  • Concurrent or significant injuries to other bones or organs

  • Local infections

  • History of alcohol or medical abuse, including prior opioid abuse

  • Smoking

  • History of severe heart disease, renal failure, liver dysfunction, active pepticulcer disease, diabetes, rheumatoid arthritis, neurological or psychiatric diseasesthat could influence pain perception

  • Pre-existing immune suppression

  • Those deemed possibly non-compliant by the study team and,

  • All vulnerable populations (those unable to give consent, juveniles, pregnant women,prisoners, cognitively impaired and non-English speaking).

Study Design

Total Participants: 180
Treatment Group(s): 2
Primary Treatment: HYDROcodone Oral Tablet
Phase: 2
Study Start date:
January 27, 2025
Estimated Completion Date:
December 31, 2026

Study Description

The opioid epidemic continues to create a lasting impact on society, leading researchers to focus on ways to decrease opioid prescription rates and subsequently, opioid consumption. Opioid-naïve patients undergoing minor to major surgeries have been shown statistically to be largely affected.1 This includes significant numbers resulting from forefoot surgery specifically with around 6.2% of the mentioned population being at risk for new persistent opioid use.

This has provoked researchers to seek a new route that decreases exposure to opioid use through proposals for multimodal pain regimes.

A recent addition to some of these proposed treatments has been a 6-day low-dose oral methylprednisolone taper beginning on the day of surgery. This has been tested with "terrible triad" elbow injuries, distal radius fractures, and total shoulder arthroplasties with promising results showing decreased consumption of the as-needed opioid prescription. Furthermore, the results of these studies show a significant decrease in pain and increased range of motion following surgery. This is likely due to the anti-inflammatory functioning of glucocorticoids, without inhibiting the healing process.

Based upon the findings stated above, the proposed research will attempt to apply this new pain regime to foot and ankle surgeries, specifically forefoot, ankle, and Achilles surgeries, to take another step towards bettering perioperative care with opioid-free treatment

Connect with a study center

  • Emory Musculoskeletal Institute, Emory Orthopaedics & Spine Center

    Atlanta, Georgia 30329
    United States

    Active - Recruiting

  • Emory Sports Medicine Complex and Emory Orthopaedics and Spine Center

    Johns Creek, Georgia 30022
    United States

    Active - Recruiting

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