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NCT Number: NCT06780202

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

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

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Key information

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Emory Musculoskeletal Institute, Emory Orthopaedics & Spine Center, Atlanta, Georgia, United States

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About this study

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

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

-Emory Orthopedic patients undergoing foot and ankle surgery

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 peptic ulcer disease, diabetes, rheumatoid arthritis, neurological or psychiatric diseases that 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).

Treatment and study plan

medrol dosepak

Drug

Methylprednisolone is a corticosteroid with anti-inflammatory properties and immune suppression.

This study will utilize a 6-day Medrol Dosepak: a tapered low-dose corticosteroid course taken orally once a day. This includes 6 tablets on day 1 (24 mg), 5 tablets on day 2 (20 mg), 4 tablets on day 3 (16 mg), 3 tablets on day 4 (12 mg), 2 tablets on day 5 (8 mg) and 1 tablet on day 6 (4 mg).

Other names: Methylprednisolone

HYDROcodone Oral Tablet

Drug

This study will utilize a prescription of 20 pills of hydrocodone, 5mg each, to be taken as needed for pain, 1 every 6 hours.

Primary outcomes

  1. Post operative Nausea

    Time frame: Baseline (Day 0), 7 days post op

    The subjects will report nausea along the visual analog scale (VAS scale), which they will be educated on before surgery.

    A VAS for nausea is a straight line with one end labeled "no nausea" and the other end labeled "worst nausea imaginable". The patient marks a point on the line to indicate their nausea level. The distance from the "no nausea" end of the line is used to score the nausea intensity

  2. Post operative pain

    Time frame: Baseline, 0.25 months, 1.5 months, 3 months, 6 months

    The subject will measure pain along the visual analog scale (VAS scale), which they will be educated on before surgery.

    A VAS for pain is a straight line with one end labeled "no pain" and the other end labeled "worst pain imaginable". The patient marks a point on the line to indicate their pain level. The distance from the "no pain" end of the line is used to score the pain intensity

  3. Post operative opioid consumption

    Time frame: Baseline (Day 0), 7 days post op

    Total number of opioids consumed each day will be captured.

Secondary outcomes

  1. Complications due to the Medrol Dosepak

    Time frame: 1.5 months, 3 months, 6 months

    Complications will be monitored via radiographs and clinical analyses at post-operative appointments for impaired wound-healing and infection

  2. Patient reported outcomes

    Time frame: Baseline (pre operative assessment), Post operation (6 months)

    Patient-reported outcomes will be measured along the 12-item Short Form Health Survey which measures the impact of their current health on everyday life, the Patient-Reported Outcomes Measurement Information System (PROMIS) which measures physical, mental, and social health and the VAS scale, which measures pain at rest

Study contacts

Contact information is provided by the study sponsor or research team.

Jason Bariteau, MD

CONTACT

[email protected]

404-778-3350

Sponsors and collaborators

Lead sponsor

Emory University

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 17, 2025
Registry last updated
Mar 9, 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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