Actively Recruiting

Phase 2
Age: 18Years - 95Years
All Genders
ID06780202

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

Led by Emory University · Updated on 2026-03-09

180

Participants Needed

2

Research Sites

26 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of a 6-day low-dose oral methylprednisolone course, known as Medrol Dosepak, on pain, nausea, and opioid use in patients undergoing foot and ankle surgeries. The study also aims to monitor any complications and patient-reported outcomes following surgery. This research addresses the opioid epidemic by exploring ways to reduce opioid exposure through multimodal pain management, focusing on forefoot, ankle, and Achilles surgeries.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 95Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Emory Orthopedic patients undergoing foot and ankle surgery
Not Eligible

You will not qualify if you...

  • 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
  • Vulnerable populations including those unable to give consent, juveniles, pregnant women, prisoners, cognitively impaired, and non-English speaking individuals

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 6 days for Medrol Dosepak with pain and opioid use recorded for 7 days post surgery

Participants undergo foot and ankle surgery and receive either a 6-day low-dose oral Medrol Dosepak or standard pain management. They record pain, nausea, and opioid use starting the day of surgery and continuing for 7 days in a pain journal.

1 surgery day visit and daily self-reporting for 7 days post surgery

Follow-up

Duration - Up to 6 months

Participants attend a post-operative appointment approximately 2 weeks after surgery to review pain journals and evaluate for complications. Additional assessments occur at 1.5, 3, and 6 months to monitor complications and patient-reported outcomes.

1 visit around 2 weeks post surgery and additional visits for assessments at 1.5, 3, and 6 months

Trial Site Locations

Total: 2 locations

1

Emory Musculoskeletal Institute, Emory Orthopaedics & Spine Center

Atlanta, Georgia, United States, 30329

Actively Recruiting

2

Emory Sports Medicine Complex and Emory Orthopaedics and Spine Center

Johns Creek, Georgia, United States, 30022

Actively Recruiting

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Research Team

J

Jason Bariteau, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Frequently Asked Questions

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