RecruitingPhase 2NCT06780202

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


Sponsor

Emory University

Enrollment

180 participants

Start Date

Jan 27, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 95 Years

Inclusion Criteria1

  • Emory Orthopedic patients undergoing foot and ankle surgery

Exclusion Criteria8

  • 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).

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Interventions

DRUGmedrol dosepak

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).

DRUGHYDROcodone Oral Tablet

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


Locations(2)

Emory Musculoskeletal Institute, Emory Orthopaedics & Spine Center

Atlanta, Georgia, United States

Emory Sports Medicine Complex and Emory Orthopaedics and Spine Center

Johns Creek, Georgia, United States

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NCT06780202


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