Recruiting
Phase 2

Medrol

Sponsor:

Emory University

Code:

NCT06780202

Conditions

Foot Injuries and Disorders

Ankle Injuries and Disorders

Achilles Tendon Injury

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

medrol dosepak

HYDROcodone Oral Tablet

Study Details

Brief 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

Conditions

Foot Injuries and Disorders

Ankle Injuries and Disorders

Achilles Tendon Injury

Study ID

NCT06780202

Start date

Jan 27, 2025

Status verified date

Mar, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

180 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Medrol

The group will be given Medrol Dosepak in a tapered, low-dose manner, orally once a day.

Subjects will be sent home with a pain journal where they will record their pain and nausea 3 times daily starting the day of surgery and the following 7 days along with their daily hydrocodone consumption. These journals will be collected at their 2-week post-op appointment which is scheduled ± 1 week. In this appointment, subjects will also be evaluated for complications.

active comparator: Standard of Care

Each subject will receive the standard pain regime of both surgeons. This includes a nerve block before surgery for pain prevention. While in surgery, the subject will receive 10 mg of dexamethasone intravenously. Post-surgery, each subject will be instructed to take vitamin C for nerve pain and vitamin D for bone healing. They will also be provided with a prescription of aspirin for deep vein thrombosis (DVT) prophylaxis, ondansetron (Zofran) for nausea, and Colace for constipation relief. Both groups will receive a prescription of 20 5 mg hydrocodone pills to be taken as needed for pain, 1 every 6 hours

Subjects will be sent home with a pain journal where they will record their pain and nausea 3 times starting the day of surgery and the following 7 days along with their daily hydrocodone consumption. Journals will be collected at their 2-week post-op appointment which is scheduled ± 1 week. Subjects will also be evaluated for complications

Interventions

medrol 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).

HYDROcodone 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.

Primary outcome measure

  • Post operative Nausea [ Time Frame: Baseline (Day 0), 7 days post op ]
  • Post operative pain [ Time Frame: Baseline, 0.25 months, 1.5 months, 3 months, 6 months ]
  • Post operative opioid consumption [ Time Frame: Baseline (Day 0), 7 days post op ]

Central Contacts and Locations

Central contacts

Jason Bariteau, MD

404-778-3350jason.bariteau@emory.edu

Locations

Emory Musculoskeletal Institute, Emory Orthopaedics & Spine Center

Recruiting

Atlanta, Georgia, United States, 30329

Contacts

Jason Bariteau, MD

404-778-3350jason.bariteau@emory.edu

Principal Investigator:

Jason Kadakia, MD

Emory Sports Medicine Complex and Emory Orthopaedics and Spine Center

Recruiting

Johns Creek, Georgia, United States, 30022

Contacts

Rishin Kadakia, MD

404-778-3350rishin.j.kadakia@emory.edu

More Information

Sponsor

Emory University

Last update posted

Mar 9, 2026

Last verified

Mar, 2026

Keywords

  • VAS scale: visual analog scale
  • Medrol Dosepak

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Emory University on 2026-03-09.