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

NCT06780202 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: STUDY000084542025P009012
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 2

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

Keywords

VAS scale: visual analog scale; Medrol Dosepak

Outcome Measures

Primary Outcomes (3)

• Post operative Nausea

  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

  Baseline (Day 0), 7 days post op

• Post operative pain

  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

  Baseline, 0.25 months, 1.5 months, 3 months, 6 months

• Post operative opioid consumption

  Total number of opioids consumed each day will be captured.

  Baseline (Day 0), 7 days post op

Secondary Outcomes (2)

• Complications due to the Medrol Dosepak

  1.5 months, 3 months, 6 months

• Patient reported outcomes

  Baseline (pre operative assessment), Post operation (6 months)

Study Arms (2)

Medrol

EXPERIMENTAL

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.

Drug: medrol dosepak; Drug: HYDROcodone Oral Tablet

Standard of Care

ACTIVE COMPARATOR

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

Drug: HYDROcodone Oral Tablet

Interventions

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).

Also known as: Methylprednisolone

Medrol

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.

Medrol; Standard of Care

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Emory Orthopedic patients undergoing foot and ankle surgery

You may not qualify if:

• 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).

Sponsors & Collaborators

• Emory University: lead

Study Sites (2)

Emory Musculoskeletal Institute, Emory Orthopaedics & Spine Center

Atlanta, Georgia, 30329, United States

RECRUITING

Emory Sports Medicine Complex and Emory Orthopaedics and Spine Center

Johns Creek, Georgia, 30022, United States

RECRUITING

MeSH Terms

Conditions

Foot Injuries; Disease; Ankle Injuries

Interventions

Methylprednisolone; Hydrocodone

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons

Study Officials

• Rishin Kadakia, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jason Bariteau, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Unblinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: January 17, 2025
• Study Start: January 27, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 9, 2026

Record last verified: 2026-03

Locations

US (2)