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

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT06780202
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Achilles Tendon Injury
  • Ankle Injuries and Disorders
  • Foot Injuries and Disorders

Eligibility Criteria

Sex
ALL
Age
18 Years - 95 Years
Healthy Volunteers
Not accepted

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).
  • 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.

Study Details

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

Key Dates

Start date
Jan 27, 2025
Status verified
Mar 2026
Primary completion
Jun 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
180 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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

Primary Outcome Measure

Post operative Nausea [ Time Frame: Baseline (Day 0), 7 days post op ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Emory Musculoskeletal Institute, Emory Orthopaedics & Spine CenterAtlantaGeorgia30329
Jason Bariteau, MD
[email protected]
404-778-3350
Jason Kadakia, MD (PRINCIPAL_INVESTIGATOR)
Rishin Bariteau, MD (PRINCIPAL_INVESTIGATOR)
Emory Sports Medicine Complex and Emory Orthopaedics and Spine CenterJohns CreekGeorgia30022
Rishin Kadakia, MD
[email protected]
404-778-3350

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Emory Musculoskeletal Institute, Emory Orthopaedics & Spine Center· Atlanta, GAEmory Sports Medicine Complex and Emory Orthopaedics and Spine Center· Johns Creek, GA

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