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

NCT ID: NCT06780202

Last Updated: 2025-02-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-27
• Study Completion Date: 2026-12-31

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

Detailed Description

The opioid epidemic continues to create a lasting impact on society, leading researchers to focus on ways to decrease opioid prescription rates and subsequently, opioid consumption. Opioid-naïve patients undergoing minor to major surgeries have been shown statistically to be largely affected.1 This includes significant numbers resulting from forefoot surgery specifically with around 6.2% of the mentioned population being at risk for new persistent opioid use.

This has provoked researchers to seek a new route that decreases exposure to opioid use through proposals for multimodal pain regimes.

A recent addition to some of these proposed treatments has been a 6-day low-dose oral methylprednisolone taper beginning on the day of surgery. This has been tested with "terrible triad" elbow injuries, distal radius fractures, and total shoulder arthroplasties with promising results showing decreased consumption of the as-needed opioid prescription. Furthermore, the results of these studies show a significant decrease in pain and increased range of motion following surgery. This is likely due to the anti-inflammatory functioning of glucocorticoids, without inhibiting the healing process.

Based upon the findings stated above, the proposed research will attempt to apply this new pain regime to foot and ankle surgeries, specifically forefoot, ankle, and Achilles surgeries, to take another step towards bettering perioperative care with opioid-free treatment

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

medrol dosepak

Intervention Type: 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

Intervention Type: 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.

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

Group Type: ACTIVE_COMPARATOR

HYDROcodone Oral Tablet

Intervention Type: 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.

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).

Intervention Type: DRUG

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.

Intervention Type: DRUG

Other Intervention Names

Methylprednisolone

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Jason Bariteau

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rishin Kadakia, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Emory Musculoskeletal Institute, Emory Orthopaedics & Spine Center

Atlanta, Georgia, United States

Site Status: RECRUITING

Emory Sports Medicine Complex and Emory Orthopaedics and Spine Center

Johns Creek, Georgia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jason Bariteau, MD

Role: CONTACT

jason.bariteau@emory.edu

404-778-3350

Facility Contacts

Jason Bariteau, MD

Role: primary

jason.bariteau@emory.edu

404-778-3350

Rishin Kadakia, MD

Role: primary

rishin.j.kadakia@emory.edu

404-778-3350

Other Identifiers

STUDY00008454

Identifier Type: -

Identifier Source: org_study_id