Assessment of Medrol Dosepak to Reduce Opioid Consumption in Foot and Ankle Surgical Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: medrol dosepak, HYDROcodone Oral Tablet.
- Who it may be relevant to
- Registry conditions: Foot Injuries and Disorders, Ankle Injuries and Disorders, Achilles Tendon Injury. Basic parameters: 18 years — 95 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
Interventions
- Drug 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). - 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.
Primary outcome measures
- 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]
Secondary outcome measures (2)
- Complications due to the Medrol Dosepak [Time frame: 1.5 months, 3 months, 6 months]
- Patient reported outcomes [Time frame: Baseline (pre operative assessment), Post operation (6 months)]
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- Emory Musculoskeletal Institute, Emory Orthopaedics & Spine Center — Atlanta
- Emory Sports Medicine Complex and Emory Orthopaedics and Spine Center — Johns Creek
Identifiers
NCT: NCT06780202 · STUDY00008454 · 2025P009012