Assessment of Medrol Dosepak to Reduce Opioid Consumption in Foot and Ankle Surgical Patients
Emory University
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
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.…
Eligibility
- Age range
- 18–95 years
- Sex
- All
- Healthy volunteers
- No
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 un…
Interventions
- Drugmedrol 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).
- DrugHYDROcodone 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.
Locations (2)
- Emory Musculoskeletal Institute, Emory Orthopaedics & Spine CenterAtlanta, Georgia
- Emory Sports Medicine Complex and Emory Orthopaedics and Spine CenterJohns Creek, Georgia