Clinical trial NCT06780202: Assessment of Medrol Dosepak to Reduce Opioid Consumption in Foot and Ankle Surgical Patients
Official title: Assessment of Medrol Dosepak to Reduce Opioid Consumption in Foot and Ankle Surgical Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Foot Injuries and Disorders
Ankle Injuries and Disorders
Achilles Tendon Injury
Keywords: VAS scale: visual analog scale
Medrol Dosepak
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2025-01-17
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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).

Primary outcomes:
measure: Post operative Nausea
timeFrame: Baseline (Day 0), 7 days post op
measure: Post operative pain
timeFrame: Baseline, 0.25 months, 1.5 months, 3 months, 6 months
measure: Post operative opioid consumption
timeFrame: Baseline (Day 0), 7 days post op
Secondary outcomes:
measure: Complications due to the Medrol Dosepak
timeFrame: 1.5 months, 3 months, 6 months
measure: Patient reported outcomes
timeFrame: Baseline (pre operative assessment), Post operation (6 months)
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory Musculoskeletal Institute, Emory Orthopaedics & Spine Center
state: Georgia
city: Johns Creek
country: United States
facility: Emory Sports Medicine Complex and Emory Orthopaedics and Spine Center
state: Georgia
Study officials:
affiliation: Emory University
name: Rishin Kadakia, MD
role: PRINCIPAL_INVESTIGATOR
References: