Achilles Tendon Injury, Ankle Injuries and Disorders, Foot Injuries and Disorders
Conditions
Keywords
VAS scale: visual analog scale, Medrol Dosepak
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
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.
Sponsors
Emory University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Unblinded
Eligibility
Sex/Gender
ALL
Age
18 Years to 95 Years
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 unable to give consent, juveniles, pregnant women, prisoners, cognitively impaired and non-English speaking).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post operative Nausea | Baseline (Day 0), 7 days post op | The subjects will report nausea along the visual analog scale (VAS scale), which they will be educated on before surgery. A VAS for nausea is a straight line with one end labeled "no nausea" and the other end labeled "worst nausea imaginable". The patient marks a point on the line to indicate their nausea level. The distance from the "no nausea" end of the line is used to score the nausea intensity |
| Post operative pain | Baseline, 0.25 months, 1.5 months, 3 months, 6 months | The subject will measure pain along the visual analog scale (VAS scale), which they will be educated on before surgery. A VAS for pain is a straight line with one end labeled "no pain" and the other end labeled "worst pain imaginable". The patient marks a point on the line to indicate their pain level. The distance from the "no pain" end of the line is used to score the pain intensity |
| Post operative opioid consumption | Baseline (Day 0), 7 days post op | Total number of opioids consumed each day will be captured. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complications due to the Medrol Dosepak | 1.5 months, 3 months, 6 months | Complications will be monitored via radiographs and clinical analyses at post-operative appointments for impaired wound-healing and infection |
| Patient reported outcomes | Baseline (pre operative assessment), Post operation (6 months) | Patient-reported outcomes will be measured along the 12-item Short Form Health Survey which measures the impact of their current health on everyday life, the Patient-Reported Outcomes Measurement Information System (PROMIS) which measures physical, mental, and social health and the VAS scale, which measures pain at rest |
Countries
United States
Contacts
CONTACTJason Bariteau, MD
PRINCIPAL_INVESTIGATORRishin Kadakia, MD
Emory University
Outcome results
None listed