Assessment of Medrol Dosepak to Reduce Opioid Consumption in Foot and Ankle Surgical Patients
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-95
SponsorEmory University
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Concurrent or significant injuries to other bones or organs
Local infections
History of alcohol or medical abuse, including prior opioid abuse
Smoking
Trial design
Design model
Parallel
Treatments tested in this trial
medrol dosepak
DrugMethylprednisolone 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
DrugThis study will utilize a prescription of 20 pills of hydrocodone, 5mg each, to be taken as needed for pain, 1 every 6 hours.
Treatment groups
180 Participants
are divided into 2 treatment groupsGroup A: MedrolExperimental treatment 2 interventions
Group B: Standard of CareActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Post operative Nausea
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
Time frame
Baseline (Day 0), 7 days post op2
Post operative pain
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
Time frame
Baseline, 0.25 months, 1.5 months, 3 months, 6 months3
Post operative opioid consumption
Total number of opioids consumed each day will be captured.
Time frame
Baseline (Day 0), 7 days post opSecondary outcomes
1
Complications due to the Medrol Dosepak
Complications will be monitored via radiographs and clinical analyses at post-operative appointments for impaired wound-healing and infection
Time frame
1.5 months, 3 months, 6 months2
Patient reported outcomes
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
Time frame
Baseline (pre operative assessment), Post operation (6 months)Sponsors and contacts
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Source ClinicalTrials.gov