Foot Injuries and DisordersPhase 2NCT06780202
Assessment of Medrol Dosepak to Reduce Opioid Consumption in Foot and Ankle Surgical Patients
A Phase 2 study testing medrol dosepak and HYDROcodone Oral Tablet in people with Foot Injuries and Disorders and Ankle Injuries and Disorders, run by Emory University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Foot Injuries and Disorders, Ankle Injuries and Disorders, Achilles Tendon Injury
- What is being tested?
- medrol dosepak and HYDROcodone Oral Tablet
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 Jan 2025to Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -Emory Orthopedic patients undergoing foot and ankle surgery
Who cannot join
- 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).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Emory Musculoskeletal Institute, Emory Orthopaedics & Spine Center
Atlanta, Georgia, 30329
Jason Bariteau, MD, 404-778-3350, jason.bariteau@emory.edu
Jason Kadakia, MD
- Recruiting
Emory Sports Medicine Complex and Emory Orthopaedics and Spine Center
Johns Creek, Georgia, 30022
Rishin Kadakia, MD, 404-778-3350, rishin.j.kadakia@emory.edu
About this study
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
Read the 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
- Being tested
- medrol dosepak, HYDROcodone Oral Tablet
- Keywords
- VAS scale: visual analog scale, Medrol Dosepak
- Medical subject headings
- Foot Injuries, Disease, Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
medrol dosepakDrug
Also called Methylprednisolone
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).
HYDROcodone Oral TabletDrug
This study will utilize a prescription of 20 pills of hydrocodone, 5mg each, to be taken as needed for pain, 1 every 6 hours.
| Study group | Role | What they receive |
|---|---|---|
| Medrol | Experimental | The group will be given Medrol Dosepak in a tapered, low-dose manner, orally once a day.
Subjects will be sent home with a pain journal where they will record their pain and nausea 3 times daily starting the day of surgery and the following 7 days along with their daily hydrocodone consumption. These journals will be collected at their 2-week post-op appointment which is scheduled ± 1 week. In this appointment, subjects will also be evaluated for complications. Receives: Drug: medrol dosepak; Drug: HYDROcodone Oral Tablet |
| Standard of Care | Active comparator | Each subject will receive the standard pain regime of both surgeons. This includes a nerve block before surgery for pain prevention. While in surgery, the subject will receive 10 mg of dexamethasone intravenously. Post-surgery, each subject will be instructed to take vitamin C for nerve pain and vitamin D for bone healing. They will also be provided with a prescription of aspirin for deep vein thrombosis (DVT) prophylaxis, ondansetron (Zofran) for nausea, and Colace for constipation relief. Both groups will receive a prescription of 20 5 mg hydrocodone pills to be taken as needed for pain, 1 every 6 hours
Subjects will be sent home with a pain journal where they will record their pain and nausea 3 times starting the day of surgery and the following 7 days along with their daily hydrocodone consumption. Journals will be collected at their 2-week post-op appointment which is scheduled ± 1 week. Subjects will also be evaluated for complications Receives: Drug: HYDROcodone Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline (Day 0), 7 days post op
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
Measured: Baseline, 0.25 months, 1.5 months, 3 months, 6 months
Post operative opioid consumption
Total number of opioids consumed each day will be captured.
Measured: Baseline (Day 0), 7 days post op
Secondary outcomes (2)
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
Measured: 1.5 months, 3 months, 6 months
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
Measured: Baseline (pre operative assessment), Post operation (6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start27 Jan 2025
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Foot Injuries and DisordersStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jason Bariteau, Emory University
- Investigators
- Rishin Kadakia, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06780202
- Sponsor's protocol ID
- STUDY00008454
- Other IDs
- 2025P009012
- Status last verified
- Mar 2026
- First submitted
- 13 Jan 2025
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Medrol Dosepak to Reduce Opioid Consumption in Foot and Ankle Surgical Patients
- ClinicalTrials.gov ID
- NCT06780202
- Acronym / sponsor ID
- STUDY00008454
- Keywords
- VAS scale: visual analog scale, Medrol Dosepak
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- 27 Jan 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 17 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medrol | Experimental | Drug: medrol dosepak, Drug: HYDROcodone Oral TabletThe group will be given Medrol Dosepak in a tapered, low-dose manner, orally once a day. Subjects will be sent home with a pain journal where they will record their pain and nausea 3 times daily starting the day of surgery and the following 7 days along with their daily hydrocodone consumption. These journals will be collected at their 2-week post-op appointment which is scheduled ± 1 week. In this appointment, subjects will also be evaluated for complications. |
| Standard of Care | Active comparator | Drug: HYDROcodone Oral TabletEach subject will receive the standard pain regime of both surgeons. This includes a nerve block before surgery for pain prevention. While in surgery, the subject will receive 10 mg of dexamethasone intravenously. Post-surgery, each subject will be instructed to take vitamin C for nerve pain and vitamin D for bone healing. They will also be provided with a prescription of aspirin for deep vein thrombosis (DVT) prophylaxis, ondansetron (Zofran) for nausea, and Colace for constipation relief. Both groups will receive a prescription of 20 5 mg hydrocodone pills to be taken as needed for pain, 1 every 6 hours Subjects will be sent home with a pain journal where they will record their pain and nausea 3 times starting the day of surgery and the following 7 days along with their daily hydrocodone consumption. Journals will be collected at their 2-week post-op appointment which is scheduled ± 1 week. Subjects will also be evaluated for complications |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -Emory Orthopedic patients undergoing foot and ankle surgery
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| medrol dosepakAlso: MethylprednisoloneMethylprednisolone 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 | Medrol |
| HYDROcodone Oral TabletThis study will utilize a prescription of 20 pills of hydrocodone, 5mg each, to be taken as needed for pain, 1 every 6 hours. | Drug | Medrol, Standard of Care |
Primary outcome
Post operative Nausea
Time frame: 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
Time frame: 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
Time frame: Baseline (Day 0), 7 days post op
Total number of opioids consumed each day will be captured.
2 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rishin Kadakia, MD principal investigator
Emory University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing medrol dosepak and HYDROcodone Oral Tablet in people with Foot Injuries and Disorders and Ankle Injuries and Disorders, run by Emory University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jason Bariteau, MD (404-778-3350, jason.bariteau@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post operative Nausea (time frame: Baseline (Day 0), 7 days post op). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.