Medrol Dosepak for Foot and Ankle Surgery

Recruiting at 1 trial location

Overseen By Jason Bariteau, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Emory University

Disqualifiers: Severe heart disease, Renal failure, Liver dysfunction, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 1 week

180 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a 6-day course of Medrol Dosepak (a corticosteroid medication) can reduce pain, nausea, and the need for opioids in individuals undergoing foot and ankle surgery. Researchers aim to assess how this treatment affects post-surgery complications and patient-reported outcomes. Participants will keep a pain journal for two weeks following surgery. Those undergoing foot and ankle surgery at Emory Orthopedics, without additional major health issues, might be suitable for this study. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important medical advancements.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is there any evidence suggesting that Medrol Dosepak is likely to be safe for humans?

Research has shown that Medrol Dosepak, containing methylprednisolone, is usually well-tolerated in low doses for short durations. Previous studies found that high doses of methylprednisolone during surgeries can reduce the body's stress response without major side effects. In this trial, the dose is much lower and taken over six days, suggesting even greater safety.

Some people taking Medrol Dosepak have experienced common side effects like an upset stomach or trouble sleeping, but these are mostly mild. Reports of serious side effects with this kind of short-term, low-dose use are absent.

This trial is in Phase 2, indicating that earlier studies have already demonstrated the treatment's safety. Overall, evidence suggests Medrol Dosepak is safe for short-term use in surgeries, such as those for the foot and ankle. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard of care for pain management after foot and ankle surgery, which includes nerve blocks and a range of medications like dexamethasone and hydrocodone, Medrol Dosepak offers a unique approach. Researchers are excited about Medrol because it is administered in a tapered, low-dose manner, potentially reducing the need for stronger pain relief medications. This method aims to manage inflammation and pain with fewer side effects, thanks to its specific corticosteroid formulation. By targeting inflammation directly, Medrol Dosepak could improve recovery times and reduce complications compared to traditional pain management strategies.

What evidence suggests that Medrol Dosepak might be an effective treatment for pain and nausea in foot and ankle surgery?

Research has shown that the Medrol Dosepak, containing methylprednisolone, can reduce pain and improve movement after surgery. Methylprednisolone lowers swelling, which aids in recovery. In this trial, one group of participants will receive the Medrol Dosepak in a tapered, low-dose manner. Studies have found that patients using the Medrol Dosepak experienced less pain and required fewer pain-relief medicines post-surgery. By reducing pain and swelling, this treatment might help patients recover more easily and quickly after foot and ankle surgeries. ^{1 3 5 6 7}

Who Is on the Research Team?

Rishin Kadakia, MD

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

This trial is for patients undergoing foot and ankle surgeries who are looking to manage pain, nausea, and reduce opioid use post-surgery. Participants should not have conditions that could complicate wound healing or be at risk of tendon injuries.

Inclusion Criteria

I am an Emory Orthopedic patient having foot or ankle surgery.

Exclusion Criteria

I do not have severe heart, kidney, liver issues, stomach ulcers, diabetes, arthritis, or mental health conditions that affect how I feel pain.

Pre-existing immune suppression

History of alcohol or medical abuse, including prior opioid abuse

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 6-day low-dose methylprednisolone course starting on the day of surgery

1 week

1 visit (in-person) for surgery

Post-operative Monitoring

Participants record pain, nausea, and opioid consumption in a pain journal for 7 days post-surgery

1 week

1 visit (in-person) at 2-week post-op appointment

Follow-up

Participants are monitored for complications and patient-reported outcomes at post-operative appointments

6 months

Multiple visits (in-person) at 1.5, 3, and 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Medrol Dosepak

Trial Overview The study tests a 6-day course of low-dose methylprednisolone (Medrol Dosepak) against standard care to see if it can decrease pain, nausea, and the need for opioids after surgery. It also looks at surgical complications and patient satisfaction.

How Is the Trial Designed?

Group I: Medrol Experimental Treatment 2 Interventions

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.

Group II: Standard of Care Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

Published Research Related to This Trial

A study involving 50 medical personnel showed that their skills and knowledge in using newer dry powder inhalers (budesonide and salmeterol) were significantly lower than for conventional metered-dose inhalers (MDIs), with average demonstration scores of only 49.9% for budesonide and 64.2% for salmeterol.

The findings indicate a critical gap in training among medical personnel, particularly among registered nurses and medical residents, which likely contributes to patients' difficulties in using inhalers correctly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does introduction of new "easy to use" inhalational devices improve medical personnel's knowledge of their proper use? Chopra, N., Oprescu, N., Fask, A., et al.[2015]

In a 4-month study involving 2179 adult asthma patients, the extrafine formulation of beclomethasone/formoterol (BDP/F pMDI HFA) significantly improved asthma control, as shown by a decrease in the Asthma Control Questionnaire score from 1.62 to 0.94 (p < 0.001).

Patients reported better compliance with their medication, with those forgetting to take their medication dropping from 49.7% to 27.1% (p < 0.001), and most patients expressed satisfaction with the inhaler device, preferring it over dry powder inhalers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improvement of asthma control in adult patients using extrafine inhaled beclomethasone/formoterol fixed combination as maintenance therapy as well as maintenance and reliever therapy - CONTROL study. Dębowski, T., Marko, M., Rogala, B., et al.[2023]

In a study of 140 critical-dose drugs, it was found that the maximum recommended therapeutic doses (MRTD) from the FDA and the Summary of Product Characteristics (SPC) often differed, with 37% being similar, 32% higher, and 31% lower, highlighting inconsistencies in dosing guidelines.

The analysis of 633 electronically prescribed drugs revealed that prescription rates of excessive doses were significantly higher when using FDA MRTD values (6.1%) compared to SPC values (2.5%), indicating the need for careful selection of dosing databases to prevent overdoses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Detection and prevention of prescriptions with excessive doses in electronic prescribing systems. Seidling, HM., Al Barmawi, A., Kaltschmidt, J., et al.[2018]

In a randomized, double-blind trial involving 94 patients with acute asthma, the addition of flunisolide to salbutamol significantly improved lung function (FEV1 and PEFR) compared to salbutamol alone, particularly at 90, 120, 150, and 180 minutes after treatment.

The study suggests that high and cumulative doses of inhaled flunisolide are effective for patients with prolonged asthma symptoms (over 24 hours) before arriving at the emergency room, indicating its potential as a beneficial therapy in acute asthma management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inhaled flunisolide for acute severe asthma. Rodrigo, G., Rodrigo, C.[2021]

A new multi-stage Bayesian hierarchical Poisson model was developed to estimate adverse event rates in randomized controlled trials using the MedDRA coding system, which helps organize and analyze reported adverse events more effectively.

The model improves the analysis of rare adverse events by aggregating data at higher levels within the MedDRA structure, demonstrating better performance in simulations and real-world applications compared to existing methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

BAHAMA: A Bayesian Hierarchical Model for the Detection of MedDRA&#174;-Coded Adverse Events in Randomized Controlled Trials. Revers, A., Hof, MH., Zwinderman, AH.[2022]

The safety profile of a drug post-registration is primarily informed by spontaneous reports from healthcare professionals, highlighting the importance of ongoing monitoring after a drug is approved.

This article focuses on analyzing adverse drug reactions reported to the Regional Centre of Monitoring Adverse Drug Reactions in Poznań, emphasizing the need for systematic evaluation of these reports to ensure drug safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The safety of pharmacotherapy in the light of monitoring adverse drug reaction]. Jabłecka, A., Korzeniowska, K.[2013]

In a study of 2,146 patients undergoing elective knee, hip, and spine surgeries for degenerative conditions, the overall adverse event rate was 27%, with spinal surgeries having the highest rate of severe adverse events.

Key risk factors for adverse events included increasing age, male sex, longer operative duration, longer hospital stays, and undergoing revision surgery, highlighting the need for careful patient assessment and procedural efficiency improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors Associated with Adverse Events in Inpatient Elective Spine, Knee, and Hip Orthopaedic Surgery. Millstone, DB., Perruccio, AV., Badley, EM., et al.[2017]

In a study involving 416 asthmatic patients, switching from fluticasone/salmeterol to extrafine beclometasone/formoterol maintained lung function and asthma control over a 12-week period, demonstrating clinical equivalence between the two treatments.

Both treatments showed no significant differences in pre-dose lung function (FEV1) and maintained asthma control, with no safety issues reported, indicating that the switch is safe and effective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stepping-across controlled asthmatic patients to extrafine beclometasone/formoterol combination. Barnes, N., van Noord, JA., Brindicci, C., et al.[2017]

The Airmax inhaler, utilizing the X-ACT system, delivers consistent and accurate doses of formoterol, achieving 97% and 100% of the labeled dose for 6 and 12 microg strengths, respectively, across a large sample size (n=140 for 6 microg and n=440 for 12 microg).

The inhaler produces a fine particle fraction (FPF) of 44.4%, indicating a significant proportion of the aerosolized drug is in a respirable size, which enhances the efficacy of the medication for patients with respiratory conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delivery of formoterol from a novel multi-dose inhaler Airmax. Zeng, XM., Jones, S., O'Leary, D., et al.[2019]

A new ontology model was developed to systematically organize and represent adverse drug reactions (ADRs) from package inserts of quinolone drugs, which included data from 165 package inserts and resulted in a comprehensive ADR ontology with 2879 classes and 15,711 semantic relations.

This structured approach allows for better identification and analysis of ADRs, enhancing understanding and safety in medication prescriptions, and could potentially reduce morbidity and healthcare costs associated with unexpected drug reactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ontological Organization and Bioinformatic Analysis of Adverse Drug Reactions From Package Inserts: Development and Usability Study. Li, X., Lin, X., Ren, H., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06780202

Assessment of Medrol Dosepak to Reduce Opioid ... 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- ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0749806306010474

Survey of Orthopaedic and Sports Medicine Physicians ... Purpose: To study the use of a methylprednisolone taper (Medrol Dosepak; Pfizer, New York, NY) short-term oral corticosteroid treatment modality by sports ...

3. withpower.com withpower.com/trial/medrol-dosepak-for-foot-and-ankle-surgery-0b9de

Medrol Dosepak for Foot and Ankle Surgery This trial is for patients undergoing foot and ankle surgeries who are looking to manage pain, nausea, and reduce opioid use post-surgery. Participants should ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/17157723/

Survey of orthopaedic and sports medicine physicians ... Results: Total response rate was 41% (1,290/3,167), US response rate 43% (1,247/2,906), and international response rate 16% (43/261). Prescribing of MDP for ...

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06780202/assessment-of-medrol-dosepak-to-reduce-opioid-consumption-in-foot-and-ankle-surgical-patients

Assessment of Medrol Dosepak to Reduce Opioid ... 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 ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/11085349/

Risks and benefits of preoperative high dose ... A single preoperative high dose of methylprednisolone (15 to 30 mg/kg) has been advocated in surgery, because it may inhibit the surgical stress response.

7. drugs.com drugs.com/mtm/medrol-dosepak.html

Medrol Dosepak Uses, Side Effects & Warnings This medicine can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using Medrol Dosepak. You should ...