Using Medrol Dosepak to manage pain after knee surgery
An Oral Methylprednisolone Taper Within a Multimodal Analgesic Regimen After Total Knee Arthroplasty: a Double-Blind Randomized Placebo-Controlled Trial
This study is testing if a medication called Medrol can help people feel less pain and recover better after knee surgery compared to a placebo.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 420 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rush University Medical Center Academic / other |
| Locations | 1 site (Oak Brook, Illinois) |
| Trial ID | NCT05097976 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of an oral taper of methylprednisolone in managing acute postoperative pain and improving function following outpatient total knee arthroplasty (TKA). Starting on the first day after surgery, patients will receive either methylprednisolone or a placebo to assess its impact on pain levels, opioid consumption, nausea, and complications during the first week of recovery. The study aims to demonstrate that those receiving methylprednisolone will experience less pain and better functional outcomes at three and six weeks post-surgery compared to those on placebo.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older undergoing primary total knee arthroplasty for osteoarthritis.
Not a fit: Patients with chronic corticosteroid or opioid use, or those with certain medical conditions such as infections or severe comorbidities, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce postoperative pain and opioid use for patients undergoing knee surgery.
How similar studies have performed: Previous studies have shown that corticosteroids can effectively reduce postoperative pain, suggesting a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Any patient undergoing primary TKA with a diagnosis of osteoarthritis •≥ 18 years old * Willingness to undergo randomization Exclusion Criteria: * Reported chronic corticosteroid or opiate use * Suspected or confirmed periprosthetic joint infection * Revision TKA * Primary diagnosis other than osteoarthritis, including avascular necrosis, fracture, or post-traumatic arthritis * American Society of Anesthesiologists (ASA) score ≥ 4 * Reported history of liver disease, renal disease, or diabetes mellitus * Current systemic fungal infection or other local infection * Immunocompromised or immunosuppressed * Current peptic ulcer disease * History of hypothyroidism, psychosis, heart failure, myasthenia gravis, ocular herpes simplex virus, or systemic sclerosis * Women with reported current pregnancy * Known hypersensitivity to methylprednisolone •≤ 18 years old * Inability to take oral medications * Unable to provide consent
Where this trial is running
Oak Brook, Illinois
- Rush Oak Brook Outpatient Center — Oak Brook, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Craig Della Valle, MD — Rush University Medical Center
- Study coordinator: Anne DeBenedetti
- Email: anne.debenedetti@rushortho.com
- Phone: 3124322468
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.