Methylprednisolone taper plus standard pain medicines after ACL repair
Efficacy of Methylprednisolone for Pain Control After ACL Repair: A Randomized Controlled Trial
We will try adding a methylprednisolone dose-pack to usual pain medicines after ACL repair to see if it lowers pain and reduces opioid use for people aged 13 to 50.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 13 Years to 50 Years |
| Sex | All |
| Sponsor | St. Louis University Academic / other |
| Locations | 1 site (St Louis, Missouri) |
| Trial ID | NCT07158476 on ClinicalTrials.gov |
What this trial studies
This randomized, single-center study enrolls consecutive patients aged 13–50 undergoing primary ACL repair or reconstruction with autograft and follows them for one year. Participants are randomized to a treatment pain regimen that includes a methylprednisolone dose-pack, meloxicam, hydrocodone/acetaminophen, and gabapentin, or to a control regimen of ketorolac, hydrocodone/acetaminophen, and gabapentin. Pain scores and daily opioid pill consumption are reported using the MyCap app the day of surgery and for the first 14–15 postoperative days, and clinic follow-ups occur at 2 weeks, 6 weeks, 12 weeks, and 1 year with collection of PROMs and complications. Demographic, comorbidity, and surgical data are collected from the medical record to compare outcomes between groups.
Who should consider this trial
Good fit: Ideal candidates are people aged 13–50 undergoing primary ACL repair or reconstruction with autograft who can provide informed consent and do not meet the study's exclusion criteria.
Not a fit: Patients with revision or multi-ligament procedures, chronic opioid use, active infection, significant organ dysfunction, immune suppression, or contraindications to steroids/NSAIDs are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If successful, adding a methylprednisolone taper could lower early postoperative pain and reduce opioid consumption and related harms after ACL repair.
How similar studies have performed: Short courses of corticosteroids have reduced pain and opioid use in some surgical settings, but using a methylprednisolone dose-pack after ACL repair in a randomized design is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient undergoing ACL repair or ACL reconstruction with tendon autograft * Age 13-50 years old * Able to provide informed consent or parent/legal guardian is able for minors Exclusion Criteria: * Concurrent and significant injury to other bones or organs (Injury Severity Score of 4 or greater) * Revision ACL reconstruction * Concomitant additional ligament reconstruction or high tibial osteotomy * A history of alcohol abuse, substance abuse or chronic opioid use (filled opioid medication ×2 within 6 months of the surgery) * A history of renal failure (\<60 mL/min/1.73 m2), liver dysfunction (child class, \>B), severe heart disease (NYHA Class 4), diabetes, neurological or psychiatric diseases that may affect pain perception, and pre-existing immune suppression. * A history or active peptic ulcer disease, gastrointestinal bleeding, or current use of anticoagulation. * Patients currently taking oral or injectable glucocorticoids and those who have taken either within 1 month of the procedure. * Patients who are currently pregnant. * Patients who are unable to undergo the multimodal pain standardized protocol including those with comorbidities or medical allergies precluding the use of corticosteroids, gabapentin, hydrocodone, acetaminophen, ketorolac, and/or meloxicam.
Where this trial is running
St Louis, Missouri
- Saint Louis University — St Louis, Missouri, United States (Recruiting)
Study contacts
- Principal investigator: Scott Kaar, MD — St. Louis University
- Study coordinator: Scott Kaar
- Email: scott.kaar@ssmhealth.com
- Phone: 314-617-3405
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.