NCT07158476

Efficacy of Methylprednisolone for Pain Control After ACL Repair

Efficacy of Methylprednisolone for Pain Control After ACL Repair: A Randomized Controlled Trial

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: St. Louis University · Academic / Other
• Sex: All
• Age: 13 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

Opioids are commonly used after orthopedic surgery for pain control but have been shown to increase complications, surgeries, readmissions, and risk for opioid use disorder. The purpose of this study is to investigate the impact of adding a methylprednisolone taper to the pain regimen after ACL repair surgery to determine if this results in decreased postoperative pain and opioid use without increasing complications.

Detailed description

The study is to include consecutive patients who undergo ACL repair by fellowship trained surgeons at a single institution with minimum 12 week follow up. All patients between the ages of 13-50 who are willing and able to provide informed consent will be included. Patients will be assessed preoperatively and then at 2 weeks, 6 weeks,12 weeks, and 1 year clinic visits, which is standard of care. The patient will fill out 2 questions on the MyCap app the day of surgery and for 14 days following surgery for pain scores and 15 days for amount of opioid pills consumed the day prior. Patient demographic, comorbidity, and surgical data will be collected from the medical record, including age, sex, BMI, smoking status, and diabetic status. Patients will be randomized to the treatment or control group. The treatment group will receive the following pain regimen after surgery: Medrol dose pack, Meloxicam, Hydrocodone/Acetaminophen, and Gabapentin. The control group will be prescribed: Ketoralac, Hydrocodone/Acetaminophen, and Gabapentin. Pain reporting and opioid consumption will be assessed via the MyCap app for two weeks following surgery. Patients will be followed at standard of care clinic appointments for 1 year. PROMs data will be collected at that time, in addition to any complications.

Conditions

• ACL Surgery
• Pain Management

Interventions

Type	Name	Description
DRUG	Meloxicam 15 mg	PO once/day for 1 week
DRUG	Medrol 4 MG Oral Tablet Includes Medrol Dosepak	PO 6 day taper
DRUG	Gabapentin 300 mg	PO every 8 hours for 1 week
DRUG	Hydrocodone 5Mg/Acetaminophen 325Mg Tab	PO 1-2 tabs every 4 hours as needed (total of 28 pills)
DRUG	Ketorolac 10 Mg Oral Tablet	PO every 6 hours for 5 days

Timeline

• Start date: 2025-10-21
• Primary completion: 2030-09-01
• Completion: 2031-09-01
• First posted: 2025-09-05
• Last updated: 2025-10-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study