Efficacy of Methylprednisolone for Pain Control After ACL Repair

Not Applicable

• Conditions: ACL Surgery; Pain Management
• Interventions: Drug: Meloxicam 15 mg; Drug: Medrol 4 MG Oral Tablet Includes Medrol Dosepak; Drug: Gabapentin 300 mg; Drug: Ketorolac 10 Mg Oral Tablet; Drug: Hydrocodone 5Mg/Acetaminophen 325Mg Tab

• Registration Number: NCT07158476
• Lead Sponsor: St. Louis University

Brief 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 Gapabentin. 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.

Study Timeline

• Study First Submitted: 2025-08-28
• Study First Submitted QC: 2025-08-28
• Status Verified: 2025-09
• Study Start: 2025-09-01
• Study First Posted: 2025-09-05
• Last Update Submitted: 2025-09-05
• Last Update Posted: 2025-09-12
• Primary Completion: 2030-09
• Study Completion: 2031-09-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Medrol group	Meloxicam 15 mg	Patients will receive Medrol dose pack, Meloxicam, Hydrocodone/Acetaminophen, and Gabapentin as pain regimen upon discharge from surgery.
Medrol group	Medrol 4 MG Oral Tablet Includes Medrol Dosepak	Patients will receive Medrol dose pack, Meloxicam, Hydrocodone/Acetaminophen, and Gabapentin as pain regimen upon discharge from surgery.
Medrol group	Gabapentin 300 mg	Patients will receive Medrol dose pack, Meloxicam, Hydrocodone/Acetaminophen, and Gabapentin as pain regimen upon discharge from surgery.
Medrol group	Hydrocodone 5Mg/Acetaminophen 325Mg Tab	Patients will receive Medrol dose pack, Meloxicam, Hydrocodone/Acetaminophen, and Gabapentin as pain regimen upon discharge from surgery.
No Medrol group	Gabapentin 300 mg	Patients will receive Ketorolac, Hydrocodone/Acetaminophen, and Gabapentin as pain regimen upon discharge from surgery.
No Medrol group	Hydrocodone 5Mg/Acetaminophen 325Mg Tab	Patients will receive Ketorolac, Hydrocodone/Acetaminophen, and Gabapentin as pain regimen upon discharge from surgery.
No Medrol group	Ketorolac 10 Mg Oral Tablet	Patients will receive Ketorolac, Hydrocodone/Acetaminophen, and Gabapentin as pain regimen upon discharge from surgery.

Primary Outcome Measures

Name	Time	Method
Numerical Rating Scale (NRS) pain scores	Post-op days 0-14, 2 weeks, 6 weeks, and 12 weeks	Zero is equivalent to no pain and 10 indicates the worst possible pain

Secondary Outcome Measures

Name	Time	Method
Opioid consumption after surgery	0-14 days postoperative	Calculated using Morphine milligram equivalents (MME)

Trial Locations

Locations (1)

Saint Louis University; 🇺🇸 St Louis, Missouri, United States