Recruiting

Methylprednisolone Taper

Sponsor:

St. Louis University

Code:

NCT07158476

Conditions

ACL Surgery

Pain Management

Eligibility Criteria

Sex: All

Age: 13 - 50

Healthy Volunteers: Not accepted

Interventions

Meloxicam 15 mg

Medrol 4 MG Oral Tablet Includes Medrol Dosepak

Gabapentin 300 mg

Hydrocodone 5Mg/Acetaminophen 325Mg Tab

Ketorolac 10 Mg Oral Tablet

Study Details

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.

Conditions

ACL Surgery

Pain Management

Study ID

NCT07158476

Start date

Oct 21, 2025

Status verified date

Oct, 2025

Completion date

Sep, 2031

Anticipated

Primary completion date

Sep, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13 - 50

Healthy Volunteers: Not accepted

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

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: Medrol group

Patients will receive Medrol dose pack, Meloxicam, Hydrocodone/Acetaminophen, and Gabapentin as pain regimen upon discharge from surgery.

active comparator: No Medrol group

Patients will receive Ketorolac, Hydrocodone/Acetaminophen, and Gabapentin as pain regimen upon discharge from surgery.

Interventions

Meloxicam 15 mg

PO once/day for 1 week

Medrol 4 MG Oral Tablet Includes Medrol Dosepak

PO 6 day taper

Gabapentin 300 mg

PO every 8 hours for 1 week

Hydrocodone 5Mg/Acetaminophen 325Mg Tab

PO 1-2 tabs every 4 hours as needed (total of 28 pills)

Ketorolac 10 Mg Oral Tablet

PO every 6 hours for 5 days

Primary outcome measure

  • Numerical Rating Scale (NRS) pain scores [ Time Frame: Post-op days 0-14, 2 weeks, 6 weeks, and 12 weeks ]

Central Contacts and Locations

Central contacts

Scott Kaar

314-617-3405scott.kaar@ssmhealth.com

Allison Gruender

314-617-3406allison.gruender@health.slu.edu

Locations

Saint Louis University

Recruiting

St Louis, Missouri, United States, 63110

More Information

Sponsor

St. Louis University

Last update posted

Oct 24, 2025

Last verified

Oct, 2025

Keywords

  • pain
  • opioids
  • orthopedic surgery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by St. Louis University on 2025-10-24.