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NCT Number: NCT07158476

Efficacy of Methylprednisolone for Pain Control After ACL Repair

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.

Recruiting

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Key information

Age range

13 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Saint Louis University

St Louis, Missouri, 63110, United States

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Meloxicam 15 mg

Drug

PO once/day for 1 week

Medrol 4 MG Oral Tablet Includes Medrol Dosepak

Drug

PO 6 day taper

Gabapentin 300 mg

Drug

PO every 8 hours for 1 week

Hydrocodone 5Mg/Acetaminophen 325Mg Tab

Drug

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

Ketorolac 10 Mg Oral Tablet

Drug

PO every 6 hours for 5 days

Primary outcomes

  1. Numerical Rating Scale (NRS) pain scores

    Time frame: 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 outcomes

  1. Opioid consumption after surgery

    Time frame: 0-14 days postoperative

    Calculated using Morphine milligram equivalents (MME)

Study contacts

Contact information is provided by the study sponsor or research team.

Allison Gruender

CONTACT

[email protected]

314-617-3406

Scott Kaar

CONTACT

[email protected]

314-617-3405

Sponsors and collaborators

Lead sponsor

St. Louis University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2030
Study completion
2031
First posted
Sep 5, 2025
Registry last updated
Oct 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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