Efficacy of Methylprednisolone for Pain Control After ACL Repair

NCT07158476 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 34336
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Keywords

pain; opioids; orthopedic surgery

Outcome Measures

Primary Outcomes (1)

• Numerical Rating Scale (NRS) pain scores

  Zero is equivalent to no pain and 10 indicates the worst possible pain

  Post-op days 0-14, 2 weeks, 6 weeks, and 12 weeks

Secondary Outcomes (1)

• Opioid consumption after surgery

  0-14 days postoperative

Study Arms (2)

Medrol group

ACTIVE COMPARATOR

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

Drug: Meloxicam 15 mg; Drug: Medrol 4 MG Oral Tablet Includes Medrol Dosepak; Drug: Gabapentin 300 mg; Drug: Hydrocodone 5Mg/Acetaminophen 325Mg Tab

No Medrol group

ACTIVE COMPARATOR

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

Drug: Gabapentin 300 mg; Drug: Hydrocodone 5Mg/Acetaminophen 325Mg Tab; Drug: Ketorolac 10 Mg Oral Tablet

Interventions

Meloxicam 15 mg DRUG

PO once/day for 1 week

Medrol group

Medrol 4 MG Oral Tablet Includes Medrol Dosepak DRUG

PO 6 day taper

Medrol group

Gabapentin 300 mg DRUG

PO every 8 hours for 1 week

Medrol group; No Medrol group

Hydrocodone 5Mg/Acetaminophen 325Mg Tab DRUG

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

Medrol group; No Medrol group

Ketorolac 10 Mg Oral Tablet DRUG

PO every 6 hours for 5 days

No Medrol group

Eligibility Criteria

• Age: 13 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. Louis University: lead

Study Sites (1)

Saint Louis University

St Louis, Missouri, 63110, United States

RECRUITING

MeSH Terms

Conditions

Agnosia; Pain

Interventions

Meloxicam; Methylprednisolone; Gabapentin; Hydrocodone; Acetaminophen; Ketorolac; Tablets

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiazines; Sulfur Compounds; Organic Chemicals; Thiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Amines; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins; Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Acetanilides; Anilides; Amides; Aniline Compounds; Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Scott Kaar, MD

  St. Louis University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Scott Kaar

CONTACT

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

Allison Gruender

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Orthopaedic Surgery

Study Record Dates

• First Submitted: August 28, 2025
• First Posted: September 5, 2025
• Study Start: October 21, 2025
• Primary Completion (Estimated): September 1, 2030
• Study Completion (Estimated): September 1, 2031
• Last Updated: October 24, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)