Efficacy of Methylprednisolone for Pain Control After ACL Repair

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age13-50
SponsorSt. Louis University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: Medrol groupActive comparator 4 interventions
Group B: No Medrol groupActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

Numerical Rating Scale (NRS) pain scores

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

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

Secondary outcomes

1

Opioid consumption after surgery

Calculated using Morphine milligram equivalents (MME)

Time frame
0-14 days postoperative

Other outcomes

Sponsors and contacts

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