Saint Louis University
St Louis, Missouri, 63110, United States
Location status: Recruiting
NCT Number: NCT07158476
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.
Interested in participating?
Request Info13 year–50 year
All sexes
Interventional
Phase 4
St Louis, Missouri, 63110, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
PO once/day for 1 week
PO 6 day taper
PO every 8 hours for 1 week
PO 1-2 tabs every 4 hours as needed (total of 28 pills)
PO every 6 hours for 5 days
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
Time frame: 0-14 days postoperative
Calculated using Morphine milligram equivalents (MME)
Contact information is provided by the study sponsor or research team.
Allison Gruender
CONTACT
Scott Kaar
CONTACT
St. Louis University
Other
Efficacy of Methylprednisolone for Pain Control After ACL Repair: A Randomized Controlled Trial
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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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