Efficacy of Methylprednisolone for Pain Control After ACL Repair
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Meloxicam 15 mg, Medrol 4 MG Oral Tablet Includes Medrol Dosepak, Gabapentin 300 mg, Hydrocodone 5Mg/Acetaminophen 325Mg Tab.
- Who it may be relevant to
- Registry conditions: ACL Surgery, Pain Management. Basic parameters: 13 years — 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy of Methylprednisolone for Pain Control After ACL Repair: A Randomized Controlled Trial
Overview
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.
Detailed description
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.
Interventions
- Drug Meloxicam 15 mg
PO once/day for 1 week - Drug Medrol 4 MG Oral Tablet Includes Medrol Dosepak
PO 6 day taper - Drug Gabapentin 300 mg
PO every 8 hours for 1 week - Drug Hydrocodone 5Mg/Acetaminophen 325Mg Tab
PO 1-2 tabs every 4 hours as needed (total of 28 pills) - Drug Ketorolac 10 Mg Oral Tablet
PO every 6 hours for 5 days
Primary outcome measures
- Numerical Rating Scale (NRS) pain scores [Time frame: Post-op days 0-14, 2 weeks, 6 weeks, and 12 weeks]
Secondary outcome measures (1)
- Opioid consumption after surgery [Time frame: 0-14 days postoperative]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Saint Louis University — St Louis
Identifiers
NCT: NCT07158476 · 34336