drugset / Trial / NCT05974423

Randomized Trial of Narcotic vs Non-Narcotic Pain Modulation After Labrum Repair

NCT05974423

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to determine if patients age 15 to 30 years old being treated for shoulder labrum repair and SLAP lesions have significant differences in pain levels postoperatively when treated with a combination therapy of ibuprofen, and acetaminophen compared to oxycodone. Participants will be randomly placed into either the control arm and receive scripts for non-narcotic medications (Tylenol and Ibuprofen) and opioids, or the experimental arm of the study. receiving only a prescription for the non-narcotic medications. Every patient will receive a preoperative Exparel nerve block as is the standard of care for this procedure. Both groups will fill out a pain journal for 14 days following surgery and complete a pill count at the first postoperative visit to validate the amount of pain medication documented in the pain journal.

Timeline

Start
2022-12-16
Primary completion
2024-12-01
Completion
2025-12-01

Publications

Drugs

EvaluationDrugModalityDoseRoute
Comparator Oxycodone Other / unclassified 5 mg
Comparator Acetaminophen Small molecule 1000 mg
Comparator Ibuprofen Small molecule 600 mg