A Phase 3 Study Comparing Multimodal Pain Control With or Without Opioids After Orthopaedic Surgery

What this Trial Is About

Researchers are evaluating a multimodal pain control approach for patients undergoing orthopedic surgeries, aiming to reduce or eliminate the use of opioid medications after surgery. This trial compares the effectiveness of pain management with and without opioids to address concerns related to prolonged opioid use and postoperative outcomes. The study is a double-blinded randomized controlled trial focused on improving pain control while minimizing opioid dependency risks. Participants will receive a standard multimodal pain control regimen combined with education. They will be randomly assigned to one of two groups one receiving encapsulated Oxycodone 5 mg tablets or the other receiving placebo tablets. Both groups will take their assigned tablets orally every six hours as needed after surgery. This study includes an extensive follow-up period to monitor outcomes related to pain, satisfaction, opioid consumption, side effects, and complications. Throughout the trial, participants will report their pain levels three times daily for the first two weeks and at multiple points up to five years after surgery. Researchers will also track patient satisfaction, functional scores, quality of life measures, opioid use, length of hospital stay, and any complications. This comprehensive monitoring will help identify risks for prolonged opioid use and support future opioid-free surgical practices.

Opioid-Free Orthopaedics