Two Post-Operative Pain Protocols at Discharge for Orthopaedic Patients
This is a single-center, pilot randomized controlled trial designed to evaluate the feasibility of a definitive trial comparing opioid-free discharge prescriptions to usual care (which includes opioids) in patients undergoing major orthopaedic surgery. The main objective is to inform the design and feasibility of the d
| Condition(s) | Orthopaedic Related Pain (Musculoskeletal Pain), Opioid, Pain, Pilot Study |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | This is a single-center, pilot randomized controlled trial designed to evaluate the feasibility of a definitive trial comparing opioid-free discharge prescriptions to usual care (which includes opioids) in patients undergoing major orthopaedic surgery. The main objective is to inform the design and feasibility of the definitive RCT. |
| Who can participate | Inclusion Criteria: 1. Patients 18 years of age or older 2. Underwent a major operative orthopaedic procedure Exclusion Criteria: 1. Contraindication for NSAIDs. 2. Preoperative chronic opioid use (preoperative use of \>14 days and average of \>30 Morphine Milligram Equivalents per day). 3. Active treatment for opioid use disorder. 4. Previous or current illicit drug use. 5. Major surgery for pathologic (cancer-related) condition. 6. Hand surgery. 7. Concurrent operative treatment by another specialty team. 8. Discharged to an extended medical care facility. 9. Incarceration. 10. Women who are pregnant or planning to become pregnant in the next 6 weeks. 11. Expected injury survival of less than 6 weeks. 12. Terminal illness with expected survival of less than 6 weeks. 13. Anticipated probl |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Massachusetts General Hospital |
| Locations | Boston, Massachusetts, United States |
| Start date | 2025-10-06 |
| NCT ID | NCT07265557 |
| Official listing | https://clinicaltrials.gov/study/NCT07265557 |