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Recruiting
NCT07265557
Two Post-Operative Pain Protocols at Discharge for Orthopaedic Patients
Conditions: Orthopaedic Related Pain (Musculoskeletal Pain), Opioid, Pain, Pilot Study
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 100
Sponsor: Massachusetts General Hospital
Location: Mass Boston Massachusetts
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.
Eligibility Criteria
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 problems, in the judgment of research personnel, with maintaining follow-up with the patient.
14. Currently enrolled in a trial that does not permit co-enrollment.
15. Prior enrollment in the trial.
16. Unable to obtain informed consent.
17. Non-English speaking
18. Eligible patient was not approached prior to hospital discharge (missed participant).
19. Did not provide informed consent (declined participation).
20. Other reason to exclude the patient, as approved by the Principal Investigator
Source: ClinicalTrials.gov (NCT07265557). StuddyBuddy aggregates publicly available trial information.