Two Post-Operative Pain Protocols at Discharge for Orthopaedic Patients
NCT ID: NCT07265557
Last Updated: 2026-01-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2025-10-06
2026-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Discharge pain medication prescription without opioids
The treatment arm will receive standard non-opioid analgesia, with the specific medication (e.g., ibuprofen, paracetamol, ketorolac) determined by the treating physician.
Discharge pain medication prescription
The patients in this pilot RCT will either receive a discharge prescription with or without opioids. The specific non-opioid medication (e.g., ibuprofen, paracetamol, ketorolac) determined by the treating physician. The dosage of the prescription including opioids is also determined by the treating physician.
Usual care discharge prescription (with opioids)
The control arm will receive the standard pain medication prescription, including opioids. The specific dosage and medication is determined by the treating physician.
Discharge pain medication prescription
The patients in this pilot RCT will either receive a discharge prescription with or without opioids. The specific non-opioid medication (e.g., ibuprofen, paracetamol, ketorolac) determined by the treating physician. The dosage of the prescription including opioids is also determined by the treating physician.
Interventions
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Discharge pain medication prescription
The patients in this pilot RCT will either receive a discharge prescription with or without opioids. The specific non-opioid medication (e.g., ibuprofen, paracetamol, ketorolac) determined by the treating physician. The dosage of the prescription including opioids is also determined by the treating physician.
Eligibility Criteria
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Inclusion Criteria
2. Underwent a major operative orthopaedic procedure
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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McMaster University
OTHER
Massachusetts General Hospital
OTHER
Responsible Party
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Arun Aneja, MD, PhD
Principal Investigator
Principal Investigators
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Arun Aneja, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Mass
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2025P002285
Identifier Type: -
Identifier Source: org_study_id
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