Opioid, Orthopaedic Related Pain (Musculoskeletal Pain), Pain, Pilot Study
Conditions
Keywords
Opioid, Pilot study, Musculoskeletal Pain
Brief 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.
Detailed description
This is a single-center pilot RCT of at least 100 participants (20 participants from each subspecialty including trauma, arthroplasty, foot and ankle, spine, and sports) who undergo major orthopaedic surgery. Eligible and consenting patients will be randomized to either a discharge pain medication prescription without opioids or a usual care discharge pain medication (with opioids). The overarching objective of the pilot study is to inform the design and feasibility of the definitive RCT. For this pilot trial the investigators will measure feasibility against traffic light criteria based on enrollment metrics, treatment allocation adherence, and on data collection. Furthermore, this pilot RCT will compare the effectiveness of discharge pain medication without opioids to usual care discharge pain medication (with opioids) on opioid use and pain interference for patients who have undergone major orthopaedic surgery.
Interventions
OTHERDischarge 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.
Sponsors
Massachusetts General Hospital
McMaster University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of patient enrollment and treatment allocation | From enrollment to the end of the follow-up phase at 6 weeks | Participant enrollment will be assessed by monitoring screening and enrollment metrics, including: * Participant enrollment * Feasibility of treatment allocation * Data collection methods (Proportion of participants with missing data) * Compliance with the protocol (Proportion of randomization errors, proportion of patients who complete each questionnaire at each of the follow-up, proportion of patients who withdraw from the trial, proportion of participants who are lost to follow-up) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Use | From enrollment to the end of the follow-up at 6 weeks | Opioid usage assessed at 2 weeks and 6 weeks post-randomization |
| Pain Interference | From enrollment to the end of the follow-up at 6 weeks | Pain interference will be assessed using the Brief Pain Inventory at 2 weeks and 6 weeks from randomization. |
Countries
United States
Contacts
CONTACTArun Aneja, MD, PhD
CONTACTSheila Sprague, PhD
PRINCIPAL_INVESTIGATORArun Aneja, MD PhD
Massachusetts General Hospital
Outcome results
None listed