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| Name | Class |
|---|---|
| McMaster University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Discharge pain medication prescription without opioids | Experimental | The treatment arm will receive standard non-opioid analgesia, with the specific medication (e.g., ibuprofen, paracetamol, ketorolac) determined by the treating physician. |
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| Usual care discharge prescription (with opioids) | Active Comparator | The control arm will receive the standard pain medication prescription, including opioids. The specific dosage and medication is determined by the treating physician. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Discharge pain medication prescription | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of patient enrollment and treatment allocation | Participant enrollment will be assessed by monitoring screening and enrollment metrics, including:
| From enrollment to the end of the follow-up phase at 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid Use | Opioid usage assessed at 2 weeks and 6 weeks post-randomization | From enrollment to the end of the follow-up at 6 weeks |
| Pain Interference | Pain interference will be assessed using the Brief Pain Inventory at 2 weeks and 6 weeks from randomization. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Arun Aneja, MD, PhD | Contact | 617-726-6546 | aaneja@mgh.harvard.edu | |
| Sheila Sprague, PhD | Contact | sprags@mcmaster.ca |
| Name | Affiliation | Role |
|---|---|---|
| Arun Aneja, MD PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mass | Recruiting | Boston | Massachusetts | 02114 | United States |
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| ID | Term |
|---|---|
| D059352 | Musculoskeletal Pain |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| From enrollment to the end of the follow-up at 6 weeks |
| D013568 | Pathological Conditions, Signs and Symptoms |