Non-Opioid Prescriptions After Arthroscopic Surgery in Canada (NO PAin)

Study Overview
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Brief Summary
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This is a randomized controlled trial of 200 patients between the ages of 18 and 65 years undergoing outpatient knee or shoulder arthroscopy. Patients will be evaluated clinically at 2 and 6 weeks post-operatively. Patients will be recruited from experienced arthroscopic surgeons at 3 hospital sites in Hamilton, Ontario. All research will be conducted according to international standards of Good Clinical Practice and institutional research policies and procedures.

Official Title
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Non-Opioid Prescriptions After Arthroscopic Surgery in Canada (NO PAin): A Randomized Controlled Trial

Conditions
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Knee Arthroscopy, Shoulder Arthroscopy

Intervention / Treatment
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* Combination Product: Non-Opioid Prescription and Infographic


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing outpatient knee or shoulder arthroscopy for any of the following procedures: ACL reconstruction (with or without LET), MPFL reconstruction (not including TTO), Chondroplasty, Meniscectomy, Meniscal repair Meniscal transplant, Microfracture, ACI, Fixation of unstable osteochondral lesion, Subacromial decompression, Rotator cuff repair, Shoulder stabilization, Superior capsule reconstruction, Biceps tenotomy/tenodesis, Capsular release, SLAP repair, Diagnostic arthroscopy, Irrigation and/or debridement, Loose body removal, Synovectomy Patients aged 18 years and older Patients who have the ability to speak, understand, and read English Provision of informed consent Exclusion Criteria: Patients who take or are on a home dose of an opioid medication (i.e. once daily or more) Patients involved in ongoing litigation or compensation claims for any injury (e.g. Work Safety Insurance Board, WSIB) Patients involved in another research study that requires a specific post-operative pain control medication regimen Patients undergoing a knee or shoulder arthroscopy procedure that will likely have an operative time greater than 3 hours Patients who will undergo concomitant open surgery Patients who require overnight admission Patients with a contraindication or allergy to NSAIDs, acetaminophen, or morphine and hydromorphone Patients diagnosed with renal disease or cardiac disease Patients who are scheduled for/plan to have an additional surgical procedure during the 6-week follow-up period Patients who will likely have problems, in the judgement of the investigator, with maintaining follow-up Any other reason(s) the investigator feels is relevant for excluding the patient

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Eligible patients will be randomized using the centralized 24-hour computerized randomization system to allocate patients to the control (standard of care) or intervention (non-opioid prescription and infographic) group.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Non-Opioid Prescription and Infographic<br>The study intervention will involve 3 components: A standardized non-opioid prescription: A prescription for Naproxen 500mg PO BID PRN x 60 tabs, Acetaminophen 1000mg PO Q6H PRN x 100 500mg tabs and Pantoprazole 20mg PO daily x 30 tabs (to be taken only while utilizing Naproxen). In the case of a Naproxen intolerance, a prescription for Meloxicam 15mg PO BID PRN x 60 tabs will be given. A limited opioid rescue prescription: A prescription of Hydromorphone 1mg PO Q4H PRN x 10 tabs will be included on a separate prescription. Patient education infographic: The infographic will contain information on how to take the prescribed medications, along with instructions that the morphine rescue prescription should only be used in cases where the non-opioid pain medications are not providing satisfactory pain control. | Combination Product: Non-Opioid Prescription and Infographic<br>* The study intervention will involve 3 components: A standardized non-opioid prescription: A prescription for Naproxen 500mg PO BID PRN x 60 tabs, Acetaminophen 1000mg PO Q6H PRN x 100 500mg tabs and Pantoprazole 40mg PO daily x 30 tabs (to be taken only while utilizing Naproxen). A limited opioid rescue prescription: A prescription of Hydromorphone 1mg PO Q4H PRN x 10 tabs will be included on a separate prescription. Patient education infographic: The infographic will contain information on how to take the prescribed medications, along with instructions that the morphine rescue prescription should only be used in cases where the non-opioid pain medications are not providing satisfactory pain control.<br>|
| Other: Standard of Care<br>The control group is standard of care, which typically includes a prescription for an opioid. | Combination Product: Non-Opioid Prescription and Infographic<br>* The study intervention will involve 3 components: A standardized non-opioid prescription: A prescription for Naproxen 500mg PO BID PRN x 60 tabs, Acetaminophen 1000mg PO Q6H PRN x 100 500mg tabs and Pantoprazole 40mg PO daily x 30 tabs (to be taken only while utilizing Naproxen). A limited opioid rescue prescription: A prescription of Hydromorphone 1mg PO Q4H PRN x 10 tabs will be included on a separate prescription. Patient education infographic: The infographic will contain information on how to take the prescribed medications, along with instructions that the morphine rescue prescription should only be used in cases where the non-opioid pain medications are not providing satisfactory pain control.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total oral morphine equivalents (OMEs) | The primary outcome is the number of total OMEs consumed as determined by a patient-reported medication diary. | 6 weeks postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain (Visual Analogue Scale, VAS) | The VAS will include a 100mm line, on which patients will be asked to rate their average pain since their surgery. | 6 weeks postoperatively | 
| Patient Satisfaction (Hospital Consumer Assessment of Health Care Provider and Systems Question, HCAHPS) | We used the following modified question from the HCAHPS questionnaire related to satisfaction with pain relief, answered on a Likert scale (never, sometimes, usually, or always): In the time after surgery, how often was your pain well controlled? | 6 weeks postoperatively | 
| OMEs Prescribed | As per the medication diary | 6 weeks postoperatively | 
| Opioid Refills | As per the medication diary | 6 weeks postoperatively | 
| Adverse Events | Adverse events, defined as any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study, will be documented. | 6 weeks postoperatively |