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

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-24

Study Completion Date

2022-04-01

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.

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Detailed Description

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Conditions

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Knee Arthroscopy Shoulder Arthroscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Given that patients in the intervention group will receive a pamphlet explaining how to use their prescription allocation, patient blinding is not feasible. Surgeons cannot be blinded as they will need to sign the prescriptions and provide any necessary advice about the medications being prescribed. Outcome assessors and data analysts will be blinded.

Study Groups

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Non-Opioid Prescription and Infographic

The study intervention will involve 3 components:

1. 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.
2. A limited opioid "rescue prescription": A prescription of Hydromorphone 1mg PO Q4H PRN x 10 tabs will be included on a separate prescription.
3. 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.

Group Type ACTIVE_COMPARATOR

Non-Opioid Prescription and Infographic

Intervention Type COMBINATION_PRODUCT

The study intervention will involve 3 components:

1. 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).
2. A limited opioid "rescue prescription": A prescription of Hydromorphone 1mg PO Q4H PRN x 10 tabs will be included on a separate prescription.
3. 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.

Standard of Care

The control group is standard of care, which typically includes a prescription for an opioid.

Group Type OTHER

Non-Opioid Prescription and Infographic

Intervention Type COMBINATION_PRODUCT

The study intervention will involve 3 components:

1. 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).
2. A limited opioid "rescue prescription": A prescription of Hydromorphone 1mg PO Q4H PRN x 10 tabs will be included on a separate prescription.
3. 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.

Interventions

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Non-Opioid Prescription and Infographic

The study intervention will involve 3 components:

1. 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).
2. A limited opioid "rescue prescription": A prescription of Hydromorphone 1mg PO Q4H PRN x 10 tabs will be included on a separate prescription.
3. 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.

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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Inclusion Criteria

1. 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
2. Patients aged 18 years and older
3. Patients who have the ability to speak, understand, and read English
4. Provision of informed consent

Exclusion Criteria

1. Patients who take or are on a home dose of an opioid medication (i.e. once daily or more)
2. Patients involved in ongoing litigation or compensation claims for any injury (e.g. Work Safety Insurance Board, WSIB)
3. Patients involved in another research study that requires a specific post-operative pain control medication regimen
4. Patients undergoing a knee or shoulder arthroscopy procedure that will likely have an operative time greater than 3 hours
5. Patients who will undergo concomitant open surgery
6. Patients who require overnight admission
7. Patients with a contraindication or allergy to NSAIDs, acetaminophen, or morphine and hydromorphone
8. Patients diagnosed with renal disease or cardiac disease
9. Patients who are scheduled for/plan to have an additional surgical procedure during the 6-week follow-up period
10. Patients who will likely have problems, in the judgement of the investigator, with maintaining follow-up
11. Any other reason(s) the investigator feels is relevant for excluding the patient

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No