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

McMaster University200 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

200

Conditions

Knee Arthroscopy Shoulder Arthroscopy

Interventions

Non-Opioid Prescription and InfographicCOMBINATION_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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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

Locations (3)

Hamilton General Hospital

Hamilton, Ontario, Canada

McMaster University Medical Centre

Hamilton, Ontario, Canada

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, Canada

Outcomes

Primary Outcomes

Total oral morphine equivalents (OMEs)

The primary outcome is the number of total OMEs consumed as determined by a patient-reported medication diary.