NCT04566250

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: McMaster University · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Knee Arthroscopy
• Shoulder Arthroscopy

Interventions

Type	Name	Description
COMBINATION_PRODUCT	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.

Timeline

• Start date: 2021-02-24
• Primary completion: 2022-04-01
• Completion: 2022-04-01
• First posted: 2020-09-28
• Last updated: 2024-11-21

Locations

3 sites across 1 country: Canada