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

Not Applicable

Completed

• Conditions: Shoulder Arthroscopy; Knee Arthroscopy
• Interventions: Combination Product: Non-Opioid Prescription and Infographic

• Registration Number: NCT04566250
• Lead Sponsor: McMaster University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-22
• Study First Submitted QC: 2020-09-22
• Study First Posted: 2020-09-28
• Study Start: 2021-02-24
• Primary Completion: 2022-04-01
• Study Completion: 2022-04-01
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-19
• Last Update Posted: 2024-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of Care	Non-Opioid Prescription and Infographic	The control group is standard of care, which typically includes a prescription for an opioid.
Non-Opioid Prescription and Infographic	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
OMEs Prescribed	6 weeks postoperatively	As per the medication diary
Adverse Events	6 weeks postoperatively	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.
Patient Satisfaction (Hospital Consumer Assessment of Health Care Provider and Systems Question, HCAHPS)	6 weeks postoperatively	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?"
Pain (Visual Analogue Scale, VAS)	6 weeks postoperatively	The VAS will include a 100mm line, on which patients will be asked to rate their average pain since their surgery.
Opioid Refills	6 weeks postoperatively	As per the medication diary

Trial Locations

Locations (3)

St. Joseph's Healthcare Hamilton; 🇨🇦 Hamilton, Ontario, Canada

Hamilton General Hospital; 🇨🇦 Hamilton, Ontario, Canada

McMaster University Medical Centre; 🇨🇦 Hamilton, Ontario, Canada