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

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

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 Overview

• Status: Completed
• Conditions: Knee Arthroscopy; Shoulder Arthroscopy
• Intervention / Treatment: Combination product: Non-Opioid Prescription and Infographic

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8N4A6
      • St. Joseph's Healthcare Hamilton
    • Hamilton, Ontario, Canada, L8N3Z5
      • McMaster University Medical Centre
    • Hamilton, Ontario, Canada, L8N2X2
      • Hamilton General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Non-Opioid Prescription and Infographic; 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; 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.
Other: Standard of Care; The control group is standard of care, which typically includes a prescription for an opioid.	Combination product: Non-Opioid Prescription and Infographic; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: McMaster University
• Collaborators: Hamilton Health Sciences Corporation; The Physicians' Services Incorporated Foundation

Publications and helpful links

General Publications

• NO PAin Investigators; Gazendam A, Ekhtiari S, Horner NS, Simunovic N, Khan M, de Sa DL, Madden K, Ayeni OR. Effect of a Postoperative Multimodal Opioid-Sparing Protocol vs Standard Opioid Prescribing on Postoperative Opioid Consumption After Knee or Shoulder Arthroscopy: A Randomized Clinical Trial. JAMA. 2022 Oct 4;328(13):1326-1335. doi: 10.1001/jama.2022.16844. Erratum In: JAMA. 2022 Dec 13;328(22):2274.
• NO PAin Investigators. Protocol for a multicenter randomized controlled trial comparing a non-opioid prescription to the standard of care for pain control following arthroscopic knee and shoulder surgery. BMC Musculoskelet Disord. 2021 May 22;22(1):471. doi: 10.1186/s12891-021-04354-x. Erratum In: BMC Musculoskelet Disord. 2021 Jul 10;22(1):615.

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2021
• Primary Completion (Actual): April 1, 2022
• Study Completion (Actual): April 1, 2022

Study Registration Dates

• First Submitted: September 22, 2020
• First Submitted That Met QC Criteria: September 22, 2020
• First Posted (Actual): September 28, 2020

Study Record Updates

• Last Update Posted (Actual): April 5, 2022
• Last Update Submitted That Met QC Criteria: April 4, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic
• Other Study ID Numbers: NOPain1111

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No data sharing

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No