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

Knee Arthroscopy Clinical Trial

— NO PAin  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04566250
• Other study ID #: NOPain1111
• Status: Completed
• Phase: N/A
• Start date: February 24, 2021
• Est. completion date: April 1, 2022

Study information

• Verified date: April 2022
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: April 1, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Arthroscopy
• Shoulder Arthroscopy

Intervention

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.

Locations

Country	Name	City	State
Canada	Hamilton General Hospital	Hamilton	Ontario
Canada	McMaster University Medical Centre	Hamilton	Ontario
Canada	St. Joseph's Healthcare Hamilton	Hamilton	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
McMaster University	Hamilton Health Sciences Corporation, The Physicians' Services Incorporated Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	OMEs Prescribed	As per the medication diary	6 weeks postoperatively
Secondary	Opioid Refills	As per the medication diary	6 weeks postoperatively
Secondary	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