Clinical trial NCT04566250: Non-Opioid Prescriptions After Arthroscopic Surgery in Canada (NO PAin)
Official title: Non-Opioid Prescriptions After Arthroscopic Surgery in Canada (NO PAin): a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Arthroscopy
Shoulder Arthroscopy
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Hamilton Health Sciences Corporation
name: The Physicians' Services Incorporated Foundation
First posted: 2020-09-28
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Eligible patients will be randomized using the centralized 24-hour computerized randomization system to allocate patients to the control (standard of care) or intervention (non-opioid prescription and infographic) group.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Total oral morphine equivalents (OMEs)
timeFrame: 6 weeks postoperatively
Secondary outcomes:
measure: Pain (Visual Analogue Scale, VAS)
timeFrame: 6 weeks postoperatively
measure: Patient Satisfaction (Hospital Consumer Assessment of Health Care Provider and Systems Question, HCAHPS)
timeFrame: 6 weeks postoperatively
measure: OMEs Prescribed
timeFrame: 6 weeks postoperatively
measure: Opioid Refills
timeFrame: 6 weeks postoperatively
measure: Adverse Events
timeFrame: 6 weeks postoperatively
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton General Hospital
state: Ontario
city: Hamilton
country: Canada
facility: McMaster University Medical Centre
state: Ontario
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare Hamilton
state: Ontario
Study officials:
References:
citation: 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.
citation: 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.