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Completed

NCT Number: NCT04566250

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

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.

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Key information

Conditions

Knee Arthroscopy Shoulder Arthroscopy

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hamilton General Hospital, Hamilton, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Patients aged 18 years and older
  • Patients who have the ability to speak, understand, and read English
  • Provision of informed consent

Exclusion criteria

  • Patients who take or are on a home dose of an opioid medication (i.e. once daily or more)
  • Patients involved in ongoing litigation or compensation claims for any injury (e.g. Work Safety Insurance Board, WSIB)
  • Patients involved in another research study that requires a specific post-operative pain control medication regimen
  • Patients undergoing a knee or shoulder arthroscopy procedure that will likely have an operative time greater than 3 hours
  • Patients who will undergo concomitant open surgery
  • Patients who require overnight admission
  • Patients with a contraindication or allergy to NSAIDs, acetaminophen, or morphine and hydromorphone
  • Patients diagnosed with renal disease or cardiac disease
  • Patients who are scheduled for/plan to have an additional surgical procedure during the 6-week follow-up period
  • Patients who will likely have problems, in the judgement of the investigator, with maintaining follow-up
  • Any other reason(s) the investigator feels is relevant for excluding the patient

Treatment and study plan

Non-Opioid Prescription and Infographic

Combination Product

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.

Primary outcomes

  1. Total oral morphine equivalents (OMEs)

    Time frame: 6 weeks postoperatively

    The primary outcome is the number of total OMEs consumed as determined by a patient-reported medication diary.

Secondary outcomes

  1. Pain (Visual Analogue Scale, VAS)

    Time frame: 6 weeks postoperatively

    The VAS will include a 100mm line, on which patients will be asked to rate their average pain since their surgery.

  2. Patient Satisfaction (Hospital Consumer Assessment of Health Care Provider and Systems Question, HCAHPS)

    Time frame: 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?"

  3. OMEs Prescribed

    Time frame: 6 weeks postoperatively

    As per the medication diary

  4. Opioid Refills

    Time frame: 6 weeks postoperatively

    As per the medication diary

  5. Adverse Events

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Collaborators

  • Hamilton Health Sciences Corporation
  • The Physicians' Services Incorporated Foundation

Registry information

Official study title

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

Acronym: NO PAin

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 28, 2020
Registry last updated
Nov 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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