- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05202080
Effect of a Pre-operative Internet-based Educational Video on Post Operative Opioid Consumption
March 10, 2026 updated by: Dr. Ahtsham Niazi, Sunnybrook Health Sciences Centre
Effect of a Pre-operative Internet-based Educational Video, Providing Both Opioid Counselling and Pain Coping Skills, on Post-operative Opioid Consumption
One of the most challenging issues in modern medicine is the current opioid epidemic.
Given the association between opioid use after surgery and the development of opioid addiction, an essential goal of the medical community should be to develop strategies aimed at instructing the safe use of opioids.
In addition, instructions on how to use non-opioid painkillers and exercises and techniques to better cope with pain can be used to reduce the patients opioid requirements after surgery.
This study aims to evaluate the effect of providing an online educational video presentation to patients prior to surgery.
This will be a 30 minute video which will provide the study participants with instructions on how best to use their opioid and non-opioid medication for pain and also teach the study participants exercises and techniques to better cope with their pain.
This intervention will be used with a view to reduce the amount of opioids used by patients following hip or knee replacement surgery.
Participants will be followed during their immediate phase after surgery to determine how much pain killers the participants have used and at six weeks the participants will be asked to return their unused opioids to see how much the participants have used in total.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
220
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M4N 3M5
- Sunnybrook Health Sciences Centre
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patients must be adults (> 18 years of age) undergoing knee or hip arthroplasty.
- Patients will be ASA 1-3 undergoing elective surgery.
- English speaking patients with internet and computer access at home will be included.
- Patients with pre-existing psychological conditions who receive either pharmaceutical or talk-based therapy will be included.
- Patients must meet a minimum cognitive capacity to understand the instructions for the Opioid Counseling and Pain Coping Skills presentation. This will be assessed by the administration of the Montreal Cognitive Assessment during screening (MoCA), whereby a minimum score of 18 will be required to meet inclusion into the study.
Exclusion Criteria:
- Significant cognitive impairment.
- Chronic pain, long-term opioid therapy
- Renal replacement therapy
- Standing opioid requirements
- Neuropathic pain
- Fractures requiring emergency surgery
- End stage cardiac or respiratory disease
- Severe hepatic dysfunction,
- Patients with severe psychiatric disorders
- Vision loss
- Allergy to local anesthesia.
- Patients who refuse to consent to neuraxial anesthesia and/or peripheral nerve blocks will also be excluded.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Opioid Counseling and PCS Video Group
This arm of the study will receive the opioid counseling and pain coping skills video 2 weeks prior to their surgery in addition to the conventional information provided to all patients undergoing total joint arthroplasty.
|
The intervention will be in the form of a video of a PowerPoint presentation with instructions and exercises designed to coach patients about catastrophizing, coping skills, mindfulness and behavioral modification techniques, in addition to providing education regarding postoperative analgesia and opioid use.
|
|
No Intervention: Standard of Care Group
This arm of the study will the conventional information provided to all patients undergoing total joint arthroplasty.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Post operative opioid consumption
Time Frame: From surgery until 72 hours postoperatively.
|
Total opioid consumption during the first 72 hours following THA or TKA surgery, measured in oral morphine equivalents.
|
From surgery until 72 hours postoperatively.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative Pain
Time Frame: On postoperative days 1/2/3, and 1- and 6-week follow-up.
|
Using the Visual Analog Scale (VAS) for Pain Assessment from 0 to 10 with 0 being no pain and 10 being extreme pain.
|
On postoperative days 1/2/3, and 1- and 6-week follow-up.
|
|
Length of hospital stay
Time Frame: From day of admission until 72 hours postoperatively.
|
Length of Stay from day of hospital admission to day of hospital discharge.
|
From day of admission until 72 hours postoperatively.
|
|
Time to first opioid demand dose
Time Frame: In the first 24 hours after surgery.
|
The number of hours from the time of surgery to the participants requesting their first opioid dose, either in the post-anesthesia care unit or the ward.
|
In the first 24 hours after surgery.
|
|
Post-operative complication rate
Time Frame: 24 hours after surgery, and 1/6 week follow-ups.
|
The incidence of postoperative complications, including events possibly related to opioid consumption.
|
24 hours after surgery, and 1/6 week follow-ups.
|
|
Total opioid consumption at 6-week follow-up
Time Frame: 6 weeks after surgery.
|
The total opioid consumption, reported at the 6 week follow-up.
|
6 weeks after surgery.
|
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Need for rescue opioid breakthrough therapy
Time Frame: From surgery until 24 hours postoperatively.
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The need for rescue opioid breakthrough therapy in the first 24 hours after surgery, assessed as a binary (yes/no) outcome.
|
From surgery until 24 hours postoperatively.
|
|
Participant Compliance
Time Frame: Day of surgery
|
Participant compliance, defined as whether or not participants in the experimental group viewed the study video.
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Day of surgery
|
|
Participant satisfaction at baseline
Time Frame: Baseline (up to 1 week before surgery).
|
Participants' satisfaction with the study video, assessed using a questionnaire.
The questionnaire contains seven statements regarding the acceptability of the study video, with responses on a 5-point Likert scale from "highly agree" to "highly disagree."
Only participants in the experimental group complete the satisfaction questionnaire.
|
Baseline (up to 1 week before surgery).
|
|
Participant satisfaction at 1 week
Time Frame: 1 week after surgery.
|
Participants' satisfaction with the study video, assessed using a questionnaire.
The questionnaire contains seven statements regarding the acceptability of the study video, with responses on a 5-point Likert scale from "highly agree" to "highly disagree."
Only participants in the experimental group complete the satisfaction questionnaire.
|
1 week after surgery.
|
|
Participant satisfaction at 6 weeks
Time Frame: 6 weeks after surgery.
|
Participants' satisfaction with the study video, assessed using a questionnaire.
The questionnaire contains seven statements regarding the acceptability of the study video, with responses on a 5-point Likert scale from "highly agree" to "highly disagree."
Only participants in the experimental group complete the satisfaction questionnaire.
|
6 weeks after surgery.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 20, 2022
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
June 1, 2026
Study Registration Dates
First Submitted
January 7, 2022
First Submitted That Met QC Criteria
January 7, 2022
First Posted (Actual)
January 21, 2022
Study Record Updates
Last Update Posted (Actual)
March 12, 2026
Last Update Submitted That Met QC Criteria
March 10, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5218
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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