NCT05202080

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
1mo left

Started Sep 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress98%
Sep 2022Jun 2026

First Submitted

Initial submission to the registry

January 7, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 21, 2022

Completed
8 months until next milestone

Study Start

First participant enrolled

September 20, 2022

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

March 12, 2026

Status Verified

March 1, 2026

Enrollment Period

3.7 years

First QC Date

January 7, 2022

Last Update Submit

March 10, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Post operative opioid consumption

    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 Outcomes (10)

  • Postoperative Pain

    On postoperative days 1/2/3, and 1- and 6-week follow-up.

  • Length of hospital stay

    From day of admission until 72 hours postoperatively.

  • Time to first opioid demand dose

    In the first 24 hours after surgery.

  • Post-operative complication rate

    24 hours after surgery, and 1/6 week follow-ups.

  • Total opioid consumption at 6-week follow-up

    6 weeks after surgery.

  • +5 more secondary outcomes

Study Arms (2)

Opioid Counseling and PCS Video Group

EXPERIMENTAL

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.

Other: Opioid Counseling and Pain Coping Skills Video

Standard of Care Group

NO INTERVENTION

This arm of the study will the conventional information provided to all patients undergoing total joint arthroplasty.

Interventions

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.

Opioid Counseling and PCS Video Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Patient Participation

Condition Hierarchy (Ancestors)

Patient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 7, 2022

First Posted

January 21, 2022

Study Start

September 20, 2022

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

March 12, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations