MedDataX Logo

Effect of a Pre-operative Internet-based Educational Video on Post Operative Opioid Consumption

NCT ID: NCT05202080

Last Updated: 2024-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-20

Study Completion Date

2025-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Patient Empowerment

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Opioid Counseling and Pain Coping Skills Video

Intervention Type OTHER

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.

Standard of Care Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Opioid Counseling and Pain Coping Skills Video

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dr. Ahtsham Niazi

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Canada

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Ahtsham U Niazi, FRCPC

Role: CONTACT

[email protected]
6473390387

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Ahtsham U Niazi, FRCPC

Role: primary

[email protected]
647-339-0387

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

5218

Identifier Type: -

Identifier Source: org_study_id