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

Patient Empowerment Clinical Trial

Official title:

Effect of a Pre-operative Internet-based Educational Video, Providing Both Opioid Counselling and Pain Coping Skills, on Post-operative Opioid Consumption

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05202080
• Other study ID #: 5218
• Status: Recruiting
• Phase: N/A
• Start date: September 20, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: November 2023
• Source: Sunnybrook Health Sciences Centre
• Contact: Ahtsham U Niazi, FRCPC
• Phone: 6473390387
• Email: ahtsham.niazi[@]sunnybrook.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Patient Empowerment

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post operative opioid consumption	opioid tablets used in the 2 weeks post operatively	2 weeks postoperatively
Secondary	Postoperative Pain	Using the Verbal Analog Scale (VAS) for Pain Assessment from 0 to 10 with 0 being no pain and 10 being extreme pain.	72 hours post operatively