Reducing Opioid Use for Chronic Pain Patients Following Surgery

NCT03675386 | Recruiting

• 1 other identifier: 18-5207
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with chronic pain are often prescribed long-term opioid therapy, despite the serious risks and growing concerns related to opioid use. The Toronto General Hospital has created the world's first multidisciplinary perioperative Transitional Pain Service Program (TPSP) aimed at reducing the incidence and severity of chronic post-surgical pain. The TPSP incorporates a variety of mechanisms and interventions to help patients manage pain and to wean off opioids. The approach consists of: pain education, Acceptance and Commitment Therapy (ACT), and an e-mobile self- management tool to help patients manage chronic pain more effectively. With the TPSP team, the investigators hope to continually assist patients to achieve a balance between the benefits and potential harms of opioid use to promote long-term health and well-being.

Conditions

Chronic Pain; Opioid Use; Postoperative Pain; Opioid Dependence

Outcome Measures

Primary Outcomes (2)

• Portion of patients weaned off opioids

  Opioid weaning measured by number of patients successfully weaned off opioids comparing the intervention arm versus control arm

  1 year

• Pain interference

  Brief Pain Inventory Scale is a measure that assess the severity of pain and the impact of pain on daily functions. Measurement of this scale is rated on a 0-10 numerical-rating-scale ( 0= No Pain to 10= Pain as bad as you can imagine or 0= Does not interfere to 10= Completely interferes). The BPI assess pain at its worst, least, average, and now. Pain Severity Score is calculated by adding the scores for questions 2, 3, 4 and 5 and then dividing by 4. This gives a severity score out of 10. Pain Interference Score is calculated by adding the scores for questions 8a, b, c, d, e, f and g and then dividing by 7. This gives an interference score out of 10.

  One year

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Patients in the control group will receive standard care, which involves standard postoperative follow-up with their surgeon/primary care provider. Patients will also be sent with a link for an online multimedia tool during each follow-up time point that will provide information and education regarding non-pharmacologic techniques for managing pain. At the end, all patients in the control arm will be invited to join the TPSP after one year of follow-up if they are still taking opioids.

Other: Control Intervention

Interventional Group

EXPERIMENTAL

Patients in the interventional group will be given a Transitional Pain Service follow-up appointment at the following postoperative time points (2 to 6 visits for the first two months, and then 1 to 2 visits on a monthly basis until one year). At each visit, patients will meet with the clinical psychologist and chronic pain specialist. Patients in the intervention group will have access to the Manage My Pain (MMP) App. which allows people living with pain to quickly and easily track their pain and function on a daily basis on their smartphones or a browser on their desktop or mobile device. One-page clinical reports will capture the changes in patients' outcome data between clinical visits over the course in time.Clinic visits can be offered in person at the hospital or over telehealth (video conference) based on the patient's preference and clinician's judgment for telehealth suitability.

Other: Interventional Group

Interventions

Interventional Group OTHER

The Transitional Pain Service Program enables targeted, mechanism-based, treatment innovations aimed at reducing the incidence and severity of chronic post-surgical pain, disability and enabling safe opioid prescribing/ weaning after major surgery. The investigator's TPSP intervention uses a variety of methods to support patients to manage pain and wean off opioids. This includes physician-guided opioid and non-opioid pharmacotherapy and tapering, and clinical psychology services specializing in pain education, Acceptance \& Commitment Therapy (ACT) and e-mobile self-management tools.

Also known as: Transitional Pain Service Program

Interventional Group

Control Intervention OTHER

Patients in the control group will receive standard care, which involves standard postoperative follow-up with their surgeon/primary care provider. Patients will also be sent with a link for an online multimedia tool during each follow-up time point that will provide information and education regarding non-pharmacologic techniques for managing pain. At the end, all patients in the control arm will be invited to join the TPSP after one year of follow-up if they are still taking opioids.

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 18 years of age
• Taking 10 -- 400 mg of preoperative oral morphine equivalents daily
• Any type of surgical procedure, with the exception of those with palliative intent or organ transplantation
• Able to read and understand English as posed on the questionnaire surveys prior to informed consent
• Must be taking opioids for at least one month prior to their operation
• Must have a personal email address for the set-up of the Manage My Pain (MMP) App or online multimedia tool

You may not qualify if:

• Subjects who are undergoing palliative care or procedures, organ transplantation, or prescribed with Methadone/Buprenorphine will be excluded from the trial

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto General Hospital- University Health Network

Toronto, Ontario, M5G 2N2, Canada

RECRUITING

Related Publications (17)

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MeSH Terms

Conditions

Chronic Pain; Pain, Postoperative; Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Karim Ladha, MD

  Toronto General Hospital, University Health Network

  PRINCIPAL INVESTIGATOR

• Hance Clarke, MD, PhD

  Toronto General Hospital, University Health Network

  PRINCIPAL INVESTIGATOR

• Elaheh Adly, MD

  Hamilton Health Sciences Centre

  PRINCIPAL INVESTIGATOR

• Paul Tumber, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

• Anton Marinov, MD

  Rouge Valley Medical Centre

  PRINCIPAL INVESTIGATOR

• Melanie Toman, MD

  Thunder Bay Reginal Health Sciences Centre

  PRINCIPAL INVESTIGATOR

• Yuvaraj Kotteeswaran, MD

  Thunder Bay Reginal Health Sciences Centre

  PRINCIPAL INVESTIGATOR

• Duminda Wijeysundera, MD

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karim Ladha, MD

CONTACT

416-719-0030; Karim.Ladha@uhn.ca

Hance Clarke, MD, PhD

CONTACT

416-340-4800; Hance.Clarke@uhn.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2018
• First Posted: September 18, 2018
• Study Start: October 15, 2018
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)