Recruiting

Opioid Reduction

Sponsor:

University Health Network, Toronto

Code:

NCT03675386

Conditions

Chronic Pain

Opioid Use

Postoperative Pain

Opioid Dependence

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Interventional Group

Control Intervention

Study Details

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

Study ID

NCT03675386

Start date

Oct 15, 2018

Status verified date

Apr, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • ≥ 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

Exclusion Criteria:

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

Study Design

Enrollment

210 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

active comparator: Control Group

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.

experimental: Interventional Group

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.

Interventions

Interventional Group

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.

Control Intervention

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.

Primary outcome measure

  • Portion of patients weaned off opioids [ Time Frame: 1 year ]
  • Pain interference [ Time Frame: One year ]

Central Contacts and Locations

Central contacts

Karim Ladha, MD

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

Hance Clarke, MD, PhD

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

Locations

Toronto General Hospital- University Health Network

Recruiting

Toronto, Ontario, Canada, M5G 2N2

Contacts

Karim Ladha, MD

(416) 719-0030karim.ladha@uhn.ca

Hance Clarke, MD, PhD

(416) 340-4800hance.clarke@uhn.ca

Principal Investigator:

Elaheh Adly, MD

More Information

Sponsor

University Health Network, Toronto

Last update posted

Apr 30, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2026-04-30.