Reducing Opioid Use for Chronic Pain Patients Following Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Health Network, Toronto
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥ 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
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Interventional Group
Other interventionThe 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
Other interventionPatients 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.
Treatment groups
210 Participants
are divided into 2 treatment groupsGroup A: Control GroupActive comparator 1 intervention
Group B: Interventional GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Portion of patients weaned off opioids
Opioid weaning measured by number of patients successfully weaned off opioids comparing the intervention arm versus control arm
Time frame
1 year2
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.
Time frame
One yearSponsors and contacts
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Source ClinicalTrials.gov