540
Participants
Start Date
November 26, 2024
Primary Completion Date
August 31, 2025
Study Completion Date
February 28, 2026
Opioid Analgesia (OA) [Multimodal analgesia including opioid drugs]
In line with current standard care, discharge prescriptions for this group will include around-the-clock non-opioid analgesics (acetaminophen and/or NSAIDs given at regularly scheduled intervals) and opioid tablets 'as needed' for breakthrough pain (i.e., pain that erupts while patients are already taking analgesics). Non-pharmacological pain interventions (i.e., icepacks, music, meditation.) may be recommended by some surgeons as part of standard practice. Given the pragmatic nature of the trial, the specific around-the-clock analgesia and rescue opioid regimens and other non-pharmacological interventions will be determined by the patient's surgeon discretion considering the breast procedure undertaken, co-morbidities, and patient preference.
Opioid-Free Analgesia (OFA) [Multimodal analgesia not including opioid drugs]
Discharge prescriptions for this group will include around-the-clock non-opioid analgesics (acetaminophen and/or NSAIDs). In case of breakthrough pain, rescue analgesia may be provided by (1) using evidence-based non-pharmacological pain interventions (i.e., icepacks, music, and meditation), (2) adding non-opioid drugs not included in the initial regimen, or (3) switching drugs targeting individual variances in analgesia response. The specific around-the-clock and rescue OFA regimens will be determined by the patient's surgeon considering the type of procedure, co-morbidities, and patient preference.
RECRUITING
McGill University Health Centre (Glen Site), Montreal
Canadian Institutes of Health Research (CIHR)
OTHER_GOV
McGill University Health Centre/Research Institute of the McGill University Health Centre
OTHER