Postoperative Analgesia Intervention With Non-opioid Alternatives (PAIN-Alt) Trial - Breast Surgery

NARecruitingINTERVENTIONAL
Enrollment

540

Participants

Timeline

Start Date

November 26, 2024

Primary Completion Date

August 31, 2025

Study Completion Date

February 28, 2026

Conditions
Post Operative PainOpioid Analgesic Adverse ReactionSurgeryPostoperative PainBreast Disease
Interventions
OTHER

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.

OTHER

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.

Trial Locations (1)

H4A 3J1

RECRUITING

McGill University Health Centre (Glen Site), Montreal

All Listed Sponsors
collaborator

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

lead

McGill University Health Centre/Research Institute of the McGill University Health Centre

OTHER