{
  "abstract": "Introduction Excessive opioid prescribing after surgery can lead to adverse events and exacerbate the opioid crisis. Patients undergoing outpatient breast surgery are often prescribed opioids to manage pain at home; however, the value of this approach is uncertain. The Postoperative Analgesia Intervention with Non-opioid Alternatives (PAIN Alt) trial will address the following research question: among patients undergoing outpatient breast surgery, does opioid-free analgesia (OFA) result in non-inferior 7-day pain intensity and pain interference in comparison to opioid analgesia (OA)?Methods and analysis This is a parallel, assessor-blind, open-label randomised trial conducted at seven university-affiliated hospitals in Canada. A sample of 540 adult patients (>18 years) undergoing outpatient mastectomy or lumpectomy will be included. Participants are allocated 1:1 to receive OA (around-the-clock non-opioids and opioids for breakthrough pain) or OFA (around-the-clock non-opioids, with adjustment of non-opioid drugs and/or non-pharmacological interventions for breakthrough pain). The co-primary outcomes are 7-day pain intensity and pain interference (measured using the Brief Pain Inventory). Secondary outcomes include adverse drug events, physical and mental health status, satisfaction with pain management, postoperative complications, chronic pain, opioid misuse, persistent opioid use, healthcare utilisation and costs. The primary statistical analyses will follow the intention-to-treat principle and be conducted using mixed-effects modelling.Ethics and dissemination This trial is coordinated by the McGill University Health Centre (ethics approval MP-37-2024-102530), with ethics approval being sought at all participating sites. Our results will be published in an open-access, peer-reviewed journal, presented at relevant conferences and disseminated to the public through press releases.Trial registration number NCT06507345.",
  "authors": [
    {
      "affiliations": [
        "Department of Surgery, McGill University, Montreal, Québec, Canada",
        "Centre for Outcomes Research and Evaluation (CORE), Research Institute of the McGill University Health Centre, Montreal, Québec, Canada",
        "Perioperative Care and Outcomes Research (PCOR) Lab, McGill University, Montreal, Québec, Canada"
      ],
      "name": "Julio F Fiore, Jr"
    },
    {
      "affiliations": [
        "Centre for Outcomes Research and Evaluation (CORE), Research Institute of the McGill University Health Centre, Montreal, Québec, Canada",
        "Perioperative Care and Outcomes Research (PCOR) Lab, McGill University, Montreal, Québec, Canada"
      ],
      "name": "Samin Shirzadi"
    },
    {
      "affiliations": [
        "Centre for Outcomes Research and Evaluation (CORE), Research Institute of the McGill University Health Centre, Montreal, Québec, Canada",
        "Perioperative Care and Outcomes Research (PCOR) Lab, McGill University, Montreal, Québec, Canada"
      ],
      "name": "Karine Roversi"
    },
    {
      "affiliations": [
        "Department of Surgery, McGill University, Montreal, Québec, Canada",
        "Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Québec, Canada"
      ],
      "name": "Ipshita Prakash"
    },
    {
      "affiliations": [
        "Department of Surgery, McGill University, Montreal, Québec, Canada",
        "Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Québec, Canada"
      ],
      "name": "Stephanie Wong"
    },
    {
      "affiliations": [
        "Department of Surgery, McGill University, Montreal, Québec, Canada"
      ],
      "name": "Sarkis Meterissian"
    },
    {
      "affiliations": [
        "Department of Surgery, McGill University, Montreal, Québec, Canada"
      ],
      "name": "Ari N Meguerditchian"
    },
    {
      "affiliations": [
        "Department of Surgery, Centre Hospitalier Universitaire de Québec, Québec, Ontario, Canada"
      ],
      "name": "Christine Desbiens"
    },
    {
      "affiliations": [
        "Department of Surgery, University of Manitoba, Winnipeg, Manitoba, Canada"
      ],
      "name": "Justin Rivard"
    },
    {
      "affiliations": [
        "Department of Surgery, University of Manitoba, Winnipeg, Manitoba, Canada"
      ],
      "name": "Megan Delisle"
    },
    {
      "affiliations": [
        "Department of Surgery, University of Ottawa, Ottawa, Ontario, Canada"
      ],
      "name": "Lisa Findlay-Shirras"
    },
    {
      "affiliations": [
        "Department of Surgery, University of Ottawa, Ottawa, Ontario, Canada"
      ],
      "name": "Jad Abou Khalil"
    },
    {
      "affiliations": [
        "Department of Surgery, London Health Sciences Centre, London, Ontario, Canada"
      ],
      "name": "Allison Maciver"
    },
    {
      "affiliations": [
        "Department of Surgery, University of Calgary Cumming School of Medicine, Calgary, Alberta, Canada"
      ],
      "name": "May Lynn Quan"
    },
    {
      "affiliations": [
        "Centre for Outcomes Research and Evaluation (CORE), Research Institute of the McGill University Health Centre, Montreal, Québec, Canada"
      ],
      "name": "Karine Verreault"
    },
    {
      "affiliations": [
        "Centre for Outcomes Research and Evaluation (CORE), Research Institute of the McGill University Health Centre, Montreal, Québec, Canada"
      ],
      "name": "Sarah Johnston"
    },
    {
      "affiliations": [
        "Department of Surgery, McGill University, Montreal, Québec, Canada",
        "Centre for Outcomes Research and Evaluation (CORE), Research Institute of the McGill University Health Centre, Montreal, Québec, Canada"
      ],
      "name": "Liane Feldman"
    },
    {
      "affiliations": [
        "Department of Medicine, McGill University, Montreal, Québec, Canada",
        "Canadian Medication Appropriateness and Deprescribing Network, Montreal, Québec, Canada"
      ],
      "name": "Emily G McDonald"
    },
    {
      "affiliations": [],
      "name": "on behalf of the Postoperative Analgesia Intervention with Non-opioid Alternatives (PAIN-Alt) Collaboration"
    }
  ],
  "title": "Comparative effectiveness of opioid versus opioid-free analgesia after outpatient breast surgery: PAIN-Alt trial protocol",
  "uid": "05178d4c-5593-5b5e-b754-07b8878fa5da"
}