Evidence map›Paper›PMID 41193191›Full record

ArticleBMJ open2025

Comparative effectiveness of opioid versus opioid-free analgesia after outpatient breast surgery: PAIN-Alt trial protocol.

Julio F Fiore, Samin Shirzadi, Karine Roversi, Ipshita Prakash, Stephanie Wong, Sarkis Meterissian, Ari N Meguerditchian, Christine Desbiens, Justin Rivard, Megan Delisle and 9 more

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMJ open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06507345 (Comparative Effectiveness of Opioid Versus Opioid-free Post-discharge Analgesia After Outpatient Breast Surgery), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06507345 narecruitingnot on this map

Comparative Effectiveness of Opioid Versus Opioid-free Post-discharge Analgesia After Outpatient Breast Surgery: A Protocol for a Randomized Controlled Trial (PAIN-Alt Trial)

TypeinterventionalSponsorMcGill University Health Centre/Research Institute of the McGill University Health CentreRan2024 to 2026Enrolled540ConditionsPost Operative Pain, Opioid Analgesic Adverse Reaction, Surgery, Postoperative PainArmsOpioid Analgesia (OA) [Multimodal analgesia including opioid drugs], Opioid-Free Analgesia (OFA) [Multimodal analgesia not including opioid drugs]
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

19 authors.

Julio F FioreDepartment of Surgery, McGill University, Montreal, Québec, Canada julio.fiorejunior@mcgill.ca.ORCID http://orcid.org/0000-0002-0019-8673
Samin ShirzadiCentre for Outcomes Research and Evaluation (CORE), Research Institute of the McGill University Health Centre, Montreal, Québec, Canada.ORCID http://orcid.org/0000-0001-7926-1171
Karine RoversiCentre for Outcomes Research and Evaluation (CORE), Research Institute of the McGill University Health Centre, Montreal, Québec, Canada.
Ipshita PrakashDepartment of Surgery, McGill University, Montreal, Québec, Canada.
Stephanie WongDepartment of Surgery, McGill University, Montreal, Québec, Canada.
Sarkis MeterissianDepartment of Surgery, McGill University, Montreal, Québec, Canada.
Ari N MeguerditchianDepartment of Surgery, McGill University, Montreal, Québec, Canada.
Christine DesbiensDepartment of Surgery, Centre Hospitalier Universitaire de Québec, Québec, Ontario, Canada.
Justin RivardDepartment of Surgery, University of Manitoba, Winnipeg, Manitoba, Canada.
Megan DelisleDepartment of Surgery, University of Manitoba, Winnipeg, Manitoba, Canada.ORCID http://orcid.org/0009-0008-9419-8957
Lisa Findlay-ShirrasDepartment of Surgery, University of Ottawa, Ottawa, Ontario, Canada.
Jad Abou KhalilDepartment of Surgery, University of Ottawa, Ottawa, Ontario, Canada.
Allison MaciverDepartment of Surgery, London Health Sciences Centre, London, Ontario, Canada.
May Lynn QuanDepartment of Surgery, University of Calgary Cumming School of Medicine, Calgary, Alberta, Canada.ORCID http://orcid.org/0000-0003-2603-0411
Karine VerreaultCentre for Outcomes Research and Evaluation (CORE), Research Institute of the McGill University Health Centre, Montreal, Québec, Canada.
Sarah JohnstonCentre for Outcomes Research and Evaluation (CORE), Research Institute of the McGill University Health Centre, Montreal, Québec, Canada.
Liane FeldmanDepartment of Surgery, McGill University, Montreal, Québec, Canada.
Emily G McDonaldDepartment of Medicine, McGill University, Montreal, Québec, Canada.ORCID http://orcid.org/0000-0003-0783-0624
Postoperative Analgesia Intervention with Non-opioid Alternatives (PAIN-Alt) Collaboration

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionExcessive 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.

Indexed as

Ambulatory Surgical ProceduresAnalgesics, Non-NarcoticAnalgesics, OpioidMastectomyPain ManagementPostoperative PainAdultBreast NeoplasmsCanadaFemaleHumansPain MeasurementRandomized Controlled Trials as TopicAnalgesics, Non-NarcoticAnalgesics, OpioidBreast surgeryPain managementPatient-Centered CareSURGERY

Identifiers

PMID41193191
PMCPMC12588022

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.