Prospective Preference Assessment of Potential Participants in the Perioperative Rectal Methadone in Spine Surgery (PROMISE) Trial.

Authors

Victoria Tucci, Mindy Lu, Nandana Parakh, Janneth Pazmino-Canizares, Roshni Nayar, Zaaria Thomas, Gabriella Mattina, Christopher D Witiw, Jefferson Wilson, Karim Ladha, Duminda Wijeysundera, Akash Goel, Sérgio Martins Pereira

Published in

Canadian journal of pain = Revue canadienne de la douleur. Volume 10. Issue 1. Pages 2717112. Epub Oct 01, 2026.

Abstract

Perioperative pain management in spine surgery is challenging, with many patients suffering from chronic pain. The favorable pharmacokinetic-dynamic profile of methadone may offer a novel approach to perioperative analgesia; however, stigma around methadone and rectal administration may bias patient enrollment. Before initiating a trial comparing rectal methadone to placebo, we conducted a prospective preference assessment (PPA) to identify barriers and motivators for participation and characterize differences between willing and unwilling participants to refine the trial protocol.
Adult patients undergoing elective spinal surgery were recruited from St. Michael's Hospital's preoperative clinic from July to August 2024. Participants completed a PPA, including a trial vignette, assessment of understanding, open-ended questions exploring attitudes toward the trial, and a questionnaire. Data were analyzed with thematic analysis, t-test, and Fisher's exact test.
Thirty participants were enrolled and categorized based on a 6-point Likert scale into "willing" to participate (Likert 4-6, 83.3%, CI 0.69-0.98) and "not willing" (Likert 1-3, 16.7%, CI 0.0-0.49). Pain as a major concern was significantly associated with willingness to participate, with 88% of willing participants reporting it as a concern compared to 40% of non-willing participants (p = .04). Common motivators included optimizing pain management (57%) and perceived benefits of rectal methadone (30%). Common concerns were methadone side effects (13%) and dependency fears (13%).
We identified a strong willingness (83.3%, CI 0.69-0.98) among spine surgery patients to participate in our trial. Protocol adjustments will focus on patient education regarding methadone's safety profile, clarifying measures to minimize dependency risks, and ensuring physiologic monitoring.

PMID:
42840816
Bibliographic data and abstract were imported from PubMed on 07 Oct 2026.

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