5x-Multiplier vs 3-Tier Model for Discharge Opioid Prescriptions After Intra-Abdominal Cancer Surgery: Randomized Clinical Trial Protocol.

Abstract

Background: Surgeons provide up to 10% of total opioid prescriptions across all specialties, and more than one-third of surgeon-prescribed medications are opioids. Patient-reported opioid consumption and risk of persistent opioid use beyond the postoperative recovery period correlate with the initial opioid quantity prescribed at discharge. Interventions to reduce postoperative opioid prescribing have demonstrated no adverse effects on pain control or increased need for prescription refill; however, in the absence of standardized prescription protocols, opioid prescribing practices vary widely.

Objective: The study objective is to identify the opioid prescribing model that provides the lowest oral morphine equivalents (OME) volume prescribed at discharge and OME consumed in the 14 days after discharge, with no adverse effect on refills and patient quality of life or satisfaction.

Methods and analysis: This is a pragmatic single-center, multispecialty, double-arm phase II randomized clinical trial of two discharge opioid prescribing models. All adult (≥18 years) patients who undergo any one of five open abdominal oncologic operations (pancreatectomy, hepatectomy, retroperitoneal sarcoma resection, nephrectomy, or cytoreductive surgery for ovarian cancer) with curative intent and have a planned postoperative inpatient stay of at least 48 hours will be eligible. Patients will be stratified by their managing clinical service and randomized to receive a discharge opioid prescription based on either the 5x-multiplier algorithm or the 3-tier model. The co-primary outcomes are initial discharge OME volume and OME consumption in the 14 days after hospital discharge. Secondary outcomes include rates of patients with zero OME at discharge; rates of refill requests and completions, number of unused or leftover pills, persistent opioid use, and patient-reported quality-of-life metrics at various follow-up times; patient, prescriber, and oncologic factors predictive of persistent opioid use; and patient satisfaction. Each co-primary endpoint will be analyzed using two-sample t-test to compare means and linear regression models to assess differences between the two arms.

Ethics and dissemination: This study was approved by the Institutional Review Board of The University of Texas MD Anderson Cancer Center (2023-0818). The study will evaluate the difference in initial discharge OME volume and in 14-day post-discharge OME consumption between two discharge opioid prescribing models. Upon completion of the data collection and analyses, a manuscript describing the study results will be submitted to a peer-reviewed journal for publication and dissemination. Trial Registration Number: NCT06232577.