Fields Brittany C, Newhook Timothy E, Lillemoe Heather A, Qiao Wei, Karam Jose A, Matin Surena F, Meyer Larissa A, Tzeng Ching-Wei D
Department of Surgical Oncology, The University of Texas MD Anderson Cancer Center.
Department of Breast Surgical Oncology, The University of Texas MD Anderson Cancer Center.
Adv Cancer Educ Qual Improv. 2025;1(1). doi: 10.52519/aceqi.25.1.1.a19.
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.
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.
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.
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.
在所有专科中，外科医生开出的阿片类药物处方占总处方量的比例高达10%，且外科医生开出的药物中超过三分之一为阿片类药物。患者报告的阿片类药物消费量以及术后恢复期后持续使用阿片类药物的风险与出院时最初开具的阿片类药物数量相关。减少术后阿片类药物处方的干预措施已证明对疼痛控制无不良影响，也未增加处方 refill 的需求；然而，在缺乏标准化处方方案的情况下，阿片类药物的处方做法差异很大。
本研究的目的是确定能在出院时开出最低口服吗啡当量（OME）量且在出院后14天内消耗最低OME量的阿片类药物处方模式，同时对 refill 和患者生活质量或满意度无不良影响。
这是一项针对两种出院阿片类药物处方模式的务实单中心、多专科、双臂II期随机临床试验。所有成年（≥18岁）患者，若接受五种有治愈意图的开放性腹部肿瘤手术（胰十二指肠切除术、肝切除术、腹膜后肉瘤切除术、肾切除术或卵巢癌肿瘤细胞减灭术）中的任何一种，且术后计划住院至少48小时，均符合条件。患者将按其管理临床服务进行分层，并随机接受基于5倍乘数算法或3层模型的出院阿片类药物处方。共同主要结局是初始出院时的OME量和出院后14天内的OME消费量。次要结局包括出院时OME为零的患者比例；refill 请求和完成率、未使用或剩余药丸数量、持续使用阿片类药物情况以及在不同随访时间患者报告的生活质量指标；预测持续使用阿片类药物的患者、开处方者和肿瘤学因素；以及患者满意度。每个共同主要终点将使用两样本t检验分析以比较均值，并使用线性回归模型评估两组之间的差异。
本研究已获得德克萨斯大学MD安德森癌症中心机构审查委员会的批准（2023 - 0818）。该研究将评估两种出院阿片类药物处方模式在初始出院时OME量和出院后14天内OME消费量方面的差异。在完成数据收集和分析后，将提交一份描述研究结果的手稿给同行评审期刊发表和传播。试验注册号：NCT06232577。
