Integrating Tailored Postoperative Opioid Tapering and Pain Management Support for Patients on Long-Term Opioid Use Presenting for Spine Surgery (MIRHIQL)

摘要 每年有5100万美国人接受手术，其中10%-20%的人长期使用阿片类药物 (LTOU)远远超过全国流行率。这些服用LTOU的患者面临着压倒性的风险增加 术后并发症、发病率、死亡率、疼痛增加、持续的术后LTOU和阿片类药物- 相关伤害。手术是LTOU患者的关键护理要点，因为阿片类药物的处方不管 以前有问题的阿片类药物使用，阿片类药物在长时间内急剧增加，与阿片类药物相关 危害，患者面临着无数负面的术后结果的高风险 影响生活质量。术后阿片类药物逐渐减少与非阿片类急性疼痛处理的研究 通常将这些脆弱的患者排除在外。我们的建议解决了这一严重的知识鸿沟 LTOU患者术后慢性疼痛护理。患者接受疼痛治疗的变化，并 术后阿片类药物逐渐减少，这是一个关键的干预机会。此外，还需要更安全的替代方案来 降低与某些常见非阿片类药物同时使用相关的呼吸抑制的严重风险 以及阿片类止痛药。这项建议建立在PI的研究(K23，R01)术后发展的基础上 激励性访谈和指导阿片类药物逐渐减少支持(MI-阿片类药物逐渐减少)并论证可行性 和最初的经验性支持促进术后阿片类药物的停止，甚至不会对疼痛产生不利影响 在术前使用阿片类药物的患者中。替扎尼定具有止痛、肌肉松弛、抗焦虑和阿片类药物- 节省效应，并有可能缓解阿片类药物戒断症状作为2-激动剂。我们直接针对 通过检测MI-阿片类药物减量(行为)和替扎尼定的联合效应来治疗MIRHIQL主动性 对术前LTOU患者恢复到基线有障碍的(药理学)干预 手术后使用阿片类药物的危害可能超过继续使用的好处。在这个类型1的混合体中 375例术前LTOU脊柱手术患者实施三臂平行RCT的效果 外科手术将在4个地点(斯坦福大学、哈佛大学、维克森林大学、堪萨斯大学)招募，并随机分配到1个 3组(MI-阿片类药物减量和替扎尼定，MI-阿片类药物减量和安慰剂，加强日常护理)并随访 已经12个月了。主要结果是阿片类药物使用基线的时间。次要结果是服用阿片类药物的时间 停止、阿片类药物分配停止、疼痛停止以及术后阿片类药物滥用的风险。我们会 检查改变的动机、改变的谈话和减轻疼痛作为治疗效果和 在预测治疗参与度和参与者属性时，表征治疗交互作用 功效。使用RE-AIM框架的混合方法评估将探索障碍和促进者 未来将更大规模地实施MI-阿片类药物缩减。该项目将解决未得到满足的患者的需求 需要精确的术后疼痛护理以最大限度地减少阿片类药物相关伤害的LTOU。

Abstract 51 million Americans undergo surgery annually and 10-20% present for surgery with long-term opioid use (LTOU) far exceeding the national prevalence. These patients on LTOU are at overwhelmingly increased risk of postoperative complications, morbidity, mortality, increased pain, persistent postoperative LTOU, and opioid- related harms. Surgery is a critical point-of-care for patients with LTOU as opioids are prescribed regardless of prior problematic opioid use, opioids are acutely escalated for prolonged durations compounded opioid-related harms, and patients are at heightened risk for a myriad of negative postoperative outcomes adversely impacting QOL. Research examining postoperative opioid tapering and non-opioid acute pain management often excludes these vulnerable patients. Our proposal addresses this critical knowledge gap in acute to chronic postoperative pain care for patients with LTOU. Patients are receptive to changes in pain therapy and opioid tapering after surgery, representing a key intervention opportunity. Also, safer alternatives are needed to reduce serious risks of respiratory depression associated with concomitant use of certain common non-opioid and opioid pain medications. This proposal builds off the PI’s research (K23, R01) developing postoperative Motivational Interviewing and guided Opioid Tapering support (MI-Opioid Taper) and demonstrating feasibility and initial empiric support in promoting postoperative opioid cessation without adversely affecting pain even among patients with preoperative opioid use. Tizanidine has analgesic, muscle relaxant, anxiolytic and opioid- sparing effects, and potential to relieve opioid withdrawal symptoms as an 2-agonist. We directly address the HEAL MIRHIQL initiative by examining the combined effects of MI-Opioid Taper (behavioral) and tizanidine (pharmacologic) interventions among patients with preoperative LTOU exhibiting impaired return to baseline opioid use after surgery where harms may outweigh benefits of continued use. In this Type 1 hybrid effectiveness-implementation three-arm parallel RCT, 375 patients with preoperative LTOU undergoing spine surgery will be recruited across 4 sites (Stanford, Harvard, Wake Forest, U. of Kansas) and randomized to 1 of 3 groups (MI-Opioid Taper and tizanidine, MI-Opioid Taper and placebo, enhanced usual care) and followed for 12 months. The primary outcome is time to baseline opioid use. Secondary outcomes are time to opioid cessation, opioid dispensing cessation, pain cessation, and risk of postoperative opioid misuse. We will examine motivation for change, change talk, and reduction in pain as mediators of treatment effects and characterize treatment interactions with participant attributes in predicting both treatment engagement and efficacy. A mixed-methods evaluation using the RE-AIM framework will explore barriers and facilitators to future larger-scale implementation of MI-Opioid Taper. The project will address the unmet needs of patients on LTOU presenting for surgery in need of precision postoperative pain care to minimize opioid-related harms.