Virtual Reality as a Opioid Sparing Intervention for Acute Postoperative Pain Management

摘要 每年有数以百万计的美国人接受手术，只有不到一半的患者报告说 术后疼痛缓解，约75%报告中度至重度术后疼痛。中的差距 术后疼痛处理导致阿片类药物不必要的引入和过量处方 继续加剧阿片类药物危机。美国疾病控制中心(CDC)的数据显示， 即使一天的阿片类药物治疗也可以预测患者患上阿片类药物的风险增加6% 一年内的依赖关系。AppliedVR计划将其现有的成功与基于虚拟现实(VR)的技术相结合 通过基于软件的新VR医疗提供急性围手术期疼痛管理的技术 设备，RelieVRx™。在第一阶段，我们开发了治疗性虚拟现实内容，重点是 滥用药物。RelieVRx旨在通过增强型药物预防阿片使用障碍(OUD)的发病 阿片类药物备用技术。初步临床研究表明，我们的内容降低了患者的疼痛评分 只有当患者积极使用该设备时，才会跟随治疗。在第二阶段，我们会 改进设备的功能，进行两项临床试验以验证RelieVRx™对疼痛的使用 全髋关节或膝关节置换术后的管理，并准备一份关于我们的发现的报告给FDA的2级 导弹防御系统安全许可。在目标1中，我们将优化后端基础架构(例如，存储、数据访问、交付 内容)，以改进内容存储、分发和符合™标准的数据 收集。在目标2和目标3中，我们将进行两个100名患者的试验，以评估RelieVRx对急性 与克利夫兰诊所和盖辛格合作进行全髋关节或膝关节置换术后的疼痛管理 分别是卫生系统。最后，在目标4中，我们将准备通过我们的 向食品和药物管理局提交第二类SAMD许可的从头研究。每年医疗保健支出超过130亿美元 美元用于治疗与术后疼痛管理相关的成瘾。每年估计有2.6个 数百万接受手术的人将成为阿片类药物的持续使用者。作为一种非阿片类药物替代品，旨在 减少术后疼痛，减少术后环境中阿片类药物的需求和使用， RelieVRx有望改变阿片类药物流行的进程，并极大地改善手术状态 数以百万计的患者、医生和护理人员的结果。

ABSTRACT Millions of Americans undergo surgery each year with fewer than half of patients reporting adequate postoperative pain relief and approximately 75% reporting moderate to severe postoperative pain. Gaps in postoperative pain management that lead to the unnecessary introduction and over-prescription of opioids continue to exacerbate the opioid crisis. Data from the US Center for Disease Control (CDC) revealed that even a single day of opioid therapy can predict up to a 6% increase in the risk of the patient developing a dependency within a year. appliedVR plans to combine its existing success with Virtual Reality (VR)-based technology to provide acute perioperative pain management through a new software-based VR medical device, RelieVRx™. In Phase I, we developed therapeutic virtual reality content focused on strategies for substance abuse. RelieVRx is intended to prevent the onset of Opioid Use Disorder (OUD) via enhanced opioid sparing techniques. Initial clinical studies have shown our content has reduced patient’s pain scores not only while the patient is actively utilizing the device, but also following the treatment. In Phase II, we will improve the functionality of the device, conduct two clinical trials to validate the use of RelieVRx™ for pain management after total hip or knee arthroplasty, and prepare a report of our findings to the FDA for class 2 SaMD clearance. In Aim 1, we will optimize the backend infrastructure (e.g., storage, access to data, delivery of content) of the RelieVRx™ platform to improve content storage, distribution and FDA-compliant data collection. In Aims 2 and 3, we will conduct two 100 patient trials to assess the efficacy of RelieVRx for acute pain management after total hip or knee arthroplasty in partnership with the Cleveland Clinic and Geisinger Health System, respectively. Lastly, in Aim 4, we will prepare the materials/reports garnered through our studies for a de novo submission to the FDA for class 2 SaMD clearance. Over $13 billion in annual healthcare dollars go to treating addiction associated with postoperative pain management. Annually an estimated 2.6 million people undergoing surgery will become persistent opioid users. As a non-opioid alternative intended to reduce postoperative pain and reduce the need for and utilization of opioids in the postoperative setting, RelieVRx stands to change the course of the opioid epidemic and dramatically improve the state of surgical outcomes for millions of patients, doctors, and caregivers.