Reduction of opioid requirement associated with Auriculo-nerve stimulation following open surgery

项目总结：阿片类药物的围手术期处方是目前阿片类药物的重要贡献者 流行病，每年影响超过5000万接受手术的美国人中的约4%。的剂量和持续时间 手术患者接受阿片类药物治疗是阿片类药物使用障碍和过量死亡的既定风险因素。 虽然已经制定了立法和指导方针来限制阿片类药物的处方量， 在美国，2020年阿片类药物过量死亡人数增加了39%， 在COVID-19背景下的健康和阿片类药物使用障碍。开发替代和有效的外科手术 镇痛和避免或尽量减少围手术期阿片类药物使用和阿片类药物使用障碍的技术至关重要 在当前阿片类药物流行的斗争中。耳穴疗法，一种针灸，是一种有效的阿片类药物节省， 替代治疗疼痛。使用传统的耳穴疗法是有限的，因为长期和具体的训练， 要求。最近，一种新型的电池供电的一次性耳神经场刺激器，NSS-2桥， Device®（NBD®）的开发旨在克服传统耳道疗法的局限性。NBD®是一种 刺激颅神经和支配颈浅丛分支的一次性器械 耳朵该设备已被FDA批准用于治疗阿片类药物戒断症状，包括腹部 痛苦和焦虑NBD®需要最少的训练，并允许刺激耳神经5天 使NBD®成为限制阿片类药物使用和处方的潜在突破性非药理学方法。 啮齿类动物研究支持NBD调节疼痛通路和减少炎症性腹部疼痛。 痛苦我们的人类手术疼痛试点数据支持NBD®可有效减少术后阿片类药物 接受开放性手术的成人，特别是脆弱的老年患者（>65岁）的要求。我们的中央 假设与安慰剂相比，NBD®将是患者有效的阿片类药物节省工具 接受开放手术，NBD的有效性将在脆弱的老年患者中更大 (age 65年）。因为，焦虑，抑郁和灾难性的增加术后疼痛和阿片类药物 要求高达50%，因为耳穴疗法减少了心理症状，我们还假设 使用NBD®也将减少焦虑，抑郁和灾难化，这代表了一种机制， NBD®减少围手术期阿片类药物的需求。我们的多学科团队能够很好地测试 以下具体目标：1）量化NBD®在易受伤害的开放手术后的阿片样物质保留特性， 在一项随机、盲法、安慰剂对照的临床试验中对老年患者进行研究，2）评价NBD®在 减少术后抑郁、焦虑和灾难化，以及3）确定NBD®对患者的影响。 术后心理评分与阿片类药物用量的关系。这项研究预计将 改善手术疼痛缓解、术后阿片类药物的安全性，同时最大限度地减少阿片类药物的使用、依赖性和风险 每年有数百万美国人接受痛苦的手术。

PROJECT SUMMARY: Perioperative prescription of opioids is an important contributor to the current opioid epidemic, affecting ~4% of >50 million Americans undergoing surgery each year. The dose and duration of treatment of opioid in surgical patients is an established risk factor of opioid use disorder and overdose deaths. Although legislation and guidelines have been developed to limit the quantity of opioids prescribed following surgery in the US, in 2020, the number of opioid overdose deaths increased by 39% with worsening mental health and opioid use disorder in the context of COVID-19. Developing alternative and effective surgical analgesia and techniques to avoid or minimize the perioperative opioid use and opioid use disorder are critical in the fight of the current opioid epidemic. Auriculotherapy, a form of acupuncture, is an effective opioid-sparing alternative to treat pain. Use of traditional auriculotherapy is limited because the long and specific training requirement. Recently, a novel battery-powered and disposable auriculo-nerve field stimulator, NSS-2 Bridge Device® (NBD®), has been developed to overcome the limitations of the traditional auriculotherapy. NBD® is a disposable device that stimulates the branches of cranial nerves and of the superficial cervical plexus innervating the ear. The device has been cleared by the FDA to treat opioid withdrawal symptoms which includes abdominal pain and anxiety. The NBD® requires minimal training and allow to stimulate the auricular nerves for 5 days making NBD® a potential groundbreaking non-pharmacological approach to limit opioid use and prescription. Rodent studies are supportive of the NBD modulating pain pathways and decreasing inflammatory abdominal pain. Our human surgical pain pilot data is supportive that NBD® was effective in reducing postoperative opioid requirement in adults undergoing open surgery, especially in vulnerable older patients (>65 years). Our central hypothesis is that compared to a placebo, the NBD® will be an effective opioid-sparing tool in patients undergoing open surgery, and that the effectiveness of the NBD would be greater in vulnerable geriatric patients (age >65 years). Since, anxiety, depression, and catastrophizing increase post-operative pain and opioid requirement by up to 50% and since auriculotherapy reduces psychological symptoms, we also hypothesized that using NBD® will also reduce anxiety, depression and catastrophizing and that represents a mechanism by which NBD® reduce perioperative opioid requirements. Our multidisciplinary team is well positioned to test the following specific aims: 1) Quantify the opioid sparing property of NBD® following open surgery in vulnerable geriatric patients in a randomized, blinded, placebo-controlled clinical trial, 2) Evaluate the efficacy of NBD® in reducing postoperative depression, anxiety and catastrophization, and 3) Determine the effects of NBD® on the relationship of the postoperative psychological scores and opioid consumption. This research is expected to improve surgical pain relief, safety of postoperative opioids while minimizing opioid use, dependence, and risk of OUD in millions of Americans who have painful surgeries each year.