Opioid-Sparing Effects of Nurse-Delivered Hypnosis During Breast Cancer Surgery

项目摘要/摘要 乳腺癌占女性癌症诊断的四分之一，影响到多达八分之一的女性 美国。所有的乳腺癌患者都会接受手术，然而手术并非没有风险，而且与 有很多副作用。手术的许多并发症都是由于使用全身麻醉造成的。 以及术中和术后的阿片类药物。全身麻醉的副作用包括血流动力学不稳定， 术后恶心和呕吐、细胞免疫抑制、认知障碍和延迟 恢复。阿片类药物的使用还与术后恶心呕吐、肠梗阻、尿潴留、 瘙痒和免疫抑制。通常情况下，术中和术后使用阿片类药物往往会导致 非医用阿片类药物使用的风险和保留阿片类药物的技术是必要的。大量的数据支持使用 侵入性医疗患者的非药物干预，包括催眠(HS) 程序。在各种医疗人群中，使用HS的患者报告的焦虑和疼痛显著减少， 表现出有益的生理反应，要求较少的止痛药，并在 程序室而不是控制室。在多项研究中，患者报告的结果和总体上的改善 满意度的同时，医疗成本也在下降。所有这些先前的研究要么提供了 在简单的医疗程序(例如，乳房活检)期间或在更具侵入性的程序(如乳房)之前进行HS 手术期间，没有RCT提供催眠，手术团队中的一名成员提供了催眠。 拟议的试验将随机选择乳腺癌患者和男性患者进行肿块切除术。 结节活检分为三组：1)手术前和手术中使用局麻药、芬太尼和HS。 (2)术前全身麻醉(HS-GA；异丙酚输注、芬太尼和局部麻醉) 麻醉)；或3)常规护理全身麻醉(GA)。这项研究将考察阿片类药物使用、疼痛、 手术前后的焦虑、恶心、疲劳和认知功能障碍。复苏也将被跟踪14 术后90天。这项研究还将检查与以下各项相关的医疗费用的群体差异 手术时间、恢复室时间和药物使用情况。该项目将允许进一步探索HS 在手术期间由临床团队成员提供，并探索相关的生物心理社会过程 与止痛和阿片类药物的使用、麻醉和疼痛有关，并检查基线个体差异因素 与干预效果和康复有关。我们特别建议检验以下假设：HS 在乳腺癌手术期间，将产生更好的止痛控制，同时减少阿片类药物的使用，减少疼痛和 心理压力大，恢复快于GA。拟议研究的数据将有助于推动这一进程 干预护理标准，并将HS的使用扩大到其他侵入性医疗程序，如 全身麻醉是可以避免的。

PROJECT SUMMARY/ABSTRACT Breast cancer accounts for one in four cancer diagnoses in women, affecting up to one in eight women in the United States. All patients with breast cancer undergo surgery, yet surgery is not without risks and is associated with a multitude of side effects. Many of the complications from surgery are from the use of general anesthesia and intra- and postoperative opioids. Side effects of general anesthesia include hemodynamic instability, postoperative nausea and vomiting, suppression of cell-mediated immunity, cognitive impairment, and delayed recovery. The use of opioids is also associated with postoperative nausea and vomiting, ileus, urinary retention, pruritus, and immunosuppression. Frequently, intra- and postoperative opioid use often leads to an increased risk for non-medical opioid use and opioid-sparing techniques are needed. Extensive data supports the use of non-pharmacological interventions including hypnosedation (HS) for patients undergoing invasive medical procedures. In a variety of medical populations, patients using HS report significantly less anxiety and pain, demonstrate beneficial physiological responses, request less analgesic medication, and spend less time in the procedure room than controls. In a number of studies, the improved patient-reported outcomes and overall satisfaction was also paralleled by decreased medical costs. All of these previous studies either delivered the HS during simple medical procedures (e.g., breast biopsy) or before more invasive procedures such as breast surgery and no RCTs have provided hypnosis during surgery delivered by one of the surgical team members. The proposed trial will randomize women and men with breast cancer scheduled for a lumpectomy ± sentinel node biopsy to one of three groups: 1) surgery with a local anesthetic, fentanyl, and HS before and during surgery (HS); 2) HS before surgery with usual care general anesthesia (HS-GA; propofol infusion, fentanyl, and local anesthetic); or 3) Usual care general anesthesia (GA). The study will examine differences in opioid use, pain, anxiety, nausea, fatigue, and cognitive dysfunction before and after surgery. Recovery will be also tracked 14 and 90 days after surgery. The study will also examine group differences in medical costs associated with procedure time, recovery room time, and use of medications. This project will allow further exploration of HS during surgery provided by a clinical team member and to explore the biopsychosocial processes associated with analgesia and opioid use, anesthesia, and pain and examine baseline individual difference factors associated with the intervention effects and recovery. We specifically propose to test the hypothesis that HS during breast cancer surgery will result in better analgesia control along with lower opioid use, less pain and psychological stress, and faster recovery than GA. Data from the proposed study will help to move this intervention into the standard of care and expand the use of HS into other invasive medical procedures where general anesthesia may be avoided.