权益分类	功能权益	普通用户	{{item.name}}会员
{{category.name}}	{{benefitItem.name}}

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

乳腺癌手术期间护士催眠的阿片类药物节省效果

基本信息

批准号：
10668632
负责人：
Lorenzo Cohen
金额：
$ 66.95万
依托单位：
UNIVERSITY OF TX MD ANDERSON CAN CTR
依托单位国家：
美国
项目类别：
财政年份：
2023
资助国家：
美国
起止时间：
2023-05-01 至 2028-04-30
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10668632
关键词：
Absence of pain sensation Address Affect Analgesics Anesthesia procedures Anxiety Breast Cancer Treatment Breast biopsy Cellular Immunity Certified registered nurse anesthetist Clinical Data Day Surgery Dose Europe Fatigue Fentanyl General Anesthesia Hypnosis Ileus Immunosuppression Impaired cognition Individual Differences Infusion procedures Intervention Intravenous Anesthesia Laryngeal Masks Light Local Anesthetics Local anesthesia Medical Medical Care Costs Methods Mission Nausea Neurologic Nurses Operative Surgical Procedures Opioid Pain Patient Outcomes Assessments Patient Self-Report Patients Pharmaceutical Preparations Physiological Population Postoperative Nausea and Vomiting Postoperative Period Procedures Process Propofol Pruritus Psychological Stress Psychosocial Factor Public Health Randomized Recovery Recovery Room Reporting Research Risk Schedule Sentinel Lymph Node Biopsy Serious Adverse Event Surgical complication Techniques Testing Thinking Time Time and Motion Studies Unconscious State United States United States National Institutes of Health Urinary Retention Vomiting Woman absorption biopsychosocial breast lumpectomy breast surgery cancer diagnosis cancer surgery cancer therapy clinical practice cost cost effective economic evaluation efficacy evaluation expectation hemodynamics improved improved outcome instrumentation intervention effect malignant breast neoplasm member men morphine equivalent opioid epidemic opioid misuse opioid sparing opioid use outcome prediction pain sensitivity postoperative recovery psychologic randomized trial response satisfaction side effect standard care standard of care time use trait treatment as usual tumor wound healing

项目摘要

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.

项目概要/摘要乳腺癌占女性癌症诊断的四分之一，影响了多达八分之一的女性美国。所有乳腺癌患者都会接受手术，但手术并非没有风险，并且与具有多种副作用。许多手术并发症都是由于使用全身麻醉造成的以及术中和术后阿片类药物。全身麻醉的副作用包括血流动力学不稳定，术后恶心呕吐、细胞免疫抑制、认知障碍和迟发恢复。阿片类药物的使用还与术后恶心和呕吐、肠梗阻、尿潴留、瘙痒症、免疫抑制等。通常，术中和术后阿片类药物的使用往往会导致阿片类药物的增加需要了解非医疗阿片类药物使用的风险和阿片类药物节约技术。大量数据支持使用对接受侵入性医疗的患者进行非药物干预，包括催眠（HS）程序。在各种医疗人群中，使用 HS 的患者报告焦虑和疼痛明显减轻，表现出有益的生理反应，需要更少的镇痛药物，并花更少的时间程序室比控制室。在许多研究中，患者报告的结果和总体效果得到改善满意度的提高还伴随着医疗费用的下降。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（例如乳房）之前发生 HS 手术期间，没有随机对照试验在其中一名手术团队成员进行的手术期间提供催眠。拟议的试验将随机分配患有乳腺癌并计划进行肿瘤切除术的女性和男性±哨兵对三组之一进行淋巴结活检：1) 手术前和手术期间使用局部麻醉剂、芬太尼和 HS （高中）； 2) 手术前常规全身麻醉（HS-GA；输注异丙酚、芬太尼和局部麻醉）麻药）;或 3) 常规护理全身麻醉 (GA)。该研究将探讨阿片类药物使用、疼痛、手术前后的焦虑、恶心、疲劳和认知功能障碍。恢复情况也将被追踪 14 以及手术后 90 天。该研究还将检查与以下疾病相关的医疗费用的群体差异：手术时间、恢复室时间和药物的使用。该项目将进一步探索 HS 在临床团队成员提供的手术期间，探索相关的生物心理社会过程镇痛和阿片类药物的使用、麻醉和疼痛，并检查基线个体差异因素与干预效果和恢复有关。我们特别建议检验 HS 的假设在乳腺癌手术期间，将带来更好的镇痛控制，同时减少阿片类药物的使用、减少疼痛和心理压力大，恢复比GA快。拟议研究的数据将有助于推动这一目标干预护理标准并将 HS 的使用扩展到其他侵入性医疗程序中可以避免全身麻醉。