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.

项目摘要/摘要乳腺癌占女性的四分之一癌症的诊断，影响了多达八分之一的女性美国。所有乳腺癌患者都接受手术，但手术并非没有风险，并且是相关的具有多种副作用。手术中的许多并发症来自使用全身麻醉以及术中和术后阿片类药物。全身麻醉的副作用包括血液动力学不稳定性，术后恶心和呕吐，抑制细胞介导的免疫抑制，认知障碍和延迟恢复。阿片类药物的使用也与术后恶心和呕吐，肠道，尿位retention留有关，瘙痒和免疫抑制。通常，术中和术后阿片类药物的使用通常会导致增加需要使用非医学阿片类药物使用和阿片类药物的技术风险。大量数据支持使用非药理学干预措施，包括接受侵入性医学的患者的催眠（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明显减少，表现出有益的生理反应，要求较少的镇痛药，并花费更少的时间程序室多于控件。在许多研究中，改善了患者报告的结果和整体高级医疗费用也与满意度平行。所有这些先前的研究都提供了 HS在简单的医疗程序（例如乳房活检）或更多侵入性手术（例如乳房）之前手术和一名外科团队成员进行的手术期间，手术和RCT没有提供催眠。拟议的试验将对乳腺癌的男性和男性随机进行肿瘤切除术±前哨对三组之一的节点活检：1）手术前后的局部麻醉，芬太尼和HS的手术（HS）; 2）HS在接受通常护理的全身麻醉前（HS-GA；提案输注，芬太尼和局部）麻药）;或3）通常的护理全身麻醉（GA）。该研究将检查阿片类药物使用，疼痛，手术前后，焦虑，恶心，疲劳和认知功能障碍。还将追踪恢复14 手术后90天。该研究还将检查与相关的医疗费用的群体差异程序时间，恢复室时间和药物使用。该项目将允许进一步探索HS 在临床团队成员提供的手术期间，并探索相关的生物心理社会过程使用镇痛和使用阿片类药物，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。我们专门提议检验HS的假设在乳腺癌手术期间，将导致更好的镇痛控制以及较低的阿片类药物使用，减少疼痛和心理压力和比GA更快的恢复速度。拟议研究的数据将有助于移动干预护理标准，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。