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OPTIMIZING OUTPATIENT ANESTHESIA: IMPROVING ANALGESIA AND REDUCING OPIOID MISADVENTURE

优化门诊麻醉：改善镇痛并减少阿片类药物事故

基本信息

批准号：
10087912
负责人：
Evan D. Kharasch
金额：
$ 50.52万
依托单位：
DUKE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2018
资助国家：
美国
起止时间：
2018-07-01 至 2023-12-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10087912
关键词：
Absence of pain sensation Acute Address Adverse effects Ambulatory Surgical Procedures American Americas Anesthesia procedures Caring Cellular Phone Cessation of life Chronic Clinical Research Clinical Trials Country Data Day Surgery Development Dose Double-Blind Method Effectiveness Epidemic Face General Anesthesia Goals Healthcare Heroin Home Hospitals Hour Human Incidence Inpatients Medical Methadone Neurofibrillary Tangles Operative Surgical Procedures Opiate Addiction Opioid Outcome Outpatients Overdose Pain Pain intensity Pain management Patients Perioperative Pharmaceutical Preparations Pharmacotherapy Policies Population Postoperative Pain Postoperative Period Public Health Randomized Recovery Reporting Research Risk Factors Safety Surgeon System Tablets Telephone Testing Therapeutic Time Work addiction chronic pain cohort compare effectiveness experience functional independence fundamental research health related quality of life improved innovation inpatient surgery multimodality novel opioid epidemic opioid misuse opioid mortality opioid overdose opioid use overdose death pain reduction pain relief patient safety pill postoperative recovery prescription opioid prescription opioid abuse prescription opioid misuse prospective side effect surgical pain trend

项目摘要

PROJECT SUMMARY/ABSTRACT The overall long-term objectives of this research are to: (1) reduce the over-prescribing of postoperative discharge opioids which contribute to the population reservoir of unused pills available for patient misuse, and for the diversion and misadventure which are contributing to the devastating public health problem of opioid addiction, overdose, and death; and (2) improve pain treatment, decrease postoperative opioid requirements, increase patient safety, and diminish opioid-related adverse and side effects after outpatient surgery. Our research fundamentally challenges long-practiced yet untested notions that opioids of short duration are the best way to treat surgical pain and to help patients. Anesthesiologists and surgeons face the challenge that surgical pain is inadequately treated in >80% of patients, 10-50% of whom develop chronic postsurgical pain, for which acute postoperative pain is the single greatest risk factor. Opioids are the primary pharmacotherapy for surgical pain, yet with increased use of short-duration opioids, surgical pain treatment has not improved over the past two decades. In contrast, three decades of clinical research and experience shows that a single intraoperative dose of a long-duration opioid (i.e. methadone), which sustains therapeutic drug concentrations, produces better analgesia than repeated doses of short-duration opioids and reduces further opioid requirements, in inpatient surgery. Nevertheless, in outpatient surgery, methadone has never been evaluated, and the potential benefits of methadone in outpatient surgery regarding better postoperative pain, side effects, safety, and reduced opioid consumption remain unrealized. This is a missed opportunity. We will test the innovative, paradigm-shifting hypothesis that in outpatient surgery, intraoperative anesthesia with methadone, compared with conventional short-duration opioids, achieves better analgesia, with similar or diminished side effects, reduces development of chronic postsurgical pain, improves postoperative recovery, and most importantly, decreases postoperative opioid consumption. Demonstrating reduced opioid consumption and hence diminishing prescribing of take-home opioids could shrink the population reservoir of unused opioids available for diversion and misuse, and reduce addiction, overdose, and death. This hypothesis will be tested in two prospective, randomized, double-blind clinical trials, with separate outpatient cohorts of short-stay (overnight <24 hours) and same-day surgery. We will compare general anesthesia with single-dose methadone vs as needed short-duration opioids, evaluate intraoperative and postoperative opioid use, opioid side effects, short-term and long-term postoperative pain, and overall quality of recovery for up to 1 year. Successful completion of the aims portends improved outpatient surgical care, enhanced patient recovery, and reduced postoperative opioid use. An ensuing revolutionary redesign of anesthesia care, and transformational approach to and reduction of postoperative opioid prescribing, would shrink the pool of prescription opioids in America, and help address one of the primary contributory factors to the opioid epidemic.

项目总结/摘要本研究的总体长期目标是：（1）减少术后过度处方释放阿片类药物，这有助于患者误用未使用的药丸的人群储存，以及因为转移和意外事故导致阿片类药物的毁灭性公共卫生问题，成瘾、过量和死亡;和（2）改善疼痛治疗，减少术后阿片类药物需求，增加患者安全性，并减少门诊手术后阿片类药物相关的不良反应和副作用。我们研究从根本上挑战了长期实践但未经检验的观念，即短期阿片类药物是治疗手术疼痛和帮助病人的最佳方法。麻醉师和外科医生面临的挑战是，手术疼痛在>80%的患者中治疗不充分，其中10-50%的患者发展为慢性术后疼痛，术后急性疼痛是最大的风险因素。阿片类药物是主要的药物疗法对于手术疼痛，但随着短期阿片类药物使用的增加，手术疼痛的治疗并没有得到改善在过去的二十年里。相反，三十年的临床研究和经验表明，术中给予维持治疗药物浓度的长期阿片类药物（即美沙酮），产生比短时间阿片类药物重复剂量更好的镇痛作用，要求，在住院手术。然而，在门诊手术中，美沙酮从未被评估过，以及美沙酮在门诊手术中关于更好的术后疼痛，副作用，安全性和减少阿片类药物消费仍然没有实现。这是一个错失的机会。我们将测试创新的，范式转变的假设，在门诊手术，术中麻醉与美沙酮，与传统的短持续时间阿片类药物相比，效果，减少慢性术后疼痛的发展，改善术后恢复，最重要的是，减少术后阿片类药物消耗。证明阿片类药物消费减少，因此，减少处方的带回家阿片类药物可以减少未使用阿片类药物的人口储备可用于转移和滥用，并减少成瘾，过量和死亡。这一假设将得到检验在两项前瞻性、随机、双盲临床试验中，（过夜<24小时）和当天手术。我们将比较全身麻醉和单次给药美沙酮与按需短期阿片类药物，评价术中和术后阿片类药物的使用，阿片类药物副作用、短期和长期术后疼痛以及长达1年的总体恢复质量。目标的成功完成预示着门诊手术护理的改善，患者康复的提高，减少术后阿片类药物的使用。随之而来的是麻醉护理的革命性重新设计，减少术后阿片类药物处方的方法，将缩小处方阿片类药物的库，美国，并帮助解决阿片类药物流行的主要促成因素之一。