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

• 批准号: 9719812
• 负责人: Evan D. Kharasch
• 金额: $ 55.99万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-07-01 至 2021-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9719812
• 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 environment; 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

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.

项目概要/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，这会导致大量未使用的药物可供患者滥用，以及 因阿片类药物的转移和不幸事件导致了毁灭性的公共健康问题 成瘾、服药过量和死亡； (2) 改善疼痛治疗，减少术后阿片类药物的需求， 提高患者安全性，并减少门诊手术后阿片类药物相关的不良反应和副作用。我们的 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有效的 治疗手术疼痛和帮助患者的最佳方法。麻醉科医生和外科医生面临的挑战是 >80% 的患者手术疼痛未得到充分治疗，其中 10-50% 出现慢性术后疼痛， 术后急性疼痛是最大的单一危险因素。阿片类药物是主要药物治疗 手术疼痛，但随着短期阿片类药物使用的增加，手术疼痛治疗并未得到改善 过去二十年。相比之下，三十年的临床研究和经验表明，单一 术中服用长效阿片类药物（即美沙酮），以维持治疗药物浓度， 比重复剂量的短期阿片类药物产生更好的镇痛效果，并进一步减少阿片类药物 住院手术中的要求。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的潜在益处，包括改善术后疼痛、副作用、 安全性和阿片类药物消费量的减少仍未实现。这是一个错失的机会。我们将测试 创新的、范式转变的假设，即在门诊手术中，使用美沙酮进行术中麻醉， 与传统的短持续时间阿片类药物相比，镇痛效果更好，副作用相似或减弱 效果，减少慢性术后疼痛的发展，改善术后恢复，并且大多数 重要的是，减少术后阿片类药物的消耗。证明阿片类药物消费量减少 因此，减少带回家的阿片类药物的处方可能会减少未使用的阿片类药物的人口储备 可用于转移和滥用，并减少成瘾、用药过量和死亡。这个假设将被检验 在两项前瞻性、随机、双盲临床试验中，分别对短期住院患者进行分组 （过夜<24 小时）和当天手术。我们将比较全身麻醉与单剂量麻醉 美沙酮与按需短期阿片类药物的比较，评估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、患者康复的加强以及 减少术后阿片类药物的使用。随后对麻醉护理进行革命性的重新设计和变革 方法和减少术后阿片类药物处方，将缩小术后阿片类药物处方池 美国，并帮助解决阿片类药物流行的主要促成因素之一。