A Pilot Study of Local Anesthesia for Inguinal Hernia Surgery in Older Adults

老年人腹股沟疝气手术局部麻醉的初步研究

• 批准号: 10327256
• 负责人: Courtney J Balentine
• 金额: $ 24.62万
• 依托单位: UT SOUTHWESTERN MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-30 至 2022-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10327256
• 关键词: Admission activity; Adult; Affect; Aging; American; American College of Surgeons; Anesthesia procedures; Anesthetics; Caregivers; Clinical Trials; Cognitive; Cohort Studies; Country; Data; Elderly; Enrollment; Evidence based intervention; Exposure to; Focus Groups; Funding; General Anesthesia; Geriatrics; Goals; Health system; Hernia; Hospitals; Impaired cognition; Individual; Inguinal Hernia; Interview; Knowledge; Lead; Leadership; Local anesthesia; Measurement; Measures; Modality; Modeling; Morbidity - disease rate; Operative Surgical Procedures; Outcome; Outcome Measure; Outcome Study; Pain; Participant; Patient-Focused Outcomes; Patients; Perception; Physical Function; Physicians; Pilot Projects; Population; Population Study; Positioning Attribute; Postoperative Complications; Postoperative Period; Procedures; Quality of life; Randomized; Randomized Clinical Trials; Recovery; Research; Research Personnel; Retrospective cohort; Role; Societies; Structure; Surgeon; Techniques; Testing; Time; Training; aged; arm; career; clinical trial analysis; cognitive function; comorbidity; cost; design; human old age (65+); implementation science; improved; improved outcome; instrument; multi-site trial; older patient; operation; postoperative recovery; professor; programs; randomized trial; recruit; repaired; skills; surgery outcome; trial comparing; virtual

Inguinal hernia repair – the most common general surgery operation in the U.S. – provides a unique opportunity to improve outcomes for older adults by changing surgical practice. Nearly 80% of inguinal hernia operations are performed under general anesthesia versus 15%-20% using local anesthesia. Although some studies suggest that exposure to general anesthesia can cause cognitive and physical decline in older adults, the evidence for choosing an anesthesia technique for inguinal hernia repair in older adults is inconclusive. Several studies demonstrated that using local anesthesia for hernia repair reduced morbidity by one-third, unplanned admissions by 20%, and operative time and costs by 15%, while other studies showed no significant differences. Unfortunately, these studies have significant shortcomings that limit their applicability for older adults. In particular, prior studies mostly involved younger and healthier patients, with no analysis of whether potential benefits of local anesthesia were greater in older adults. We conducted the first large, population-based study that evaluated how local and general anesthesia affect outcomes in older adults. Using an instrumental variable approach to analyze a large retrospective cohort of older adults, we identified a strong association between local anesthesia and improved intra-, peri-, and postoperative outcomes. This proposal is the next logical step toward verifying those findings in a multisite randomized clinical trial. The applicant is an assistant professor in surgery whose long-term career goal is to integrate expertise in implementation science and clinical trials to promote patient-centered outcomes for older adults before, during, and after surgery. The project goal is to obtain preliminary data to inform design of a multisite randomized trial comparing general versus local anesthesia for inguinal hernia repair in adults aged 65 years and older. We hypothesize that using local rather than general anesthesia for inguinal hernia repair in older adults will Aim 1: Identify patient- centered outcomes to measure in a randomized clinical trial of local versus general anesthesia, and evaluate how patient perceptions of hernia surgery affect anesthesia selection. Aim 2: Identify potential barriers to use of local anesthesia and potential outcomes for a randomized trial from the perspective of surgeons, anesthesiologists, and hospital leadership. reduce morbidity and enhance quality of life. We propose the following specific aims: Aim 3: Conduct a pilot randomized study to assess and refine study procedures and determine feasibility of recruitment, randomization, and retention for a multisite randomized trial of local versus general anesthesia in older adults having inguinal hernia surgery. Expected outcomes of the study are (1) crucial preliminary data to inform design of a multisite trial comparing local versus general anesthesia for hernia repair in older adults, and (2) training in and knowledge of clinical trials that will synergize with my background in implementation science and position me to take a national leadership role in surgical aging research.

腹股沟疝修补术-在美国最常见的普通外科手术-提供了一个独特的 通过改变手术实践来改善老年人的结果。近80%的腹股沟疝 手术在全身麻醉下进行，而15%-20%使用局部麻醉。尽管一些 研究表明暴露于全身麻醉可导致老年人的认知和身体衰退， 老年人腹股沟疝修补术麻醉技术的选择尚无定论。 几项研究表明，使用局部麻醉进行疝修补术可将发病率降低三分之一， 计划外入院减少20%，手术时间和费用减少15%，而其他研究表明， 显著差异。不幸的是，这些研究有明显的缺点，限制了它们的适用性， 老年人特别是，以前的研究大多涉及年轻和健康的患者，没有分析 局部麻醉的潜在益处是否在老年人中更大。我们进行了第一次大型的， 一项基于人群的研究，评估了局部麻醉和全身麻醉如何影响老年人的结局。使用 一个工具变量的方法来分析一个大型的回顾性队列的老年人，我们发现了一个强大的 局部麻醉与术中、术中和术后结局改善之间的相关性。这项建议是 这是在多地点随机临床试验中验证这些发现的下一个合乎逻辑的步骤。 申请人是外科助理教授，其长期职业目标是将专业知识整合到 实施科学和临床试验，以促进老年人以患者为中心的结果之前，期间， 手术后也是如此该项目的目标是获得初步数据，为多中心随机试验的设计提供信息 比较65岁及以上成人腹股沟疝修补术的全身麻醉与局部麻醉。我们 假设在老年人腹股沟疝修补术中使用局部麻醉而不是全身麻醉， 目标1：识别患者- 在局部麻醉与全身麻醉的随机临床试验中测量集中结局，以及 评估患者对疝手术的看法如何影响麻醉选择。目标2：确定 使用局部麻醉的潜在障碍和来自 外科医生、麻醉师和医院领导的观点。 降低发病率，提高生活质量。我们提出以下具体目标： 目标3：进行试点 随机研究，以评估和完善研究程序，并确定招募的可行性， 老年人局部麻醉与全身麻醉的多中心随机试验的随机化和保留 腹股沟疝的治疗方法研究的预期成果是：（1）关键的初步数据， 一项比较局部麻醉与全身麻醉用于老年人疝修补术的多中心试验的信息设计，以及 (2)临床试验方面的培训和知识，将与我在实施科学方面的背景协同作用 让我在外科衰老研究中担任国家领导角色