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: 10666243
• 负责人: Courtney J Balentine
• 金额: $ 24.3万
• 依托单位: UNIVERSITY OF WISCONSIN-MADISON
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-01 至 2025-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10666243
• 关键词: Admission activity; Adult; Age; Aging; American; American College of Surgeons; Anesthesia procedures; Anesthetics; Caregivers; Caring; Clinical Trials; Cognitive; Cohort Studies; Country; Data; Databases; Elderly; Enrollment; Exposure to; Funding; General Anesthesia; Geriatrics; Goals; Health system; Hernia; Hospital Administrators; Hospitals; Impaired cognition; Individual; Inguinal Hernia; Institution; Interview; Knowledge; Local anesthesia; Measures; Morbidity - disease rate; Nurses; Operative Surgical Procedures; Outcome; Outcome Measure; Outcome Study; Participant; Patient-Focused Outcomes; Patients; Physical Function; Physicians; Pilot Projects; Population; Positioning Attribute; Postoperative Complications; Procedures; Provider; Quality of life; Randomized; Recovery; Research Personnel; Resources; Societies; Structure; Surgeon; System; Target Populations; Techniques; Testing; Time; Training; United States Department of Veterans Affairs; aged; arm; career; clinical trial analysis; cognitive function; comorbidity; cost; design; functional status; human old age (65+); implementation science; improved; improved outcome; instrument; member; multi-site trial; older patient; operation; pilot trial; postoperative recovery; professor; prospective; randomized trial; recruit; repaired; surgery outcome; surgical research; trial comparing

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, and our preliminary data suggest that the benefits of local anesthesia increase with age. The applicant is an assistant professor in surgery whose long-term career goal is to use 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 support a multisite 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 reduce morbidity and enhance quality of life. We propose the following specific aims: (1) Identify the optimal target population for a pilot study of general versus local anesthesia among patients aged 65 and older who are undergoing inguinal hernia repair. We will use a national database of operations in the Veterans Affairs system to determine which subsets of older patients (age, comorbidity, and functional status) are most likely to have complications or prolonged operative and recovery time with general anesthesia. (2) Determine which outcomes of inguinal hernia repair are most relevant to patients, caregivers, providers, and hospital administrators for a pilot trial of local versus general anesthesia for hernia repair in older adults. We will interview stakeholders to identify outcomes valued by each group. (3) Conduct a pilot 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. We will conduct a pilot randomized trial of local versus general anesthesia (30 patients/arm) targeting the population identified in aim 1 and assessing outcomes from aim 2. We will measure rates of enrollment among eligible patients, assess acceptability of study instruments, and verify our ability to follow patients and measure outcomes at each time point. Expected outcomes of the study are (1) crucial preliminary data for planning and executing a multisite trial comparing general versus local anesthesia for hernia repair in older adults, and (2) training and knowledge necessary for the applicant to become a leader in surgical research.

腹股沟疝修补术是美国最常见的普通外科手术，提供了独特的治疗方法 通过改变手术实践来改善老年人预后的机会。近80%为腹股沟疝气 手术在全身麻醉下进行，而 15%-20% 使用局部麻醉。虽然有些 研究表明，全身麻醉会导致老年人认知能力和身体素质下降， 选择老年人腹股沟疝气修复麻醉技术的证据尚无定论。 多项研究表明，使用局部麻醉进行疝气修复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%，而其他研究表明没有 显着差异。不幸的是，这些研究存在重大缺陷，限制了它们的适用性 老年人，我们的初步数据表明局部麻醉的益处随着年龄的增长而增加。 申请人是一名外科助理教授，其长期职业目标是利用专业知识 实施科学和临床试验，以促进老年人在之前、期间、期间以患者为中心的结果 以及手术后。该项目的目标是获得初步数据以支持比较一般情况的多站点试验 与 65 岁及以上成人腹股沟疝修补术的局部麻醉相比。我们假设 使用局部麻醉而不是全身麻醉来修复老年人的腹股沟疝气将降低发病率和 提高生活质量。我们提出以下具体目标：（1）确定最佳目标人群 一项对 65 岁及以上接受手术的患者进行全身麻醉与局部麻醉的试点研究 腹股沟疝修补术。我们将使用退伍军人事务系统中的国家运营数据库来 确定老年患者的哪些子集（年龄、合并症和功能状态）最有可能患有 全身麻醉的并发症或手术和恢复时间延长。 (2) 确定哪一个 腹股沟疝修补术的结果与患者、护理人员、提供者和医院最相关 管理人员进行局部麻醉与全身麻醉用于老年人疝气修复的试点试验。我们 将采访利益相关者以确定每个群体所重视的结果。 （三）开展试点研究评估 完善研究程序并确定招募、随机化和保留的可行性 一项对患有腹股沟疝的老年人进行局部麻醉与全身麻醉的多中心随机试验 外科手术。我们将针对局部麻醉与全身麻醉（30 名患者/臂）进行一项试点随机试验 目标 1 中确定的人口并评估目标 2 的结果。我们将衡量入学率 在符合条件的患者中，评估研究仪器的可接受性，并验证我们跟踪患者和治疗的能力 测量每个时间点的结果。研究的预期结果是（1）关键的初步数据 计划和执行一项多站点试验，比较老年人疝气修复的全身麻醉与局部麻醉 成人，以及 (2) 申请人成为外科研究领导者所需的培训和知识。