A Pilot Study of Local Anesthesia for Inguinal Hernia Surgery in Older Adults
A Pilot Study of Local Anesthesia for Inguinal Hernia Surgery in Older Adults
批准号:
10327256
负责人:
Courtney J Balentine
金额:
$24.62万
依托单位国家:
美国
项目类别:
财政年份:
2021
资助国家:
美国
项目状态:
已结题
起止时间:
2021-09-30 至 2022-03-31
关键词:
Admission activityAdultAffectAgingAmericanAmerican College of SurgeonsAnesthesia proceduresAnestheticsCaregiversClinical TrialsCognitiveCohort StudiesCountryDataElderlyEnrollmentEvidence based interventionExposure toFocus GroupsFundingGeneral AnesthesiaGeriatricsGoalsHealth systemHerniaHospitalsImpaired cognitionIndividualInguinal HerniaInterviewKnowledgeLeadLeadershipLocal anesthesiaMeasurementMeasuresModalityModelingMorbidity - disease rateOperative Surgical ProceduresOutcomeOutcome MeasureOutcome StudyPainParticipantPatient-Focused OutcomesPatientsPerceptionPhysical FunctionPhysiciansPilot ProjectsPopulationPopulation StudyPositioning AttributePostoperative ComplicationsPostoperative PeriodProceduresQuality of lifeRandomizedRandomized Clinical TrialsRecoveryResearchResearch PersonnelRetrospective cohortRoleSocietiesStructureSurgeonTechniquesTestingTimeTrainingagedarmcareerclinical trial analysiscognitive functioncomorbiditycostdesignhuman old age (65+)implementation scienceimprovedimproved outcomeinstrumentmulti-site trialolder patientoperationpostoperative recoveryprofessorprogramsrandomized trialrecruitrepairedskillssurgery outcometrial comparingvirtual
中文摘要
腹股沟疝修补术--美国最常见的普通外科手术--提供了一种独特的
有机会通过改变手术实践来改善老年人的预后。近80%的腹股沟疝气
手术是在全身麻醉下进行的,而使用局部麻醉的比例为15%-20%。尽管有些人
研究表明,全身麻醉会导致老年人的认知和身体衰退,
选择麻醉技术用于老年人腹股沟疝修补术的证据尚不确定。
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%,而其他研究表明没有
有显著差异。不幸的是,这些研究存在重大缺陷,限制了它们在
上了年纪的人。特别是,以前的研究大多涉及更年轻和更健康的患者,没有分析
局部麻醉在老年人中是否有更大的潜在好处。我们进行了第一次大规模的,
一项基于人群的研究,评估了局部麻醉和全身麻醉对老年人预后的影响。vbl.使用
一种工具变量方法来分析大量老年人的回溯队列,我们发现了一个强大的
局部麻醉与改善术中、围手术期和术后结果之间的关系。这项建议是
在多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。
应聘者是一名外科助理教授,其长期职业目标是将专业知识与
实施科学和临床试验,以促进以患者为中心的老年人在之前、期间、
而且在手术后。该项目的目标是获得初步数据,为多点随机试验的设计提供依据
65岁及以上成人腹股沟疝修补术全身麻醉与局部麻醉的比较。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将
目标1:确定患者身份-
在局部麻醉与全身麻醉的随机临床试验中测量的中心结果,以及
评估患者对疝气手术的感知如何影响麻醉选择。目标2:确定
局部麻醉使用的潜在障碍和随机试验的潜在结果
外科医生、麻醉师和医院领导层的观点。
减少发病率,提高生活质量。我们提出了以下具体目标:
目标3:进行试点
评估和改进研究程序并确定招募可行性的随机研究,
老年人局部麻醉与全身麻醉的多部位随机试验的随机化和保留率
正在接受腹股沟疝气手术的成年人。研究的预期结果是(1)关键的初步数据
一项比较局部麻醉和全身麻醉用于老年人腹股沟疝修补术的多点试验的通知设计,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相结合
并让我在外科衰老研究中担任全国领导角色。
英文摘要
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.
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A Pilot Study of Local Anesthesia for Inguinal Hernia Surgery in Older Adults
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批准号:10697398
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项目类别:
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资助金额:$24.02万
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财政年份:2021
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负责人:Courtney J Balentine
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依托单位:
A Pilot Study of Local Anesthesia for Inguinal Hernia Surgery in Older Adults
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批准号:10666243
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项目类别:
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资助金额:$24.3万
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财政年份:2021
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负责人:Courtney J Balentine
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依托单位:
海外基金