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

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.

Grant Number: 5K76AG068515-04
NIH Institute/Center: NIH
Principal Investigator: Courtney Balentine