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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Inguinal hernia repair-the most common general surgery operation in the U.S.-provides a unique opportunity to improve outcomes for older patients by changing surgical practice. Nearly 80% of inguinal hernia operations are performed under general anesthesia versus 15-20% using local anesthesia, despite the absence of evidence for superiority. The choice of anesthesia has particular implications for older adults because they face substantial short- and long-term risk of cognitive and physical decline after exposure to general anesthesia. Consequently, the American College of Surgeons and the American Geriatrics Society have identified a critical need in surgery: determining which operations have better outcomes when performed under local rather than general anesthesia. Currently, the evidence for choosing an anesthesia technique for inguinal hernia repair in older adults is inconclusive. Several small randomized trials and cohort studies have suggested that using local anesthesia for hernia repair reduces morbidity by one-third, unplanned readmissions by 20%, and operative time and costs by 15% while other studies showed no significant differences. However, there are significant flaws in these studies that severely limit their applicability to older adults: (1) They mainly focused on younger patients with limited comorbidity burden, largely ignoring individuals aged 65 years and older, (2) They did not adequately examine the effects of general anesthesia on cognitive function and quality of life for older adults and their caregivers, (3) They did not consult with stakeholders to identify outcomes relevant to those groups. The current study aims to address these limitations to determine the ideal anesthesia modality for inguinal hernia repair.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: t
View:

• Age \>=65 years

• Presenting to clinic with a unilateral inguinal hernia that is not incarcerated

• Considered suitable for either general or local anesthesia

• Willing to complete all study requirements, including follow-up continuing until six months after surgery

Locations
United States
Texas
University of Texas Southwestern Medical Center
RECRUITING
Dallas
Baylor College of Medicine
RECRUITING
Houston
Wisconsin
University of Wisconsin
RECRUITING
Madison
Contact Information
Primary
Elisa Marten, BA
martenl@surgery.wisc.edu
608-347-1609
Backup
Benjamin Cher
bcher@wisc.edu
608-263-7502
Time Frame
Start Date: 2024-10-23
Estimated Completion Date: 2027-03-01
Participants
Target number of participants: 80
Treatments
Experimental: Open Inguinal Repair- Local anesthesia
This arm will receive local anesthesia for their open inguinal hernia repair.
Active_comparator: Inguinal Hernia Repair- General Anesthesia
This arm will receive general anesthesia for their open inguinal hernia repair.
Related Therapeutic Areas
Sponsors
Collaborators: The John A. Hartford Foundation, National Institute on Aging (NIA), American Federation for Aging Research
Leads: University of Wisconsin, Madison

This content was sourced from clinicaltrials.gov