Status:

RECRUITING

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

Lead Sponsor:

University of Wisconsin, Madison

Collaborating Sponsors:

National Institute on Aging (NIA)

American Federation for Aging Research

Conditions:

Inguinal Hernia

Anesthesia, Local

Eligibility:

All Genders

60+ years

Phase:

NA

Brief Summary

The purpose of this study is to collect data about local versus general anesthesia for inguinal hernia repair in Veterans aged 60 years for planning a larger, multisite randomized clinical trial. Appr...

Detailed Description

The study rationale is that prior to conducting a multisite randomized trial, it is necessary to identify relevant outcomes, understand barriers to greater use of local anesthesia, test study procedur...

Eligibility Criteria

Inclusion

  • Age greater than or equal to 60 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
  • English speaking

Exclusion

  • The hernia that the patient is being evaluated for has undergone prior repair
  • Any contraindications to general anesthesia
  • Allergies to local anesthesia
  • Evidence of hernia incarceration or strangulation
  • Active local or systemic infection that would preclude the use of mesh for hernia repair
  • Need for concurrent surgical repair at the time of hernia repair
  • English is not the patient's primary language
  • Enrollment in other research studies
  • Clinical judgement of surgeon or anesthesiology
  • Current pregnancy
  • Unwilling to provide consent
  • Current active illegal drug use
  • Current alcoholism
  • Claustrophobia
  • Unable to tolerate lying in supine position for greater than 30 minutes

Key Trial Info

Start Date :

October 23 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

March 1 2027

Estimated Enrollment :

80 Patients enrolled

Trial Details

Trial ID

NCT04706026

Start Date

October 23 2024

End Date

March 1 2027

Last Update

January 7 2026

Active Locations (3)

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Page 1 of 1 (3 locations)

1

University of Texas Southwestern Medical Center

Dallas, Texas, United States, 75390

2

Baylor College of Medicine

Houston, Texas, United States, 77030

3

University of Wisconsin

Madison, Wisconsin, United States, 53705