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Actively Recruiting

Phase Not Applicable
Age: 60Years +
All Genders
Healthy Volunteers
ID04706026

Pilot Study Comparing Local and General Anesthesia for Inguinal Hernia Surgery in Adults 60 and Older Including Open, Laparoscopic, and Robotic Repair Approaches

Led by University of Wisconsin, Madison · Updated on 2026-01-07

80

Participants Needed

3

Research Sites

26 weeks

Total Duration

On this page

Sponsors

U

University of Wisconsin, Madison

Lead Sponsor

N

National Institute on Aging (NIA)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the use of local versus general anesthesia for inguinal hernia repair in Veterans aged 60 years and older. This pilot study aims to gather data to plan a larger, multisite randomized clinical trial by testing study procedures, recruiting participants, and measuring relevant outcomes. The study also seeks to identify barriers to wider use of local anesthesia and to provide training in clinical trial design and conduct. Participants are randomly assigned to one of three groups open inguinal hernia repair with local anesthesia, open inguinal hernia repair with general anesthesia, or laparoscopicrobotic hernia repair with general anesthesia. Local anesthesia involves injecting a mix of lidocaine with epinephrine and Marcaine at the surgical site along with intravenous sedation and pain medication. General anesthesia uses inhaled and intravenous anesthesia. The laparoscopic or robotic approach is included as it cannot be performed using local anesthesia. During the 6-month study period, participants will undergo surgery and anesthesia as assigned, followed by evaluations at various time points including baseline, 48 hours, 2 weeks, and 6 months after surgery. Researchers will collect data on enrollment rates, participant retention, time to complete assessments, satisfaction, pain levels, cognitive function, delirium, postoperative complications, and recovery times. This information will help refine study instruments and inform the design of future larger trials.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 60Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 60 years or older
  • Having a unilateral inguinal hernia that is not incarcerated
  • Suitable for either general or local anesthesia
  • Willing to complete all study requirements including follow-up for six months after surgery
  • English speaking
Not Eligible

You will not qualify if you...

  • Previous repair of the hernia being evaluated
  • Contraindications to general anesthesia
  • Allergies to local anesthesia
  • Evidence of hernia incarceration or strangulation
  • Active local or systemic infection preventing mesh use
  • Need for concurrent surgical repair during hernia surgery
  • Primary language is not English
  • Enrollment in other research studies
  • Clinical judgment excludes participation
  • Current pregnancy
  • Unwilling to provide consent
  • Active illegal drug use
  • Current alcoholism
  • Claustrophobia
  • Unable to lie on back for more than 30 minutes

Research Team

A

Anusha Talwalkar, MPH

B

Benjamin Cher, MD, MS

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