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Recruiting NCT04706026

NCT04706026 A Pilot Study of Local Anesthesia for Inguinal Hernia Surgery in Older Adults

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Clinical Trial Summary
NCT ID NCT04706026
Status Recruiting
Phase
Sponsor University of Wisconsin, Madison
Condition Inguinal Hernia
Study Type INTERVENTIONAL
Enrollment 80 participants
Start Date 2024-10-23
Primary Completion 2026-08-31

Eligibility & Interventions

Sex All sexes
Min Age 60 Years
Max Age N/A
Study Type INTERVENTIONAL
Interventions
Open Inguinal Hernia Repair - Local AnesthesiaInguinal Hernia Repair - General Anesthesia

Eligibility Fast-Check

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 80 participants in total. It began in 2024-10-23 with a primary completion date of 2026-08-31.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

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. Approximately 80 participants will be enrolled and can expect to be on study for 6 months.

Eligibility Criteria

Inclusion Criteria: * 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 Criteria: * 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

Contact & Investigator

Central Contact

Anusha Talwalkar, MPH

✉ talwalkar@wisc.edu

📞 608-265-9144

Principal Investigator

Courtney Balentine, MD, MPH

PRINCIPAL INVESTIGATOR

University of Wisconsin, Madison

Frequently Asked Questions

Who can join the NCT04706026 clinical trial?

This trial is open to participants of all sexes, aged 60 Years or older, studying Inguinal Hernia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT04706026 currently recruiting?

Yes, NCT04706026 is actively recruiting participants. Contact the research team at talwalkar@wisc.edu for enrollment information.

Where is the NCT04706026 trial being conducted?

This trial is being conducted at Dallas, United States, Houston, United States, Madison, United States.

Who is sponsoring the NCT04706026 clinical trial?

NCT04706026 is sponsored by University of Wisconsin, Madison. The principal investigator is Courtney Balentine, MD, MPH at University of Wisconsin, Madison. The trial plans to enroll 80 participants.

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