RecruitingNot ApplicableNCT04706026

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


Sponsor

University of Wisconsin, Madison

Enrollment

80 participants

Start Date

Oct 23, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This pilot study is comparing two types of anesthesia for inguinal hernia surgery in older adults: general anesthesia (where you are fully unconscious) versus local anesthesia (where only the surgical area is numbed while you remain awake). Inguinal hernias happen when tissue pushes through a weak spot in the groin muscles, causing a bulge. Surgery is often the recommended treatment, and doctors are exploring whether local anesthesia might be safer or lead to better recovery for older patients. The study is specifically designed for patients aged 60 and above, as older adults can sometimes have more risks with general anesthesia. Researchers will follow participants for up to six months after surgery to compare how both groups recover and whether there are differences in complications or outcomes. You may be eligible if... - You are 60 years of age or older - You have a unilateral (one-sided) inguinal hernia that is not trapped (incarcerated) - Your doctor considers you suitable for either general or local anesthesia - You are willing to attend all follow-up visits for six months after surgery - You speak English You may NOT be eligible if... - Your hernia has already been repaired before - You have contraindications to general anesthesia or allergies to local anesthesia - Your hernia is incarcerated or strangulated (blood supply cut off) - You are currently pregnant - You have active drug or alcohol dependence, or claustrophobia - You are participating in another research study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHEROpen Inguinal Hernia Repair - Local Anesthesia

Patients in the local anesthesia arm will receive an injection of a 50:50 mix of 1% lidocaine with epinephrine and 0.25% Marcaine at the surgical site (in the skin and subcutaneous layers + beneath the external oblique aponeurosis). Patients in the local arm will also receive intravenous sedation (Propofol or Precedex) and pain medication (morphine or fentanyl) at the discretion of the attending anesthesiologist.

OTHERInguinal Hernia Repair - General Anesthesia

General anesthesia will be administered at the discretion of the anesthesiologist and will involve a combination of inhaled and intravenous anesthesia.


Locations(3)

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Baylor College of Medicine

Houston, Texas, United States

University of Wisconsin

Madison, Wisconsin, United States

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NCT04706026


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