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

Part of paid clinical trials in Dallas, Texas.

Sponsor
University of Wisconsin, Madison
Study ID
NCT04706026
Status
Recruiting
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Conditions

  • Anesthesia, Local
  • Inguinal Hernia

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Open Inguinal Hernia Repair - Local Anesthesia — OTHER
    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.
  • Inguinal Hernia Repair - General Anesthesia — OTHER
    General anesthesia will be administered at the discretion of the anesthesiologist and will involve a combination of inhaled and intravenous anesthesia.

Study Details

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.

Key Dates

Start date
Oct 23, 2024
Status verified
Jan 2026
Primary completion
Aug 31, 2026
Completion
Mar 1, 2027

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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 or laparoscopic / robotic repair.
  • No Intervention: Observational: Standard of Care
    Participants will receive anesthesia and surgery as decided by their care team.

Primary Outcome Measure

Rates of enrollment and percentage of eligible patients enrolled [ Time Frame: Through study completion, estimated 2 years ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
University of Texas Southwestern Medical CenterDallasTexas75390-
Baylor College of MedicineHoustonTexas77030
Robert Coffee
[email protected]
713-798-6970
University of WisconsinMadisonWisconsin53705
Elisa Marten
Courtney Balentine, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Texas Southwestern Medical Center· Dallas, TXBaylor College of Medicine· Houston, TXUniversity of Wisconsin· Madison, WI

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