A Pilot Study of Local Anesthesia for Inguinal Hernia Surgery in Older Adults
University of Wisconsin, Madison
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.
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 procedures, and confirm our ability to adequately recruit and randomly assign participants. Additionally, the proposed study will provide the applicant with critical training in the design, conduct, and analysis of clinical trials. This will uniquely position the applicant to change surgical care for older adults. More specifically, the investigators plan to demonstrate the ability to successfully random…
Eligibility
- Age range
- 60+ years
- Sex
- All
- Healthy volunteers
- Yes
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…
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 CenterDallas, Texas
- Baylor College of MedicineHouston, Texas
- University of WisconsinMadison, Wisconsin