Actively Recruiting
A Pilot Study of Local Anesthesia for Inguinal Hernia Surgery in Older Adults
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 laparoscopic/robotic 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
Eligibility Criteria
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
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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo inguinal hernia surgery using local anesthesia, general anesthesia, or laparoscopic/robotic repair as assigned.
1 day of surgery
Duration - Up to 6 months
Participants are monitored for recovery and postoperative complications, and complete assessments of physical function, cognitive function, pain, and satisfaction.
Visits at 48 hours, 2 weeks, and 6 months after surgery
Trial Site Locations
Total: 3 locations
1
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
2
Baylor College of Medicine
Houston, Texas, United States, 77030
Actively Recruiting
3
University of Wisconsin
Madison, Wisconsin, United States, 53705
Actively Recruiting
Research Team
A
Anusha Talwalkar, MPH
B
Benjamin Cher, MD, MS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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