Using local anesthesia for inguinal hernia surgery in older adults
A Pilot Study of Local Anesthesia for Inguinal Hernia Surgery in Older Adults
This study is testing whether using local anesthesia instead of general anesthesia for inguinal hernia surgery helps older adults recover better and avoid problems related to general anesthesia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | University of Wisconsin, Madison Academic / other |
| Locations | 3 sites (Dallas, Texas and 2 other locations) |
| Trial ID | NCT04706026 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to evaluate the outcomes of inguinal hernia repair in older adults using local anesthesia compared to general anesthesia. The research will identify relevant outcomes, understand barriers to the use of local anesthesia, and test study procedures to ensure effective recruitment and random assignment of participants. By focusing on older patients, the study addresses a critical need for improved surgical practices that minimize cognitive and physical decline associated with general anesthesia. The findings will help inform future multisite randomized trials and enhance surgical care for this population.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 65 and older with a unilateral inguinal hernia who are suitable for either anesthesia type.
Not a fit: Patients with prior hernia repairs, contraindications to general anesthesia, or those with allergies to local anesthesia may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to safer surgical options for older adults, reducing the risks associated with general anesthesia.
How similar studies have performed: Previous studies have shown promising results for local anesthesia in inguinal hernia repair, indicating potential benefits for older patients, although this specific focus on older adults is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Dallas, Texas and 2 other locations
- University of Texas Southwestern Medical Center — Dallas, Texas, United States (Recruiting)
- Baylor College of Medicine — Houston, Texas, United States (Recruiting)
- University of Wisconsin — Madison, Wisconsin, United States (Recruiting)
Study contacts
- Principal investigator: Courtney Balentine, MD, MPH — University of Wisconsin, Madison
- Study coordinator: Anusha Talwalkar, MPH
- Email: talwalkar@wisc.edu
- Phone: 608-265-9144
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.