A Pilot Study of Local Anesthesia for Inguinal Hernia Surgery in Older Adults
University of Wisconsin, Madison
80 participants
Oct 23, 2024
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
Inclusion Criteria5
- 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 Criteria15
- 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
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Interventions
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.
General anesthesia will be administered at the discretion of the anesthesiologist and will involve a combination of inhaled and intravenous anesthesia.
Locations(3)
View Full Details on ClinicalTrials.gov
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NCT04706026