A Pilot Study of Local Anesthesia for Inguinal Hernia Surgery in Older Adults
NCT ID: NCT04706026
Last Updated: 2025-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
80 participants
INTERVENTIONAL
2024-10-23
2027-03-01
Brief Summary
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Detailed Description
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More specifically, the investigators plan to demonstrate the ability to successfully randomize Veterans aged 60 years and older to local versus general anesthesia for inguinal hernia surgery, and to validate processes and instruments to measure relevant outcomes.
Although the original NIA-approved proposal involved only two arms, open hernia repair using local anesthesia and open repair using local anesthesia, the study team subsequently published a paper that showed using local anesthesia for open hernia repair may also be superior to laparoscopic or robotic hernia repair. Consequently, a third arm is added to our pilot study: laparoscopic or robotic hernia repair with general anesthesia (these surgical approaches cannot be done using local anesthesia). The rationale is that use of laparoscopic or robotic inguinal hernia surgery, while still less common than open repair, is becoming more common and no prior randomized trials have compared laparoscopic/robotic surgery versus open repair using local anesthesia.
Local or general anesthesia are the primary methods of anesthesia for inguinal hernia surgery for most surgeons (though some perform the operation under spinal or regional anesthesia, this is rare). Both approaches are used in clinical practice with acceptable known risks and complications. General anesthesia is associated with risks of hypotension, venous thromboembolism, heart attack, stroke, pulmonary dysfunction, cognitive dysfunction, allergic reaction, urinary retention, and malignant hyperthermia. The main risks of local anesthesia include allergic reaction and hypotension (when the anesthetic is improperly injected into a blood vessel).
The primary objective is to:
1. demonstrate ability to successfully recruit, randomize, and retain patients aged 60 years and older for a randomized trial of local versus general anesthesia for inguinal hernia surgery, and
2. establish the ability to measure relevant outcomes and test protocols and study instruments for measuring key outcomes.
The secondary objective is to generate preliminary comparisons between the study arms, to inform effect size estimates for a larger multisite trial.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
1. Open and laparoscopic / robotic inguinal hernia repair under general anesthesia (Control Group)
2. Inguinal hernia repair with local anesthesia (Experimental Group)
An Observational standard of care arm will supplement accrual in each arm to help reach the goal of 80 participants.
TREATMENT
SINGLE
Study Groups
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Open Inguinal Repair- Local anesthesia
This arm will receive local anesthesia for their open inguinal hernia repair.
Open 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.
Inguinal Hernia Repair- General Anesthesia
This arm will receive general anesthesia for their open inguinal hernia repair or laparoscopic / robotic repair.
Inguinal 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.
Observational: Standard of Care
Participants will receive anesthesia and surgery as decided by their care team.
No interventions assigned to this group
Interventions
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Open 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.
Inguinal 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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
60 Years
ALL
Yes
Sponsors
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National Institute on Aging (NIA)
NIH
American Federation for Aging Research
OTHER
The John A. Hartford Foundation
OTHER
University of Wisconsin, Madison
OTHER
Responsible Party
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Principal Investigators
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Courtney Balentine, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of Wisconsin, Madison
Locations
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University of Texas Southwestern Medical Center
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
University of Wisconsin
Madison, Wisconsin, United States
Countries
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Central Contacts
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Facility Contacts
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Robert Coffee
Role: primary
Elisa Marten
Role: primary
Other Identifiers
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Protocol Version 6/26/25
Identifier Type: OTHER
Identifier Source: secondary_id
SMPH/SURGERY/ENDOCRINE
Identifier Type: OTHER
Identifier Source: secondary_id
2025-1146
Identifier Type: OTHER
Identifier Source: secondary_id
2023-0980
Identifier Type: -
Identifier Source: org_study_id