A Pilot Study of Local Anesthesia for Inguinal Hernia Surgery in Older Adults

University of Wisconsin (UW)

Status: Enrolling

Conditions: Anesthesia, Local; Inguinal Hernia

Treatments: Other: Inguinal Hernia Repair - General Anesthesia; Other: Open Inguinal Hernia Repair - Local Anesthesia

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04706026

2025-1446 (Other Identifier)

2023-0980

K76AG068515 (U.S. NIH Grant/Contract)

Protocol Version 6/26/25 (Other Identifier)

SMPH/SURGERY/ENDOCRINE (Other Identifier)

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 3 patient groups

Open Inguinal Repair- Local anesthesia

Experimental group

Description:

This arm will receive local anesthesia for their open inguinal hernia repair.

Treatment:

Other: Open Inguinal Hernia Repair - Local Anesthesia

Inguinal Hernia Repair- General Anesthesia

Active Comparator group

Description:

This arm will receive general anesthesia for their open inguinal hernia repair or laparoscopic / robotic repair.

Treatment:

Other: Inguinal Hernia Repair - General Anesthesia

Observational: Standard of Care

No Intervention group

Description:

Participants will receive anesthesia and surgery as decided by their care team.