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Local vs General Anesthesia for Inguinal Hernia Repair in Older Adults

N/A
Recruiting
Led By Courtney Balentine, MD, MPH
Research Sponsored by University of Wisconsin, Madison
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age >=65 years
Presenting to clinic with a unilateral inguinal hernia that is not incarcerated
Must not have
Evidence of hernia incarceration or strangulation
Need for concurrent surgical repair at the time of hernia repair
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, estimated 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to determine which type of anesthesia is best for hernia repair in older adults: general or local. It seeks to address unanswered questions about the effects of anesthetic technique on cognitive function and quality of life.

Who is the study for?
This trial is for people aged 65 or older with a unilateral inguinal hernia that hasn't been repaired before and isn't trapped. They must be fit for either general or local anesthesia, willing to follow the study plan for six months post-surgery, and speak English as their primary language.
What is being tested?
The study compares outcomes of inguinal hernia surgery using different types of anesthesia: open repair under local anesthesia versus open repair or laparoscopic/robotic repair under general anesthesia in older adults.
What are the potential side effects?
Local anesthesia may cause less cognitive and physical decline in older patients compared to general anesthesia, which carries risks like confusion, memory issues, longer recovery times, and potential complications from being unconscious.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 65 years old or older.
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I have a one-sided groin hernia that isn't trapped.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a trapped or pinched hernia.
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I need another surgery at the same time as my hernia repair.
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I cannot have general anesthesia due to health reasons.
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My hernia has been repaired before.
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I do not have an infection that would prevent mesh use in hernia surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, estimated 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, estimated 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Participant satisfaction
Proportion of missing data
Proportion of participants completing all study visits
+2 more
Secondary study objectives
Anesthesia time
Carolinas Comfort Scale
Delirium
+7 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Open Inguinal Repair- Local anesthesiaExperimental Treatment1 Intervention
This arm will receive local anesthesia for their open inguinal hernia repair.
Group II: Inguinal Hernia Repair- General AnesthesiaActive Control1 Intervention
This arm will receive general anesthesia for their open inguinal hernia repair.

Find a Location

Who is running the clinical trial?

American Federation for Aging ResearchOTHER
8 Previous Clinical Trials
1,958 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,785 Previous Clinical Trials
28,184,684 Total Patients Enrolled
The John A. Hartford FoundationOTHER
17 Previous Clinical Trials
7,374 Total Patients Enrolled

Media Library

General Anesthesia Clinical Trial Eligibility Overview. Trial Name: NCT04706026 — N/A
Local Anesthesia Research Study Groups: Open Inguinal Repair- Local anesthesia, Inguinal Hernia Repair- General Anesthesia
Local Anesthesia Clinical Trial 2023: General Anesthesia Highlights & Side Effects. Trial Name: NCT04706026 — N/A
General Anesthesia 2023 Treatment Timeline for Medical Study. Trial Name: NCT04706026 — N/A
~53 spots leftby Aug 2026
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