A Pilot Study of Local Anesthesia for Inguinal Hernia Surgery in Older Adults
5 other identifiers
interventional
80
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2024
Typical duration for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 10, 2020
CompletedFirst Posted
Study publicly available on registry
January 12, 2021
CompletedStudy Start
First participant enrolled
October 23, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2027
January 7, 2026
January 1, 2026
1.9 years
December 10, 2020
January 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
Rates of enrollment and percentage of eligible patients enrolled
Each week, research assistants will compile running counts of patients screened, found eligible, and enrolled.
Through study completion, estimated 2 years
Proportion of participants completing all study visits
Assistants will maintain counts of participants who complete each study visit.
Through study completion, estimated 2 years
Proportion of missing data
At each visit, every study visit will be entered into our electronic database and missing items will have a separate code number.
Through study completion, estimated 2 years
Time to complete study evaluations and instruments
Assistants will time participants while completing each study research form and will time the entire encounter.
Time from beginning to end of completing study instrument, up to 2 hours
Participant satisfaction
A 10 point likert scale will measure participant satisfaction. Scores range from 1-10 with higher scores indicating higher satisfaction.
At 6 month follow up
Whether Survey Instruments Can Be Eliminated due to Redundancy measured by R2 greater than 40%
Each survey instrument will be evaluated as the dependent variable in a separate linear regression with the scores of all other instruments used as predictors, along with demographic information. The adjusted R2 (explained variance) for each regression will be estimated. Any instrument where the R2 exceeds 40% will be eliminated based on the idea that little additional information is provided by including that instrument (i.e., the other surveys explain a substantial portion of the information contained within that instrument).
measured at 25 percent of planned enrollment and 75 percent of planned enrollment, estimated to be up to 1.5 years
Estimate sample size for fully powered randomized trial
For continuous variables, means and standard deviations will be estimated. For categorical variables, estimated proportions and 95% confidence intervals.
Final sample size estimate will be performed after data collection for the last patient is complete, estimated up to 2 years
Secondary Outcomes (10)
Carolinas Comfort Scale Score
Measured at baseline, 48 hours after surgery, 2 weeks after surgery, 6 months after surgery
Physical Function Score
Measured at baseline, 48 hours after surgery, 2 weeks after surgery, 6 months after surgery
Trail Making Test
Measured at baseline, prior to discharge, 48 hours after discharge, 2 weeks after surgery, 6 months after surgery
Montreal Cognitive Assessment
Measured at baseline, prior to discharge, 48 hours after discharge, 2 weeks after surgery, 6 months after surgery
Participants with Delirium
Measured at baseline, prior to discharge, 48 hours after discharge, 2 weeks after surgery, 6 months after surgery
- +5 more secondary outcomes
Study Arms (3)
Open Inguinal Repair- Local anesthesia
EXPERIMENTALThis arm will receive local anesthesia for their open inguinal hernia repair.
Inguinal Hernia Repair- General Anesthesia
ACTIVE COMPARATORThis arm will receive general anesthesia for their open inguinal hernia repair or laparoscopic / robotic repair.
Observational: Standard of Care
NO INTERVENTIONParticipants will receive anesthesia and surgery as decided by their care team.
Interventions
General anesthesia will be administered at the discretion of the anesthesiologist and will involve a combination of inhaled and intravenous 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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Wisconsin, Madisonlead
- National Institute on Aging (NIA)collaborator
- American Federation for Aging Researchcollaborator
- The John A. Hartford Foundationcollaborator
Study Sites (3)
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
University of Wisconsin
Madison, Wisconsin, 53705, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Courtney Balentine, MD, MPH
University of Wisconsin, Madison
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Masking Details
- The investigative team (except for the statistician and the surgeon) will be blinded to the treatment assignment until the final analysis is complete. The study team will not be blinded to the treatment assignments for participants in the observational arm.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 10, 2020
First Posted
January 12, 2021
Study Start
October 23, 2024
Primary Completion (Estimated)
August 31, 2026
Study Completion (Estimated)
March 1, 2027
Last Updated
January 7, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share