Inguinal HerniaNCT04706026
A Pilot Study of Local Anesthesia for Inguinal Hernia Surgery in Older Adults
A study testing Open Inguinal Hernia Repair - Local Anesthesia and Inguinal Hernia Repair - General Anesthesia in people with Inguinal Hernia and Anesthesia, Local, run by University of Wisconsin, Madison at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Inguinal Hernia, Anesthesia, Local
- What is being tested?
- Open Inguinal Hernia Repair - Local Anesthesia and Inguinal Hernia Repair - General Anesthesia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 3 sitesUnited States
- Study dates
- 23 Oct 2024to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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 locations and contacts
3 sites in 1 country.
United States3 sites
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Baylor College of Medicine
Houston, Texas, 77030
University of Wisconsin
Madison, Wisconsin, 53705
About this study
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.
Read the detailed 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:
- 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
- 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
- Inguinal Hernia, Anesthesia, Local
- Being tested
- Open Inguinal Hernia Repair - Local Anesthesia, Inguinal Hernia Repair - General Anesthesia
- Keywords
- Elderly, Outcome, Inguinal hernia, Local anesthesia
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open Inguinal Hernia Repair - Local AnesthesiaOther
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 AnesthesiaOther
General anesthesia will be administered at the discretion of the anesthesiologist and will involve a combination of inhaled and intravenous anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Open Inguinal Repair- Local anesthesia | Experimental | This arm will receive local anesthesia for their open inguinal hernia repair. Receives: Other: Open Inguinal Hernia Repair - Local Anesthesia |
| Inguinal Hernia Repair- General Anesthesia | Active comparator | This arm will receive general anesthesia for their open inguinal hernia repair or laparoscopic / robotic repair. Receives: Other: Inguinal Hernia Repair - General Anesthesia |
| Observational: Standard of Care | No intervention | Participants will receive anesthesia and surgery as decided by their care team. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of enrollment and percentage of eligible patients enrolled
Each week, research assistants will compile running counts of patients screened, found eligible, and enrolled.
Measured: Through study completion, estimated 2 years
Proportion of participants completing all study visits
Assistants will maintain counts of participants who complete each study visit.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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: 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.
Measured: 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
The Carolinas Comfort Scale measures quality of life. Possible scores range from 1-6 for each item, with higher scores indicating increased quality of life.
Measured: Measured at baseline, 48 hours after surgery, 2 weeks after surgery, 6 months after surgery
Physical Function Score
The patients' ability to perform their activities of daily living will be measured with the 6 item Katz index. This scale is from 0-6, with higher scores indicating more functional independence.
Measured: Measured at baseline, 48 hours after surgery, 2 weeks after surgery, 6 months after surgery
Trail Making Test
Trail Making Test will be used to measure cognitive function. The time to complete the trail making test is measured, with those taking greater than expected time being considered deficient.
Measured: Measured at baseline, prior to discharge, 48 hours after discharge, 2 weeks after surgery, 6 months after surgery
Montreal Cognitive Assessment
Montreal Cognitive Assessment 5 minute form to measure cognitive function. For the Montreal Cognitive Assessment, the successfully completed skills are added to achieve a final score from 0-30, with higher numbers indicating closer to normal cognitive function.
Measured: Measured at baseline, prior to discharge, 48 hours after discharge, 2 weeks after surgery, 6 months after surgery
Participants with Delirium
The Confusion Assessment Method short form consists of 5 questions, if inattention + acute onset and/or fluctuating course + Disorganized thinking and/or Altered level of consciousness are present this test is considered positive for delirium.
Measured: Measured at baseline, prior to discharge, 48 hours after discharge, 2 weeks after surgery, 6 months after surgery
Pain Level
10 point visual analog scale. Patients indicate on a scale of 0-10 their current level of pain. Higher numbers indicate higher pain.
Measured: Measured at baseline, prior to discharge, 48 hours after discharge, 2 weeks after surgery, 6 months after surgery
Postoperative complications
All complications will be recorded based on VA Surgical Quality Improvement Program definitions.
Measured: Up to 2 weeks
Operative time
The amount of time the surgery takes (minutes)
Measured: Time between surgery start and surgery end measured. 1 day of surgery
Anesthesia time
The amount of time in the operating room (minutes)
Measured: Time spent in operating room. 1 day of surgery
Recovery time
Time spent in the post anesthesia care unit and stepdown units.
Measured: Time spent in post anesthesia care unit. 1 day of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2021
- Study start23 Oct 2024
- Primary completion31 Aug 2026
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inguinal HerniaStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There will be three study arms, participants will be randomized to 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.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), American Federation for Aging Research, The John A. Hartford Foundation
- Responsible party
- Sponsor
- Investigators
- Courtney Balentine, MD, MPH, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04706026
- Sponsor's protocol ID
- 2023-0980
- Other IDs
- Protocol Version 6/26/25, SMPH/SURGERY/ENDOCRINE, K76AG068515, 2025-1446
- Status last verified
- Oct 2026
- First submitted
- 10 Dec 2020
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Local Anesthesia for Inguinal Hernia Surgery in Older Adults
- ClinicalTrials.gov ID
- NCT04706026
- Acronym / sponsor ID
- 2023-0980
- Conditions
- Inguinal Hernia, Anesthesia, Local
- Keywords
- Elderly, Outcome, Inguinal hernia, Local anesthesia
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), American Federation for Aging Research, The John A. Hartford Foundation
- Study start
- 23 Oct 2024 (actual)
- Primary completion
- 31 Aug 2026 (actual)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 12 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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:
- 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
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- There will be three study arms, participants will be randomized to 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.
| Arm | Type | Receives |
|---|---|---|
| Open Inguinal Repair- Local anesthesia | Experimental | Other: Open Inguinal Hernia Repair - Local AnesthesiaThis arm will receive local anesthesia for their open inguinal hernia repair. |
| Inguinal Hernia Repair- General Anesthesia | Active comparator | Other: Inguinal Hernia Repair - General AnesthesiaThis arm will receive general anesthesia for their open inguinal hernia repair or laparoscopic / robotic repair. |
| Observational: Standard of Care | No intervention | –Participants will receive anesthesia and surgery as decided by their care team. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Open Inguinal Hernia Repair - Local AnesthesiaPatients 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. | Other | Open Inguinal Repair- Local anesthesia |
| Inguinal Hernia Repair - General AnesthesiaGeneral anesthesia will be administered at the discretion of the anesthesiologist and will involve a combination of inhaled and intravenous anesthesia. | Other | Inguinal Hernia Repair- General Anesthesia |
Primary outcome
Rates of enrollment and percentage of eligible patients enrolled
Time frame: Through study completion, estimated 2 years
Each week, research assistants will compile running counts of patients screened, found eligible, and enrolled.
Proportion of participants completing all study visits
Time frame: Through study completion, estimated 2 years
Assistants will maintain counts of participants who complete each study visit.
Proportion of missing data
Time frame: Through study completion, estimated 2 years
At each visit, every study visit will be entered into our electronic database and missing items will have a separate code number.
Time to complete study evaluations and instruments
Time frame: Time from beginning to end of completing study instrument, up to 2 hours
Assistants will time participants while completing each study research form and will time the entire encounter.
Participant satisfaction
Time frame: At 6 month follow up
A 10 point likert scale will measure participant satisfaction. Scores range from 1-10 with higher scores indicating higher satisfaction.
Whether Survey Instruments Can Be Eliminated due to Redundancy measured by R2 greater than 40%
Time frame: measured at 25 percent of planned enrollment and 75 percent of planned enrollment, estimated to be up to 1.5 years
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).
Estimate sample size for fully powered randomized trial
Time frame: Final sample size estimate will be performed after data collection for the last patient is complete, estimated up to 2 years
For continuous variables, means and standard deviations will be estimated. For categorical variables, estimated proportions and 95% confidence intervals.
10 secondary outcomes
Carolinas Comfort Scale Score
Time frame: Measured at baseline, 48 hours after surgery, 2 weeks after surgery, 6 months after surgery
Physical Function Score
Time frame: Measured at baseline, 48 hours after surgery, 2 weeks after surgery, 6 months after surgery
Trail Making Test
Time frame: Measured at baseline, prior to discharge, 48 hours after discharge, 2 weeks after surgery, 6 months after surgery
Montreal Cognitive Assessment
Time frame: Measured at baseline, prior to discharge, 48 hours after discharge, 2 weeks after surgery, 6 months after surgery
Participants with Delirium
Time frame: Measured at baseline, prior to discharge, 48 hours after discharge, 2 weeks after surgery, 6 months after surgery
Pain Level
Time frame: Measured at baseline, prior to discharge, 48 hours after discharge, 2 weeks after surgery, 6 months after surgery
Postoperative complications
Time frame: Up to 2 weeks
Operative time
Time frame: Time between surgery start and surgery end measured. 1 day of surgery
Anesthesia time
Time frame: Time spent in operating room. 1 day of surgery
Recovery time
Time frame: Time spent in post anesthesia care unit. 1 day of surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Courtney Balentine, MD, MPH principal investigator
University of Wisconsin, Madison
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Open Inguinal Hernia Repair - Local Anesthesia and Inguinal Hernia Repair - General Anesthesia in people with Inguinal Hernia and Anesthesia, Local, run by University of Wisconsin, Madison at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rates of enrollment and percentage of eligible patients enrolled (time frame: Through study completion, estimated 2 years). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.