Pilot Study of Anesthesia for Inguinal Hernia Surgery in Older Adults
This study is looking at different types of anesthesia for inguinal hernia (a bulge in the groin area) surgery in adults aged 60 and older. It compares open hernia repair using local anesthesia (lidocaine with epinephrine and Marcaine injected at the surgical site) with general anesthesia (inhaled and intravenous medicine to make you unconscious). A third group will have laparoscopic or robotic hernia repair with general anesthesia. The main goal is to gather information to help plan a larger study in the future. Researchers want to see how many eligible patients join, how many complete all study visits, and how much data is missing. About 80 participants will be enrolled, and the study status is currently unclear.
- Study design
- This is an interventional study planning to enroll about 80 participants. It will compare three different approaches for inguinal hernia repair.
- What's involved
- You would need to complete all study requirements, including follow-up visits for six months after surgery.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for six months after surgery.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Pilot Study of Local Anesthesia for Inguinal Hernia Surgery in Older Adults
At a glance
Conditions
Where it's being run
3 sites across 2 statesStudy leadership
- Courtney Balentine, MD, MPH · PRINCIPAL_INVESTIGATOR · University of Wisconsin, Madison
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Inclusion
Exclusion
What this trial measures
- Rates of enrollment and percentage of eligible patients enrolledThrough 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 visitsThrough study completion, estimated 2 years
Assistants will maintain counts of participants who complete each study visit.
- Proportion of missing dataThrough 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 instrumentsTime 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 satisfactionAt 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%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 trialFinal 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.