A Pilot Study of Local Anesthesia for Inguinal Hernia Surgery in Older Adults
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorUniversity of Wisconsin, Madison
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Open Inguinal Hernia Repair - Local Anesthesia
Other interventionPatients 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 Anesthesia
Other interventionGeneral anesthesia will be administered at the discretion of the anesthesiologist and will involve a combination of inhaled and intravenous anesthesia.
Treatment groups
80 Participants
are divided into 3 treatment groupsGroup A: Open Inguinal Repair- Local anesthesiaExperimental treatment 1 intervention
Group B: Inguinal Hernia Repair- General AnesthesiaActive comparator 1 intervention
Group C: Observational: Standard of CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Rates of enrollment and percentage of eligible patients enrolled
Each week, research assistants will compile running counts of patients screened, found eligible, and enrolled.
Time frame
Through study completion, estimated 2 years2
Proportion of participants completing all study visits
Assistants will maintain counts of participants who complete each study visit.
Time frame
Through study completion, estimated 2 years3
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.
Time frame
Through study completion, estimated 2 years4
Time to complete study evaluations and instruments
Assistants will time participants while completing each study research form and will time the entire encounter.
Time frame
Time from beginning to end of completing study instrument, up to 2 hoursSecondary outcomes
1
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.
Time frame
Measured at baseline, 48 hours after surgery, 2 weeks after surgery, 6 months after surgery2
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.
Time frame
Measured at baseline, 48 hours after surgery, 2 weeks after surgery, 6 months after surgery3
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.
Time frame
Measured at baseline, prior to discharge, 48 hours after discharge, 2 weeks after surgery, 6 months after surgery4
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.
Time frame
Measured at baseline, prior to discharge, 48 hours after discharge, 2 weeks after surgery, 6 months after surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Wisconsin, Madison
Lead sponsor
National Institute on Aging (NIA)
Collaborator
American Federation for Aging Research
Collaborator
The John A. Hartford Foundation
Collaborator
Source ClinicalTrials.gov