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A Pilot Study of Local Anesthesia for Inguinal Hernia Surgery in Older Adults

Studies

Study First Submitted Date 2020-12-10
Study First Posted Date 2021-01-12
Last Update Posted Date 2023-08-03
Start Month Year February 1, 2024
Primary Completion Month Year June 30, 2026
Verification Month Year July 2023
Verification Date 2023-07-31
Last Update Posted Date 2023-08-03

Detailed Descriptions

Sequence: 20724124
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. There have been two prior randomized clinical trials that compared local versus general anesthesia for inguinal hernia repair. One study randomized 616 patients in Sweden to local, regional, or general anesthesia. They did not specifically look at older patients but the mean age in each group was 56 years old. They found that the total operative time was five minutes faster for the local anesthesia group (90 versus 95 minutes) the incidence of postoperative pain requiring opioids and catheterization for urinary retention was decreased by 29% for the local compared to general anesthesia group and the rate of unplanned admission was decreased by 19%. A cost-effectiveness analysis conducted by the same group indicated that hospital costs were lower in the local anesthesia group (a difference of €311/$378) and total healthcare costs were also lower (€316/$384). A second trial from Scotland randomized 279 patients to local or general anesthesia, with a mean age of 55 years for both groups. This study did not find a significant difference in operative time, complications, length of stay, pain, or neurocognitive recovery as measured by a battery of tests. However, they did not specifically analyze outcomes in older patients which would tend to dilute the potential benefits of local anesthesia. Equally important, this study focused almost exclusively on healthy patients with smaller hernias, as evidenced by >90% of patients having an American Society of Anesthesiology score of 1 or 2 and a mean total surgical time of 48 minutes for each group. There are several observational studies that compare outcomes from hernia repair under local or general anesthesia, and these mostly suggest that local anesthesia is associated with shorter operative time (5-10 minutes), fewer complications (1-3% reduction), and enhanced quality of life. However, only two of these studies look specifically at outcomes for older adults and both suffer from a poor approach to risk adjustment. Additionally, all the observational studies have a limited assessment of complications and failed to effectively evaluate rates of urinary retention and catheterization after surgery. Urinary retention is the most common complication of general anesthesia after hernia repair and results in considerable discomfort for patients who are catheterized to relieve it. Additionally, when patients do not resolve retention in a timely fashion, it results in the need for unplanned admission which increases hospital costs. The intervention chosen for testing in this study is the choice of anesthesia (local or general) for unilateral inguinal hernia repair. These are the primary methods of anesthesia for inguinal hernia surgery by 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, and malignant hyperthermia. The main risks of local anesthesia include allergic reaction and hypotension (when the anesthetic is improperly injected into a blood vessel).

Browse Interventions

Sequence: 96060897 Sequence: 96060898 Sequence: 96060899
Mesh Term Anesthetics Mesh Term Central Nervous System Depressants Mesh Term Physiological Effects of Drugs
Downcase Mesh Term anesthetics Downcase Mesh Term central nervous system depressants Downcase Mesh Term physiological effects of drugs
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Conditions

Sequence: 52177786 Sequence: 52177787
Name Inguinal Hernia Name Anesthesia, Local
Downcase Name inguinal hernia Downcase Name anesthesia, local

Id Information

Sequence: 40163279
Id Source org_study_id
Id Value STU-2020-0558

Design Groups

Sequence: 55600492 Sequence: 55600493 Sequence: 55600494
Group Type Experimental Group Type Active Comparator Group Type Active Comparator
Title Open repair- Local anesthesia Title Open repair- General anesthesia Title Laparoscopic or robotic repair- general anesthesia
Description This arm will receive local anesthesia for their open inguinal hernia repair. Description This arm will receive general anesthesia for their open inguinal hernia repair. Description This arm will receive general anesthesia for their laparoscopic or robotic hernia repair

Interventions

Sequence: 52491876 Sequence: 52491877 Sequence: 52491878
Intervention Type Other Intervention Type Other Intervention Type Other
Name Open repair- Local anesthesia Name Open repair- General anesthesia Name Laparoscopic or robotic repair- general anesthesia
Description This is the treatment group. Patients 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. Description This group is the active comparator. General anesthesia will be administered at the discretion of the anesthesiologist and will involve a combination of inhaled and intravenous anesthesia. The hernia will be repaired using an open technique. Description This group is a second active comparator. General anesthesia will be administered at the discretion of the anesthesiologist and will involve a combination of inhaled and intravenous anesthesia. The hernia will be repaired using a robotic or laparoscopic technique.

Keywords

Sequence: 79877046 Sequence: 79877047 Sequence: 79877048 Sequence: 79877049
Name Elderly Name Outcome Name Inguinal hernia Name Local anesthesia
Downcase Name elderly Downcase Name outcome Downcase Name inguinal hernia Downcase Name local anesthesia

Design Outcomes

Sequence: 177405382 Sequence: 177405383 Sequence: 177405384 Sequence: 177405385 Sequence: 177405386 Sequence: 177405387 Sequence: 177405388 Sequence: 177405389 Sequence: 177405390 Sequence: 177405391 Sequence: 177405392 Sequence: 177405393 Sequence: 177405394 Sequence: 177405395 Sequence: 177405396 Sequence: 177405397 Sequence: 177405398 Sequence: 177405399 Sequence: 177405400 Sequence: 177405401 Sequence: 177405402 Sequence: 177405403 Sequence: 177405404 Sequence: 177405405 Sequence: 177405406 Sequence: 177405407 Sequence: 177405408 Sequence: 177405409 Sequence: 177405410 Sequence: 177405411 Sequence: 177405412 Sequence: 177405413 Sequence: 177405414
Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure Rates of enrollment and percentage of eligible patients enrolled Measure Proportion of participants completing all study visits Measure Proportion of missing data Measure Time to complete study evaluations and instruments Measure Partipant satisfaction Measure Carolinas Comfort Scale Measure Carolinas Comfort Scale Measure Carolinas Comfort Scale Measure Carolinas Comfort Scale Measure Physical function Measure Physical function Measure Physical function Measure Physical function Measure Trail Making Test Measure Montreal Cognitive Assessment Measure Trail Making Test Measure Montreal Cognitive Assessment Measure Trail Making Test Measure Montreal Cognitive Assessment Measure Trail Making Test Measure Montreal Cognitive Assessment Measure Delirium Measure Delirium Measure Delirium Measure Delirium Measure Pain level Measure Pain level Measure Pain level Measure Pain level Measure Postoperative complications Measure Operative time Measure Anesthesia time Measure Recovery time
Time Frame Through study completion, estimated 2 years Time Frame Through study completion, estimated 2 years Time Frame Through study completion, estimated 2 years Time Frame Time from beginning to end of completing study instrument, up to 2 hours Time Frame At 6 month follow up Time Frame Measured at baseline Time Frame Measured at 48 hours after surgery Time Frame Measured at 2 weeks after surgery Time Frame Measured at 6 months after surgery Time Frame Measured at baseline Time Frame Measured at 48 hours after surgery Time Frame Measured at 2 weeks after surgery Time Frame Measured at 6 months after surgery Time Frame Measured at baseline Time Frame Measured at baseline Time Frame Measured at 48 hours after surgery Time Frame Measured at 48 hours after surgery Time Frame Measured at 2 weeks after surgery Time Frame Measured at 2 weeks after surgery Time Frame Measured at 6 months after surgery Time Frame Measured at 6 months after surgery Time Frame Measured at baseline Time Frame Measured at 48 hours after surgery Time Frame Measured at 2 weeks after surgery Time Frame Measured at 6 months after surgery Time Frame Measured at baseline Time Frame Measured at 48 hours after surgery Time Frame Measured at 2 weeks after surgery Time Frame Measured at 6 months after surgery Time Frame Up to 2 weeks Time Frame Time between surgery start and surgery end measured. 1 day of surgery Time Frame Time spent in operating room. 1 day of surgery Time Frame Time spent in post anesthesia care unit. 1 day of surgery
Description Each week, research assistants will compile running counts of patients screened, found eligible, and enrolled. Description Assistants will maintain counts of participants who complete each study visit. Description At each visit, every study visit will be entered into our electronic database and missing items will have a separate code number. Description Assistants will time participants while completing each study research form and will time the entire encounter. Description A 10 point likert scale will measure participant satisfaction. Scores range from 1-10 with higher scores indicating higher satisfaction. Description 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. Description 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. Description 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. Description 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. Description We will measure the patients' ability to perform their activities of daily living with the 6 item katz index. This scale is from 0-6, with higher scores indicating more functional independnce. Description We will measure the patients' ability to perform their activities of daily living with the 6 item katz index. This scale is from 0-6, with higher scores indicating more functional independnce. Description We will measure the patients' ability to perform their activities of daily living with the 6 item katz index. This scale is from 0-6, with higher scores indicating more functional independnce. Description We will measure the patients' ability to perform their activities of daily living with the 6 item katz index. This scale is from 0-6, with higher scores indicating more functional independnce. Description Trail Making Test will be used to measure cognitive function. The time to complete the trailmaking test is measured, with those taking greater than expected time being considered deficient. Description 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. Description The Trail Making Test will be used to measure cognitive function. The time to complete the trailmaking test is measured, with those taking greater than expected time being considered deficient. Description 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. Description The Trail Making Test will be used to measure cognitive function. The time to complete the trailmaking test is measured, with those taking greater than expected time being considered deficient. Description Montreal Cognitive Assessment 5 minute form used 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. Description Trail Making Test used to measure cognitive function. The time to complete the trailmaking test is measured, with those taking greater than expected time being considered deficient. Description 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. Description 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. Description 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. Description 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. Description 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. Description 10 point visual analog scale. Patients indicate on a scale of 0-10 their current level of pain. Higher numbers indicate higher pain. Description 10 point visual analog scale. Patients indicate on a scale of 0-10 their current level of pain. Higher numbers indicate higher pain. Description 10 point visual analog scale. Patients indicate on a scale of 0-10 their current level of pain. Higher numbers indicate higher pain. Description 10 point visual analog scale. Patients indicate on a scale of 0-10 their current level of pain. Higher numbers indicate higher pain. Description All complications will be recorded based on VA Surgical Quality Improvement Program definitions. Description The amount of time the surgery takes (minutes) Description The amount of time in the operating room (minutes) Description Time spent in the post anesthesia care unit and stepdown units.

Browse Conditions

Sequence: 193511446 Sequence: 193511447 Sequence: 193511448 Sequence: 193511449
Mesh Term Hernia Mesh Term Hernia, Inguinal Mesh Term Pathological Conditions, Anatomical Mesh Term Hernia, Abdominal
Downcase Mesh Term hernia Downcase Mesh Term hernia, inguinal Downcase Mesh Term pathological conditions, anatomical Downcase Mesh Term hernia, abdominal
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48325045 Sequence: 48325046 Sequence: 48325047
Agency Class OTHER Agency Class OTHER Agency Class OTHER
Lead Or Collaborator lead Lead Or Collaborator collaborator Lead Or Collaborator collaborator
Name University of Texas Southwestern Medical Center Name University of Wisconsin, Madison Name Baylor College of Medicine

Overall Officials

Sequence: 29288540
Role Principal Investigator
Name Courtney Balentine, MD, MPH
Affiliation University of Texas

Central Contacts

Sequence: 12010758 Sequence: 12010759
Contact Type primary Contact Type backup
Name Elisa Martin, BS Name Courtney Balentine, MD, MPH
Phone 608-347-1609
Email martenl@surgery.wisc.edu
Role Contact Role Contact

Design Group Interventions

Sequence: 68158145 Sequence: 68158146 Sequence: 68158147
Design Group Id 55600492 Design Group Id 55600493 Design Group Id 55600494
Intervention Id 52491876 Intervention Id 52491877 Intervention Id 52491878

Eligibilities

Sequence: 30769037
Gender All
Minimum Age 65 Years
Maximum Age N/A
Healthy Volunteers Accepts Healthy Volunteers
Criteria Inclusion Criteria: Age >=65 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 Exclusion Criteria: 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
Adult False
Child False
Older Adult True

Calculated Values

Sequence: 253933130
Registered In Calendar Year 2020
Were Results Reported False
Has Single Facility False
Minimum Age Num 65
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 5
Number Of Secondary Outcomes To Measure 28

Designs

Sequence: 30515196
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking Single
Intervention Model Description There will be three groups: (1) Open inguinal hernia repair with general anesthesia, (2) Open repair with local anesthesia, (3) Laparoscopic or robotic repair with general anesthesia
Subject Masked True

Provided Documents

Sequence: 2580187
Document Type Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Has Protocol True
Has Icf True
Has Sap True
Document Date 2020-12-18
Url https://ClinicalTrials.gov/ProvidedDocs/26/NCT04706026/Prot_SAP_ICF_000.pdf

Responsible Parties

Sequence: 28881500
Responsible Party Type Principal Investigator
Name Courtney Balentine
Title Associate Professor
Affiliation University of Wisconsin, Madison