Пилотное исследование местной анестезии при хирургии паховой грыжи у пожилых людей
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.
Обзор исследования
Статус
Условия
Подробное описание
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.
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
-
-
Texas
-
Dallas, Texas, Соединенные Штаты, 75390
- University of Texas Southwestern Medical Center
-
Houston, Texas, Соединенные Штаты, 77030
- Baylor College of Medicine
-
-
Wisconsin
-
Madison, Wisconsin, Соединенные Штаты, 53705
- University of Wisconsin
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- 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
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
- 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
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Open Inguinal Repair- Local anesthesia
This arm will receive local anesthesia for their open inguinal hernia repair. |
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. |
|
Активный компаратор: Inguinal Hernia Repair- General Anesthesia
This arm will receive general anesthesia for their open inguinal hernia repair or laparoscopic / robotic repair. |
General anesthesia will be administered at the discretion of the anesthesiologist and will involve a combination of inhaled and intravenous anesthesia. |
|
Без вмешательства: Observational: Standard of Care
Participants will receive anesthesia and surgery as decided by their care team. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Rates of enrollment and percentage of eligible patients enrolled
Временное ограничение: Through study completion, estimated 2 years
|
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
Временное ограничение: Through study completion, estimated 2 years
|
Assistants will maintain counts of participants who complete each study visit. |
Through study completion, estimated 2 years
|
|
Proportion of missing data
Временное ограничение: 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. |
Through study completion, estimated 2 years
|
|
Time to complete study evaluations and instruments
Временное ограничение: 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. |
Time from beginning to end of completing study instrument, up to 2 hours
|
|
Participant satisfaction
Временное ограничение: 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. |
At 6 month follow up
|
|
Whether Survey Instruments Can Be Eliminated due to Redundancy measured by R2 greater than 40%
Временное ограничение: 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). |
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
Временное ограничение: 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. |
Final sample size estimate will be performed after data collection for the last patient is complete, estimated up to 2 years
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Carolinas Comfort Scale Score
Временное ограничение: Measured at baseline, 48 hours after surgery, 2 weeks after surgery, 6 months after surgery
|
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 at baseline, 48 hours after surgery, 2 weeks after surgery, 6 months after surgery
|
|
Physical Function Score
Временное ограничение: Measured at baseline, 48 hours after surgery, 2 weeks after surgery, 6 months after surgery
|
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 at baseline, 48 hours after surgery, 2 weeks after surgery, 6 months after surgery
|
|
Trail Making Test
Временное ограничение: Measured at baseline, prior to discharge, 48 hours after discharge, 2 weeks after surgery, 6 months after surgery
|
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 at baseline, prior to discharge, 48 hours after discharge, 2 weeks after surgery, 6 months after surgery
|
|
Montreal Cognitive Assessment
Временное ограничение: Measured at baseline, prior to discharge, 48 hours after discharge, 2 weeks after surgery, 6 months after surgery
|
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 at baseline, prior to discharge, 48 hours after discharge, 2 weeks after surgery, 6 months after surgery
|
|
Participants with Delirium
Временное ограничение: Measured at baseline, prior to discharge, 48 hours after discharge, 2 weeks after surgery, 6 months after surgery
|
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 at baseline, prior to discharge, 48 hours after discharge, 2 weeks after surgery, 6 months after surgery
|
|
Pain Level
Временное ограничение: Measured at baseline, prior to discharge, 48 hours after discharge, 2 weeks after surgery, 6 months after surgery
|
10 point visual analog scale. Patients indicate on a scale of 0-10 their current level of pain. Higher numbers indicate higher pain. |
Measured at baseline, prior to discharge, 48 hours after discharge, 2 weeks after surgery, 6 months after surgery
|
|
Postoperative complications
Временное ограничение: Up to 2 weeks
|
All complications will be recorded based on VA Surgical Quality Improvement Program definitions. |
Up to 2 weeks
|
|
Operative time
Временное ограничение: Time between surgery start and surgery end measured. 1 day of surgery
|
The amount of time the surgery takes (minutes) |
Time between surgery start and surgery end measured. 1 day of surgery
|
|
Anesthesia time
Временное ограничение: Time spent in operating room. 1 day of surgery
|
The amount of time in the operating room (minutes) |
Time spent in operating room. 1 day of surgery
|
|
Recovery time
Временное ограничение: Time spent in post anesthesia care unit. 1 day of surgery
|
Time spent in the post anesthesia care unit and stepdown units. |
Time spent in post anesthesia care unit. 1 day of surgery
|
Соавторы и исследователи
Спонсор
Соавторы
Следователи
- Главный следователь: Courtney Balentine, MD, MPH, University of Wisconsin, Madison
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 2023-0980
- SMPH/SURGERY/ENDOCRINE (Другой идентификатор: UW Madison)
- K76AG068515 (Грант/контракт NIH США)
- Protocol Version 6/26/25 (Другой идентификатор: UW Madison)
- 2025-1446 (Другой идентификатор: UW Madison - UW Health site)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .