A Pilot Study of Local Anesthesia for Inguinal Hernia Surgery in Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 18
- 试验地点
- 3
- 主要终点
- Rates of enrollment and percentage of eligible patients enrolled
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
The investigative team (except for the statistician and the surgeon) will be blinded to the treatment assignment until the final analysis is complete. The study team will not be blinded to the treatment assignments for participants in the observational arm.
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Open Inguinal Repair- Local anesthesia
This arm will receive local anesthesia for their open inguinal hernia repair.
干预措施: Open Inguinal Hernia Repair - Local Anesthesia (Other)
Observational: Standard of Care
Participants will receive anesthesia and surgery as decided by their care team.
Inguinal Hernia Repair- General Anesthesia
This arm will receive general anesthesia for their open inguinal hernia repair or laparoscopic / robotic repair.
干预措施: Inguinal Hernia Repair - General Anesthesia (Other)
结局指标
主要结局
Rates of enrollment and percentage of eligible patients enrolled
时间窗: 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
时间窗: Through study completion, estimated 2 years
Assistants will maintain counts of participants who complete each study visit.
Proportion of missing data
时间窗: 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
时间窗: 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
时间窗: 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%
时间窗: 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
时间窗: 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.
Rates of enrollment and percentage of eligible patients enrolled
时间窗: 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
时间窗: Through study completion, estimated 2 years
Assistants will maintain counts of participants who complete each study visit.
Proportion of missing data
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Carolinas Comfort Scale Score(Measured at baseline, 48 hours after surgery, 2 weeks after surgery, 6 months after surgery)
- Physical Function Score(Measured at baseline, 48 hours after surgery, 2 weeks after surgery, 6 months after surgery)
- Trail Making Test(Measured at baseline, prior to discharge, 48 hours after discharge, 2 weeks after surgery, 6 months after surgery)
- Montreal Cognitive Assessment(Measured at baseline, prior to discharge, 48 hours after discharge, 2 weeks after surgery, 6 months after surgery)
- Participants with Delirium(Measured at baseline, prior to discharge, 48 hours after discharge, 2 weeks after surgery, 6 months after surgery)
- Pain Level(Measured at baseline, prior to discharge, 48 hours after discharge, 2 weeks after surgery, 6 months after surgery)
- Postoperative complications(Up to 2 weeks)
- Operative time(Time between surgery start and surgery end measured. 1 day of surgery)
- Anesthesia time(Time spent in operating room. 1 day of surgery)
- Recovery time(Time spent in post anesthesia care unit. 1 day of surgery)
- Operative time(Time between surgery start and surgery end measured. 1 day of surgery)
- Postoperative complications(Up to 2 weeks)
- Anesthesia time(Time spent in operating room. 1 day of surgery)
- Recovery time(Time spent in post anesthesia care unit. 1 day of surgery)