Epidural Versus General Anesthesia for Laparoendoscopic Single Site Cholecystectomy: A Prospective, Comparative, Controlled, Blinded Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Post Anesthesia Recovery Score for Ambulatory Patients
研究概览
简要总结
This study is a prospective, comparative, controlled, blinded study that will enroll a total of 70 adults that will undergo elective laparoendoscopic single-site incision gallbladder removal. The objective of this study is to compare Epidural versus General Anesthesia for postoperative pain, length of hospital stay, outcomes, and cost of post-cholecystectomy patients.
详细描述
This is a prospective, comparative, controlled, blinded study that will enroll a total of 70 adult patients that require an elective cholecystectomy.
Patients will be randomized 1:1 to receive either general anesthesia (Group A) or epidural anesthesia (Group B) for their laparoendoscopic single site incision (LESS) gallbladder removal surgery (cholecystectomy). Randomization will be achieved using a computer-generated list. The patient will know what are they are randomized to before entering the operating room because an epidural will need to be placed preoperatively. Standards for basic anesthetic monitoring approved by the American Society of Anesthesiologists will occur intraoperatively.
Postoperative evaluations will be completed by a medical professional that is blinded to the type of anesthesia used during the LESS surgery. Postoperative evaluations include a physical exam, adverse events, medication administration, vital signs and post-anesthesia recovery score for ambulatory patients (PARSAP) scores will be taken every 15 minutes until the patient has a score of at least 18.
Patients will be followed 90 days postoperatively to collect pain scores, analgesic use, adverse events, and quality of life questionnaires.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 18 and 65 years of age
- •ASA I or II
- •Patient has a diagnosis of biliary colic with documented cholecystitis, symptomatic gallstones, polyps by imaging or biliary dyskinesia with documented EF < 30%
- •No cardiopulmonary disease
- •Normal coagulation profile
排除标准
- •Any female patient, who is pregnant, suspected pregnant, or nursing
- •Contraindication for pneumoperitoneum
- •Contraindication for epidural anesthesia
- •Allergy to local anesthetic agents
- •Any patient with acute calculus or acalculous cholecystitis
- •Any patient who has had an upper midline or right sub costal incision
- •Any patient with preoperative indication for a cholangiogram
- •Any patient with ASA ≥ 3
- •Any patient who is undergoing Peritoneal Dialysis (PD)
- •History of long term analgesic use requiring pain management (>1 week)
- •Any patient who has an unrepaired umbilical hernia or has had prior umbilical hernia repair
- •Any patient with obstructive sleep apnea (OSA), history of OSA or at high risk of OSA as determined by the STOP Questionnaire
- •BMI > 35 kg/m2
- •Any patient with a history of severe, uncontrolled GERD
研究组 & 干预措施
Group A: General Anesthesia
35 patients will be randomized to receive general anesthesia during their laparoendoscopic single site incision cholecystectomy.
干预措施: General Anesthesia (Procedure)
Group B: Epidural Anesthesia
35 patients will be randomized to receive epidural anesthesia during their laparoendoscopic single site incision cholecystectomy.
干预措施: Epidural Anesthesia (Procedure)
结局指标
主要结局
Post Anesthesia Recovery Score for Ambulatory Patients
时间窗: Immediately postoperative
PARSAP scores in the post-anesthesia recovery unit
次要结局
- SF-12 Health survey scores(Postoperative days 1, 6, 7/8/9 or 10, 30, 90)
- Opioid requirement(Preoperative through postoperative day 90)
- Pain(Immediately postoperative through postoperative day 90)
研究者
Alexander Rosemurgy
Director Surgical Digestive Disorders and GERD Center
Florida Hospital Tampa Bay Division