Comparing Epidural Versus General Anesthesia for LESS Cholecystectomies

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Epidural Versus General Anesthesia for Laparoendoscopic Single Site Cholecystectomy: A Prospective, Comparative, Controlled, Blinded Study

Conditions
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Cholelithiasis

Intervention / Treatment
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* Procedure: General Anesthesia
* Procedure: Epidural Anesthesia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A: General Anesthesia<br>35 patients will be randomized to receive general anesthesia during their laparoendoscopic single site incision cholecystectomy. | Procedure: General Anesthesia<br>* Patients will be put under general anesthesia for cholecystectomy<br>* Other names: IV propofol;|
| Active Comparator: Group B: Epidural Anesthesia<br>35 patients will be randomized to receive epidural anesthesia during their laparoendoscopic single site incision cholecystectomy. | Procedure: Epidural Anesthesia<br>* Patients will receive Epidural Anesthesia for cholecystectomy<br>* Other names: Epidural lidocaine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post Anesthesia Recovery Score for Ambulatory Patients | PARSAP scores in the post-anesthesia recovery unit | Immediately postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SF-12 Health survey scores | scale of 12-47 | Postoperative days 1, 6, 7/8/9 or 10, 30, 90 | 
| Pain | VAS 0-10 scale | Immediately postoperative through postoperative day 90 | 
| Opioid requirement | Opioid use in milligrams through postoperative day 90 will be recorded. | Preoperative through postoperative day 90 |