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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Enrollment
70
Patients will be put under general anesthesia for cholecystectomy
Patients will receive Epidural Anesthesia for cholecystectomy
Florida Hospital Tampa
Tampa, Florida, United States
Post Anesthesia Recovery Score for Ambulatory Patients
PARSAP scores in the post-anesthesia recovery unit
Time frame: Immediately postoperative
SF-12 Health survey scores
scale of 12-47
Time frame: Postoperative days 1, 6, 7/8/9 or 10, 30, 90
Pain
VAS 0-10 scale
Time frame: Immediately postoperative through postoperative day 90
Opioid requirement
Opioid use in milligrams through postoperative day 90 will be recorded.
Time frame: Preoperative through postoperative day 90
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