NCT03247257

Comparing Epidural Versus General Anesthesia for LESS Cholecystectomies

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Florida Hospital Tampa Bay Division · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Cholelithiasis

Interventions

Type	Name	Description
PROCEDURE	General Anesthesia	Patients will be put under general anesthesia for cholecystectomy
PROCEDURE	Epidural Anesthesia	Patients will receive Epidural Anesthesia for cholecystectomy

Timeline

• Start date: 2015-02-01
• Primary completion: 2018-12-01
• Completion: 2019-04-01
• First posted: 2017-08-11
• Last updated: 2017-08-11

Locations

1 site across 1 country: United States