Comparing Epidural Versus General Anesthesia for LESS Cholecystectomies

Status unconfirmed · Not applicable

Conditions studied: Cholelithiasis

In brief

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.

Key facts

Study ID

NCT03247257

Run by

Florida Hospital Tampa Bay Division

People needed

70

Starts

2015-02-01

Expected to finish

2019-04-01

Last updated by the study team

2017-08-11

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Florida Hospital Tampa — Tampa, Florida, United States

Full record on ClinicalTrials.gov

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