Status:
UNKNOWN
Comparing Epidural Versus General Anesthesia for LESS Cholecystectomies
Lead Sponsor:
Florida Hospital Tampa Bay Division
Conditions:
Cholelithiasis
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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 obje...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2019
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT03247257
Start Date
February 1 2015
End Date
April 1 2019
Last Update
August 11 2017
Active Locations (1)
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1
Florida Hospital Tampa
Tampa, Florida, United States, 33613