Comparing Epidural Versus General Anesthesia for LESS Cholecystectomies

Cholelithiasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03247257
• Other study ID #: 482717 revised
• Status: Enrolling by invitation
• Phase: N/A
• First received: July 26, 2017
• Last updated: August 8, 2017
• Start date: February 2015
• Est. completion date: April 2019

Study information

• Verified date: August 2017
• Source: Florida Hospital Tampa Bay Division
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 70
• Est. completion date: April 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cholecystolithiasis
• Cholelithiasis
• Gallstones

Intervention

Procedure:
• General Anesthesia
Patients will be put under general anesthesia for cholecystectomy
• Epidural Anesthesia
Patients will receive Epidural Anesthesia for cholecystectomy

Locations

Country	Name	City	State
United States	Florida Hospital Tampa	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Florida Hospital Tampa Bay Division

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post Anesthesia Recovery Score for Ambulatory Patients	PARSAP scores in the post-anesthesia recovery unit	Immediately postoperative
Secondary	SF-12 Health survey scores	scale of 12-47	Postoperative days 1, 6, 7/8/9 or 10, 30, 90
Secondary	Pain	VAS 0-10 scale	Immediately postoperative through postoperative day 90
Secondary	Opioid requirement	Opioid use in milligrams through postoperative day 90 will be recorded.	Preoperative through postoperative day 90