Comparing Epidural Versus General Anesthesia for LESS Cholecystectomies

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

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.

Study Overview

• Status: Unknown
• Conditions: Cholelithiasis
• Intervention / Treatment: Procedure: General Anesthesia; Procedure: Epidural Anesthesia

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.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33613
      • Florida Hospital Tampa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A: General Anesthesia; 35 patients will be randomized to receive general anesthesia during their laparoendoscopic single site incision cholecystectomy.	Procedure: General Anesthesia; Patients will be put under general anesthesia for cholecystectomy; Other Names: IV propofol
Active Comparator: Group B: Epidural Anesthesia; 35 patients will be randomized to receive epidural anesthesia during their laparoendoscopic single site incision cholecystectomy.	Procedure: Epidural Anesthesia; Patients will receive Epidural Anesthesia for cholecystectomy; Other Names: Epidural lidocaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post Anesthesia Recovery Score for Ambulatory Patients	PARSAP scores in the post-anesthesia recovery unit	Immediately postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SF-12 Health survey scores	scale of 12-47	Postoperative days 1, 6, 7/8/9 or 10, 30, 90
Pain	VAS 0-10 scale	Immediately postoperative through postoperative day 90
Opioid requirement	Opioid use in milligrams through postoperative day 90 will be recorded.	Preoperative through postoperative day 90

Collaborators and Investigators

• Sponsor: Florida Hospital Tampa Bay Division
• Investigators: Principal Investigator: Sharona Ross, MD, Florida Hospital Tampa; Principal Investigator: Alexander Rosemurgy, MD, Florida Hospital Tampa

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): April 1, 2019

Study Registration Dates

• First Submitted: July 26, 2017
• First Submitted That Met QC Criteria: August 8, 2017
• First Posted (Actual): August 11, 2017

Study Record Updates

• Last Update Posted (Actual): August 11, 2017
• Last Update Submitted That Met QC Criteria: August 8, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathological Conditions, Anatomical; Gallbladder Diseases; Biliary Tract Diseases; Calculi; Gallstones; Cholelithiasis; Cholecystolithiasis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Membrane Transport Modulators; Hypnotics and Sedatives; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Anesthetics; Propofol; Lidocaine
• Other Study ID Numbers: 482717 revised

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No