Comparing Epidural Versus General Anesthesia for LESS Cholecystectomies

NCT ID: NCT03247257

Last Updated: 2017-08-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2019-04-30

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 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Group A: General Anesthesia

35 patients will be randomized to receive general anesthesia during their laparoendoscopic single site incision cholecystectomy.

Group Type: ACTIVE_COMPARATOR

General Anesthesia

Intervention Type: PROCEDURE

Patients will be put under general anesthesia for cholecystectomy

Group B: Epidural Anesthesia

35 patients will be randomized to receive epidural anesthesia during their laparoendoscopic single site incision cholecystectomy.

Group Type: ACTIVE_COMPARATOR

Epidural Anesthesia

Intervention Type: PROCEDURE

Patients will receive Epidural Anesthesia for cholecystectomy

Interventions

General Anesthesia

Patients will be put under general anesthesia for cholecystectomy

Intervention Type: PROCEDURE

Epidural Anesthesia

Patients will receive Epidural Anesthesia for cholecystectomy

Intervention Type: PROCEDURE

Other Intervention Names

IV propofol; Epidural lidocaine

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Florida Hospital Tampa Bay Division

OTHER

Sponsor Role: lead

Responsible Party

Alexander Rosemurgy

Director Surgical Digestive Disorders and GERD Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sharona Ross, MD

Role: PRINCIPAL_INVESTIGATOR

Florida Hospital Tampa

Alexander Rosemurgy, MD

Role: PRINCIPAL_INVESTIGATOR

Florida Hospital Tampa

Locations

Florida Hospital Tampa

Tampa, Florida, United States

Countries

United States

Other Identifiers

482717 revised

Identifier Type: -

Identifier Source: org_study_id