Clinical trial NCT03247257: Comparing Epidural Versus General Anesthesia for LESS Cholecystectomies
Official title: Epidural Versus General Anesthesia for Laparoendoscopic Single Site Cholecystectomy: A Prospective, Comparative, Controlled, Blinded Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cholelithiasis
Lead sponsor: Florida Hospital Tampa Bay Division
Sponsor class: OTHER
First posted: 2017-08-11
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Post Anesthesia Recovery Score for Ambulatory Patients
timeFrame: Immediately postoperative
Secondary outcomes:
measure: SF-12 Health survey scores
timeFrame: Postoperative days 1, 6, 7/8/9 or 10, 30, 90
measure: Pain
timeFrame: Immediately postoperative through postoperative day 90
measure: Opioid requirement
timeFrame: Preoperative through postoperative day 90
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Florida Hospital Tampa
state: Florida
Study officials:
affiliation: Florida Hospital Tampa
name: Sharona Ross, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Florida Hospital Tampa
name: Alexander Rosemurgy, MD
role: PRINCIPAL_INVESTIGATOR
References: