Cholelithiasis
Conditions
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.
Interventions
PROCEDUREGeneral Anesthesia
Patients will be put under general anesthesia for cholecystectomy
PROCEDUREEpidural Anesthesia
Patients will receive Epidural Anesthesia for cholecystectomy
Sponsors
Florida Hospital Tampa Bay Division
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post Anesthesia Recovery Score for Ambulatory Patients | Immediately postoperative | PARSAP scores in the post-anesthesia recovery unit |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SF-12 Health survey scores | Postoperative days 1, 6, 7/8/9 or 10, 30, 90 | scale of 12-47 |
| Pain | Immediately postoperative through postoperative day 90 | VAS 0-10 scale |
| Opioid requirement | Preoperative through postoperative day 90 | Opioid use in milligrams through postoperative day 90 will be recorded. |
Countries
United States
Outcome results
None listed