Comparing Epidural Versus General Anesthesia for LESS Cholecystectomies
Primary Purpose
Cholelithiasis
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
General Anesthesia
Epidural Anesthesia
Sponsored by
About this trial
This is an interventional health services research trial for Cholelithiasis
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
Sites / Locations
- Florida Hospital Tampa
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group A: General Anesthesia
Group B: Epidural Anesthesia
Arm Description
35 patients will be randomized to receive general anesthesia during their laparoendoscopic single site incision cholecystectomy.
35 patients will be randomized to receive epidural anesthesia during their laparoendoscopic single site incision cholecystectomy.
Outcomes
Primary Outcome Measures
Post Anesthesia Recovery Score for Ambulatory Patients
PARSAP scores in the post-anesthesia recovery unit
Secondary Outcome Measures
SF-12 Health survey scores
scale of 12-47
Pain
VAS 0-10 scale
Opioid requirement
Opioid use in milligrams through postoperative day 90 will be recorded.
Full Information
NCT ID
NCT03247257
First Posted
July 26, 2017
Last Updated
August 8, 2017
Sponsor
Florida Hospital Tampa Bay Division
1. Study Identification
Unique Protocol Identification Number
NCT03247257
Brief Title
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
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
February 2015 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
April 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Florida Hospital Tampa Bay Division
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholelithiasis
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A: General Anesthesia
Arm Type
Active Comparator
Arm Description
35 patients will be randomized to receive general anesthesia during their laparoendoscopic single site incision cholecystectomy.
Arm Title
Group B: Epidural Anesthesia
Arm Type
Active Comparator
Arm Description
35 patients will be randomized to receive epidural anesthesia during their laparoendoscopic single site incision cholecystectomy.
Intervention Type
Procedure
Intervention Name(s)
General Anesthesia
Other Intervention Name(s)
IV propofol
Intervention Description
Patients will be put under general anesthesia for cholecystectomy
Intervention Type
Procedure
Intervention Name(s)
Epidural Anesthesia
Other Intervention Name(s)
Epidural lidocaine
Intervention Description
Patients will receive Epidural Anesthesia for cholecystectomy
Primary Outcome Measure Information:
Title
Post Anesthesia Recovery Score for Ambulatory Patients
Description
PARSAP scores in the post-anesthesia recovery unit
Time Frame
Immediately postoperative
Secondary Outcome Measure Information:
Title
SF-12 Health survey scores
Description
scale of 12-47
Time Frame
Postoperative days 1, 6, 7/8/9 or 10, 30, 90
Title
Pain
Description
VAS 0-10 scale
Time Frame
Immediately postoperative through postoperative day 90
Title
Opioid requirement
Description
Opioid use in milligrams through postoperative day 90 will be recorded.
Time Frame
Preoperative through postoperative day 90
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharona Ross, MD
Organizational Affiliation
Florida Hospital Tampa
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alexander Rosemurgy, MD
Organizational Affiliation
Florida Hospital Tampa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Florida Hospital Tampa
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Comparing Epidural Versus General Anesthesia for LESS Cholecystectomies
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