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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: General Anesthesia | Active Comparator | 35 patients will be randomized to receive general anesthesia during their laparoendoscopic single site incision cholecystectomy. |
|
| Group B: Epidural Anesthesia | Active Comparator | 35 patients will be randomized to receive epidural anesthesia during their laparoendoscopic single site incision cholecystectomy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| General Anesthesia | Procedure | Patients will be put under general anesthesia for cholecystectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Post Anesthesia Recovery Score for Ambulatory Patients | PARSAP scores in the post-anesthesia recovery unit | Immediately postoperative |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sharona Ross, MD | Florida Hospital Tampa | Principal Investigator |
| Alexander Rosemurgy, MD | Florida Hospital Tampa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florida Hospital Tampa | Tampa | Florida | 33613 | United States |
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| ID | Term |
|---|---|
| D002769 | Cholelithiasis |
| ID | Term |
|---|---|
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000768 | Anesthesia, General |
| D015742 | Propofol |
| D000767 | Anesthesia, Epidural |
| ID | Term |
|---|---|
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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| Epidural Anesthesia | Procedure | Patients will receive Epidural Anesthesia for cholecystectomy |
|
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| Opioid requirement | Opioid use in milligrams through postoperative day 90 will be recorded. | Preoperative through postoperative day 90 |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D000765 | Anesthesia, Conduction |