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Group B: Epidural Anesthesia for Gallstones
N/A
Waitlist Available
Led By Alexander Rosemurgy, MD
Research Sponsored by Florida Hospital Tampa Bay Division
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up preoperative through postoperative day 90
Awards & highlights
Study 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.
Eligible Conditions
- Gallstones
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ postoperative days 1, 6, 7/8/9 or 10, 30, 90
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~postoperative days 1, 6, 7/8/9 or 10, 30, 90
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Post Anesthesia Recovery Score for Ambulatory Patients
Secondary outcome measures
Opioid requirement
Pain
SF-12 Health survey scores
Trial Design
2Treatment groups
Active Control
Group I: Group B: Epidural AnesthesiaActive Control1 Intervention
35 patients will be randomized to receive epidural anesthesia during their laparoendoscopic single site incision cholecystectomy.
Group II: Group A: General AnesthesiaActive Control1 Intervention
35 patients will be randomized to receive general anesthesia during their laparoendoscopic single site incision cholecystectomy.
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Who is running the clinical trial?
Florida Hospital Tampa Bay DivisionLead Sponsor
6 Previous Clinical Trials
520 Total Patients Enrolled
Alexander Rosemurgy, MDPrincipal InvestigatorFlorida Hospital Tampa
2 Previous Clinical Trials
100 Total Patients Enrolled
Sharona Ross, MDPrincipal InvestigatorFlorida Hospital Tampa
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