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Liposomal Bupivicaine arm for Postoperative Pain
N/A
Waitlist Available
Led By David P Gallus, MD
Research Sponsored by United States Naval Medical Center, San Diego
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 2 weeks
Awards & highlights
Study Summary
Aim: To compare the postoperative outcomes after surgical infiltration with plain bupivacaine compared to liposomal bupivacaine in patients undergoing elective, minimally invasive, general surgery procedures. To the investigators knowledge, there are no head-to-head, prospective, randomized, controlled trials of plain bupivacaine versus liposomal bupivacaine to evaluate postoperative pain and return of function.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Post Operative Narcotic Use in Morphine Equivalents
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Liposomal Bupivicaine armExperimental Treatment1 Intervention
Post procedure, infiltrate wounds with liposomal bupivacaine
Liposomal Bupivacaine (Brand name Exparel) 266 milligram (mg)/20 mL to be diluted to 30 mL with normal saline
10 mL of study drug to be injected at each 10-12 millimeter (mm) trocar site and 5 mL of study drug to be injected at the 5 mm trocar sites. Typically there are two 10 mm trocar sites and three 5 mm trocar sites.
Group II: Plain BupivicaineActive Control1 Intervention
Post procedure, infiltrate wounds with plain bupivicaine
Plain Bupivacaine 0.25%, volume of 30 mL
10 mL of study drug to be injected at each 10-12 millimeter (mm) trocar site and 5 mL of study drug to be injected at the 5 mm trocar sites. Typically there are two 10 mm trocar sites and three 5 mm trocar sites.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bupivacaine
FDA approved
Find a Location
Who is running the clinical trial?
United States Naval Medical Center, San DiegoLead Sponsor
102 Previous Clinical Trials
22,656 Total Patients Enrolled
David P Gallus, MDPrincipal InvestigatorUnited States Naval Medical Center, San Diego
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