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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
Age: 18 years or older
ASA status 1, 2 or 3
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks for reporting.

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Trial of Liposomal Versus Plain Bupivacaine in Minimally Invasive General Surgery Procedures
2015. "Trial of Liposomal Versus Plain Bupivacaine in Minimally Invasive General Surgery Procedures". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02875288.
All > Exparel
~6 spots leftby Apr 2025
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