drugset / Trial / NCT02179892

Comparison of Exparel to Bupivacaine With Dexamethasone in TAP Block

NCT02179892 ↗

Phase 4 Terminated 9 enrolled Colette Curtis MD
RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to compare the efficacy and duration of bupivacaine extended-release liposome injection (Exparel) versus bupivacaine with dexamethasone in transversus abdominis plane (TAP) blocks for patients undergoing abdominal surgery at Emory University Hospital and Emory University Hospital Midtown. The investigators hypothesize that Exparel will provide greater postoperative pain relief than bupivacaine with dexamethasone. The investigators plan to enroll up to 50 male and female subjects meeting inclusion and exclusion criteria who will be randomized to receive either Exparel (Group 1) or bupivacaine with epinephrine and dexamethasone (Group 2) in the TAP block to achieve at least 22 subjects in each group

Timeline

Start
2014-07
Primary completion
2015-06-06
Completion
2015-06-06

Outcome

Outcome not reported

Stopped (Enrollment): “Inadequate patient population to complete enrollment”

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bupivacaine Other / unclassified 28 ml Other
Comparator Bupivacaine Other / unclassified 266 mg Other
Comparator Dexamethasone Small molecule 8 mg Other
Comparator Acetaminophen Small molecule 650 mg Intravenous
Comparator Acetaminophen Small molecule 1000 mg Intravenous

Indications

No indication recorded.