drugset / Trial / NCT03176459

Evaluate the Safety and Efficacy of EXPAREL When Administered Via Infiltration Into the TAP vs. Bupivacaine Alone in Subjects Undergoing Elective C-Sections

NCT03176459 ↗

Phase 4 Completed 186 enrolled Pacira Pharmaceuticals, Inc
RandomizedParallel-groupTriple-blindTreatment

Summary

Primary objective: The primary objective of this study is to compare total opioid consumption through 72 hours following EXPAREL+bupivacaine HCl infiltration into the transversus abdominis plane (TAP) after spinal anesthesia to active bupivacaine HCl TAP infiltration after spinal anesthesia in subjects undergoing an elective cesarean section (C-section). Secondary objective: The secondary objectives are to assess efficacy and safety parameters and patient satisfaction.

Timeline

Start
2017-06-01
Primary completion
2018-11-20
Completion
2018-12-04

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bupivacaine Other / unclassified 50 mg Other
Comparator Bupivacaine Other / unclassified 266 mg Other

Indications

No indication recorded.