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
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Bupivacaine | Other / unclassified | 50 mg | Other |
| Comparator | Bupivacaine | Other / unclassified | 266 mg | Other |
Indications
No indication recorded.