drugset / Trial / NCT02353754
Evaluation of the Safety and Efficacy of EXPAREL When Administered Into the TAP in Subjects Undergoing Cesarean Section
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This is a Phase 4, multicenter, open-label study evaluating EXPAREL infiltration into the transversus abdominis plane (TAP) after bupivacaine hydrochloride (HCl) spinal anesthesia in subjects undergoing elective Cesarean section (C-section).
Timeline
- Start
- 2015-05
- Primary completion
- 2015-06
- Completion
- 2015-07
Outcome
Outcome not reported
Stopped (Enrollment): “Slow enrollment. None of the subjects received EXPAREL.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bupivacaine | Other / unclassified | 266 mg | Other |
| Comparator | Morphine | Other / unclassified | 0.2 mg | Intrathecal |
Indications
No indication recorded.