Evaluation of the Safety and Efficacy of EXPAREL When Administered Into the TAP in Subjects Undergoing Cesarean Section
NCT02353754 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 12
Last updated 2021-03-26
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).
Conditions
Interventions
- DRUG
-
Intrathecal morphine injection
0.2 mg
- DRUG
-
EXPAREL
266 mg
Sponsors & Collaborators
-
Pacira Pharmaceuticals, Inc
lead INDUSTRY
Principal Investigators
-
Erol Onel, MD · Pacira Pharmaceuticals, Inc
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-05-31
- Primary Completion
- 2015-06-30
- Completion
- 2015-07-31
Countries
- United States
Study Locations
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