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).
There will be two groups of subjects with approximately 40 subjects per group. Prior to the C-section, all subjects will receive single-shot spinal anesthesia (1.5 mL bupivacaine HCl 0.75% with dextrose 8.25%). Subjects in Group 1 (Standard of Care) will receive intrathecal morphine injection (e.g., Duramorph®) 0.2 mg in conjunction with the single-shot spinal anesthesia. No TAP block will be administered. Subjects in Group 2 (EXPAREL/TAP) will receive a bilateral TAP infiltration with a single 20 mL dose of EXPAREL 266 mg expanded in volume with 20 mL of normal saline for a total volume of 40 mL (20 mL infiltrated on each side of the abdomen).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
0.2 mg
266 mg
Tradition Medical Center
Port Saint Lucie, Florida, United States
University Of Minnesota
Minneapolis, Minnesota, United States
Saint Peter's University Hospital
New Brunswick, New Jersey, United States
Montefiore
The Bronx, New York, United States
Total Postsurgical Narcotic Consumption in Morphine Equivalents
Outcome measure data refer to 7 participants who received rescue medication
Time frame: Through 72 hours postdose
Total Postsurgical Narcotic Consumption in Morphine Equivalents
Outcome measure data refer to 6 participants who received rescue medication
Time frame: Through 24 hours
Total Postsurgical Narcotic Consumption in Morphine Equivalents
Outcome measure data refer to 7 participants who received rescue medication
Time frame: Through 48 hours
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The Ohio State University, Wexner Medical Center
Columbus, Ohio, United States