This is a Phase 4, randomized, open-label study of bupivacaine HCl administered either by instillation into the surgical site or by injection into the surgical site in subjects undergoing bilateral submuscular augmentation mammoplasty under general anesthesia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Bupivacaine HCl without epinephrine 0.25%, 60 mL (30 mL per pectoral pocket)
Hermann Drive Surgical Hospital
Houston, Texas, United States
Maximum Observed Plasma Concentration (Cmax)
Time frame: Baseline through 72 hours after start of study drug administration
Area Under the Concentration-time Curve From Time 0 to the Last Collection Time After Study Drug Administration (AUC Last)
Time frame: Baseline through 72 hours after start of study drug administration
Area Under the Concentration-time Curve From Time 0 to Infinity After Study Drug Administration (AUC∞)
Time frame: Baseline through 72 hours after start of study drug administration
Time to Maximum Plasma Concentration (Tmax)
Time frame: Baseline through 72 hours after start of study drug administration
The Apparent Terminal Elimination Rate Constant (λz)
Time frame: Baseline through 72 hours after start of study drug administration
The Apparent Terminal Elimination Half-life (t1/2el)
Time frame: Baseline through 72 hours after start of study drug administration
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