This is a Phase 4, randomized, blinded, active-controlled, multicohort study to evaluate HTX-011 compared with bupivacaine HCl in subjects undergoing Total Shoulder Arthroplasty (TSA) (Cohort 1).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
30
Woodland International Research Group, LLC
Little Rock, Arkansas, United States
Center for Orthopaedic Reconstruction and Excellence
Jenks, Oklahoma, United States
First Surgical Hospital
Bellaire, Texas, United States
Legent Orthopedic Hospital
Carrollton, Texas, United States
Incidence of treatment-emergent adverse events (TEAEs).
Time frame: Through Day 15
Maximum concentration (Cmax) of bupivacaine and meloxicam
Time frame: Through 144 hours
Time of occurrence of maximum concentration (Tmax) of bupivacaine and meloxicam
Time frame: Through 144 hours
Area under the concentration-time curve from Time 0 to the time of the last quantifiable concentration (AUClast) of bupivacaine and meloxicam
Time frame: Through 144 hours
Area under the concentration-time curve from Time 0 extrapolated to infinity (AUCinf) of bupivacaine and meloxicam
Time frame: Through 144 hours
Apparent terminal half-life (t½) of bupivacaine and meloxicam
Time frame: Through 144 hours
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1 g
Applicator for instillation
JBR Clinical Research
Salt Lake City, Utah, United States