This is a Phase 2b, randomized, double-blind, saline placebo- and active-controlled, multicenter study in subjects undergoing primary unilateral total knee arthroplasty (TKA) to evaluate the analgesic efficacy, safety, and pharmacokinetics (PK) of HTX-011 administered via infiltration to the surgical site.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
285
HTX-011 (bupivacaine/meloxicam), via instillation
Saline placebo via injection
Bupivacaine HCl without epinephrine
Unnamed facility
Mobile, Alabama, United States
Unnamed facility
Sheffield, Alabama, United States
Mean Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) Pain Intensity Scores at Rest (NRS-R) Through 48 Hours Postsurgery (AUC0-48).
Pain intensity is assessed at rest using an 11-point NRS (0-10) where 0 represents "no pain" and 10 represents "worst pain imaginable" (using windowed worst observation carried forward to adjust for opioid rescue medication use). The theoretical range of AUC0-48 is 0-480.
Time frame: 48 hours
Mean Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) Pain Intensity Scores at Rest (NRS-R) Through 72 Hours Postsurgery (AUC0-72).
Pain intensity is assessed at rest using an 11-point NRS (0-10) where 0 represents "no pain" and 10 represents "worst pain imaginable" (using windowed worst observation carried forward to adjust for opioid rescue medication use). The theoretical range of AUC0-72 is 0-720.
Time frame: 72 hours
Mean Total Postoperative Opioid Consumption (in Morphine Equivalents)
Time frame: 72 hours
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Ropivacaine, via injection
Unnamed facility
Phoenix, Arizona, United States
Unnamed facility
Phoenix, Arizona, United States
Unnamed facility
La Jolla, California, United States
Unnamed facility
Riverside, California, United States
Unnamed facility
San Diego, California, United States
Unnamed facility
Miami, Florida, United States
Unnamed facility
Miami, Florida, United States
Unnamed facility
Miami, Florida, United States
...and 14 more locations