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Cohort 2 (Abdominoplasty) of: A Multi-surgery Assessment of ZYNRELEF (HTX-011)
Sponsor: Heron Therapeutics
Summary
Cohort 2 (subjects undergoing abdominoplasty) of a Phase 4, randomized, blinded, active-controlled, multicohort study to evaluate HTX-011 compared with bupivacaine HCl in subjects undergoing different surgical procedures See also the separate record for the master study protocol (NCT05109312).
Official title: A Phase 4, Randomized, Blinded, Active-Controlled Study of HTX-011 in Subjects Undergoing Different Surgical Procedures, Cohort 2: Abdominoplasty
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
37
Start Date
2021-10-12
Completion Date
2022-04-07
Last Updated
2026-10-28
Healthy Volunteers
No
Interventions
MMA regimen
acetaminophen 1 g every 8 hours (q8h) and ibuprofen 400 mg q8h, alternating the 2 medications so that an analgesic was taken approximately every 4 hours (q4h)
ZYNRELEF kit components for administration
ZYNRELEF kits include sterile, individually packaged components for administration, including vented vial spikes, Luer lock syringes, custom Luer lock applicators, and syringe tip caps.
HTX-011
HTX-011 (bupivacaine/meloxicam) extended-release solution for instillation use, supplied in commercially available ZYNRELEF kits
Bupivacaine Hydrochloride
Bupivacaine HCl (without epinephrine) 0.25%
Locations (2)
First Surgical Hospital
Bellaire, Texas, United States
Endeavor Clinical Trials, LLC
San Antonio, Texas, United States