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COMPLETED
NCT06109428
PHASE4

Cohort 2 (Abdominoplasty) of: A Multi-surgery Assessment of ZYNRELEF (HTX-011)

Sponsor: Heron Therapeutics

View on ClinicalTrials.gov

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

DRUG

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)

DEVICE

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.

DRUG

HTX-011

HTX-011 (bupivacaine/meloxicam) extended-release solution for instillation use, supplied in commercially available ZYNRELEF kits

DRUG

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