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Study of Post-Herniorrhaphy Non-opioid MMA Regimens
Sponsor: Heron Therapeutics
Summary
This is a Phase 3b, open-label study to assess postoperative opioid use in subjects undergoing unilateral open inguinal herniorrhaphy with intraoperative administration of HTX-011 and a postoperative non-opioid multimodal analgesic (MMA) regimen. The study will be conducted in 2 sequential parts: Part 1 is randomized and Part 2 is Investigator's preference for MMA regimen.
Official title: A Phase 3b, Randomized, Open-Label Study of HTX-011 as the Foundation of a Non-opioid, Multimodal Analgesic Regimen to Decrease Opioid Use Following Unilateral Open Inguinal Herniorrhaphy
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
209
Start Date
2019-04-04
Completion Date
2021-11-22
Last Updated
2026-06-04
Healthy Volunteers
No
Conditions
Interventions
HTX-011
300 mg bupivacaine/9 mg meloxicam
Luer lock applicator
Applicator for instillation
Ibuprofen
600 mg
Acetaminophen
1 g
Locations (30)
Anaheim Clinical Trials, LLC
Anaheim, California, United States
Horizon Clinical Research
La Mesa, California, United States
Sharp Grossmont Hospital
La Mesa, California, United States
University of California, Irvine Medical Center
Orange, California, United States
Parkview Community Hospital
Riverside, California, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Medical Research of Westchester, Inc
Miami, Florida, United States
Professional Health Care of Pinellas
St. Petersburg, Florida, United States
University of Louisville Hospital
Louisville, Kentucky, United States
Baylor University Medical Center
Dallas, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Rutgers - New Jersey Medical School
Newark, New Jersey, United States
Stony Brook University Hospital
Stony Brook, New York, United States
Montefiore Hutchinson Campus
The Bronx, New York, United States
M3 Emerging Medical Research, LLC
Durham, North Carolina, United States
Cleveland Clinic Fairview
Cleveland, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
The Ohio State University Wexner Medical Center - University Hospital
Columbus, Ohio, United States
Midwest Clinical Research Center, LLC
Dayton, Ohio, United States
Summit Medical Group Oregon-Bend Memorial Clinic
Bend, Oregon, United States
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
UPMC Shadyside Hospital
Pittsburgh, Pennsylvania, United States
UPMC Passavant
Pittsburgh, Pennsylvania, United States
Baylor University Medical Center
Dallas, Texas, United States
Hermann Drive Surgical Hospital
Houston, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
Plano Surgical Hospital
Plano, Texas, United States
Endeavor Clinical Trials, LLC
San Antonio, Texas, United States
JBR Clinical Research
Draper, Utah, United States