This is a Phase 2, open-label study in subjects undergoing unilateral open inguinal herniorrhaphy.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
63
HTX-011 (bupivacaine/meloxicam), 300 mg/ 9 mg via instillation.
Applicator for instillation.
Device for withdrawal of drug product.
Anaheim Clinical Trials, LLC
Anaheim, California, United States
Lotus Clinical Research, LLC
Pasadena, California, United States
JBR Clinical Research
Draper, Utah, United States
JBR Clinical Research
Murray, Utah, United States
Percentage of Subjects Receiving no Opioid Rescue
Time frame: 72 hours
Total Postoperative Opioid Consumption (in IV Morphine Milligram Equivalents [IV MME])
Time frame: 72 hours
Percentge of Subjects Receiving no Opioid Rescue
Time frame: 0-24 hours, 24-48 hours, 24-72 hours, 48-72 hours
Percentge of Subjects Receiving no Opioid Rescue
Time frame: Day 28
Percentge of Subjects in Severe Pain With Numeric Rating Scale (NRS-R; Windowed Worst Observation Carried Forward) of Pain Intensity Scores >7 on a Scale of 0-10 at Any Point. NRS-R for Pain Where 0 Equals no Pain and 10 Equals Worst Pain Imaginable.
Time frame: 72 hours
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Ibuprofen, 600 mg.
Acetaminophen, 1 g.
Intraoperative IV ketorolac.
JBR Clinical Research
Salt Lake City, Utah, United States