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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
115
Proportion of subjects who do not receive an opioid prescription at discharge through the day 15 visit
Time frame: Discharge through Day 15
Proportion of subjects who do not receive an opioid prescription at discharge
Time frame: At discharge
Proportion of subjects who do not receive a postdischarge opioid prescription, through the Day 15 visit.
Time frame: Postdischarge through Day 15
Pain intensity scores at the time of discharge
Time frame: At discharge
Number of oxycodone pills taken between discharge and the Day 15 visit
Time frame: Postdischarge through Day 15
Mean TSQM-9 scores
Time frame: Day 15 plus or minus 2 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
1 g
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
...and 20 more locations