Study of Post-Herniorrhaphy Non-opioid MMA Regimens

Completed · Phase 3

Conditions studied: Analgesia

In brief

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.

Key facts

Study ID

NCT03907176

Run by

Heron Therapeutics

People needed

209

Starts

2019-04-04

Expected to finish

2021-11-22

Last updated by the study team

2026-06-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Is scheduled and medically fit to undergo an elective unilateral open inguinal herniorrhaphy with mesh under deep sedation or general anesthesia; no neuraxial technique (eg, no spinal or epidural).
• Has an American Society of Anesthesiologists (ASA) Physical Status of I, II, or III.
• Female subjects are eligible only if not pregnant, not lactating, not planning to become pregnant during the study, sterile; or using acceptable contraceptives.

You may not qualify if…

• Has a planned concurrent surgical procedure (eg, bilateral herniorrhaphy).
• Has a pre-existing concurrent acute or chronic painful physical/restrictive condition expected to require analgesic treatment in the postoperative period for pain.
• Has a contraindication or a known or suspected history of hypersensitivity or clinically significant idiosyncratic reaction to required study medications.
• Part 1 only: Has known or suspected daily use of opioids for 7 or more consecutive days within the previous 6 months. Part 2 only: Has known or suspected history of persistent opioid use, defined as daily, or almost daily, use of opioids for a period of at least 30 days within the previous 6 months.
• Has taken any opioids within 24 hours prior to the scheduled surgery.
• Has a known or suspected history of drug abuse, has a positive drug screen on the day of surgery, consumes 3 or more alcoholic drinks every day, or has a recent history of alcohol abuse.
• Has a medical condition such that, in the opinion of the Investigator, participating in the study would pose a health risk to the subject or confound the postoperative assessments .

Where it is running

• 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

Full record on ClinicalTrials.gov

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