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New combo shot may slash opioid use after hernia repair

NCT ID NCT03907176

Symptom relief Sponsor: Heron Therapeutics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether a non-opioid pain regimen, including a long-acting numbing shot (HTX-011) and standard pain relievers like ibuprofen and acetaminophen, could help people avoid opioids after hernia surgery. About 209 adults scheduled for open inguinal hernia repair took part. The main goal was to see how many people did not need an opioid prescription up to 15 days after surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
HTX-011 (ZYNRELEF) – a combination of bupivacaine and meloxicam, plus ibuprofen and acetaminophen
What this could lead to
If successful, this could offer a way to manage pain after hernia surgery without relying on opioids, reducing addiction risk.
What could go wrong
This is an open-label study, so results may be biased. It only looks at one surgery type, and the regimen may not work for everyone or for more painful procedures.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

209 people

The number who actually took part.

Started

Apr 2019

Finished

Nov 2021

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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 .

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Conditions

The condition(s) this trial relates to.

agnosia Hernia Hernia, Inguinal pain agnosia Pain, Postoperative

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Analgesia

Contacts and locations

Locations

  • Anaheim Clinical Trials, LLC

    Anaheim, California, 92801, United States

  • Baylor University Medical Center

    Dallas, Missouri, 75246, United States

  • Baylor University Medical Center

    Dallas, Texas, 75246, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Cleveland Clinic Fairview

    Cleveland, Ohio, 44111, United States

  • Endeavor Clinical Trials, LLC

    San Antonio, Texas, 78229, United States

  • Hermann Drive Surgical Hospital

    Houston, Texas, 77004, United States

  • Horizon Clinical Research

    La Mesa, California, 91942, United States

  • Houston Methodist Hospital

    Houston, Texas, 77030, United States

  • JBR Clinical Research

    Draper, Utah, 84020, United States

  • M3 Emerging Medical Research, LLC

    Durham, North Carolina, 27704, United States

  • Medical Research of Westchester, Inc

    Miami, Florida, 33144, United States

  • Midwest Clinical Research Center, LLC

    Dayton, Ohio, 45417, United States

  • Montefiore Hutchinson Campus

    The Bronx, New York, 10461, United States

  • Parkview Community Hospital

    Riverside, California, 92503, United States

  • Penn Presbyterian Medical Center

    Philadelphia, Pennsylvania, 19104, United States

  • Plano Surgical Hospital

    Plano, Texas, 75093, United States

  • Professional Health Care of Pinellas

    St. Petersburg, Florida, 33713, United States

  • Rutgers - New Jersey Medical School

    Newark, New Jersey, 07103, United States

  • Sharp Grossmont Hospital

    La Mesa, California, 91942, United States

  • Stony Brook University Hospital

    Stony Brook, New York, 11794, United States

  • Summit Medical Group Oregon-Bend Memorial Clinic

    Bend, Oregon, 97701, United States

  • The Ohio State University Wexner Medical Center - University Hospital

    Columbus, Ohio, 43210, United States

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107, United States

  • UPMC Passavant

    Pittsburgh, Pennsylvania, 15237, United States

  • UPMC Shadyside Hospital

    Pittsburgh, Pennsylvania, 15232, United States

  • University of California, Irvine Medical Center

    Orange, California, 92868, United States

  • University of Louisville Hospital

    Louisville, Kentucky, 40202, United States

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

  • Yale University School of Medicine

    New Haven, Connecticut, 06510, United States

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