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New combo drug aims to cut opioid use after hernia surgery

NCT ID NCT03237481

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a drug called HTX-011, which combines two pain relievers (bupivacaine and meloxicam), to see if it can control pain better than standard treatments after hernia surgery. 418 adults having open inguinal hernia repair received either HTX-011, a standard painkiller, or a placebo. The goal was to measure pain levels and how much opioid pain medicine was needed during the first 72 hours 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 (a combination of bupivacaine and meloxicam)
What this could lead to
If it works, this could provide a new option for managing pain after surgery with less need for opioids.
What could go wrong
This is a completed Phase 3 trial, but results may not apply to all surgeries or patients. Pain relief may not be better than existing treatments.

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

418 people

The number who actually took part.

Started

Jul 2017

Finished

Jan 2018

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 to undergo a unilateral open inguinal herniorrhaphy with mesh under general anesthesia. * Has an American Society of Anesthesiologists 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: * Had any prior inguinal hernia repair. * Has a planned concurrent surgical procedure. * Has other 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. * Has known or suspected daily use of opioids for 7 or more consecutive days within the previous 6 months. * Has taken NSAIDs within 10 days prior to the scheduled surgery. * Has taken opioids within 24 hours prior to the scheduled surgery (3 days for long-acting). * Has been administered bupivacaine within 5 days prior to the scheduled surgery. * Has initiated treatment with medications within 1 month prior to study drug administration that can impact pain control. * Has been administered systemic steroids within 5 half-lives or 10 days prior to administration of study drug. * 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. * Has a known history of Hepatitis B, human immunodeficiency virus (HIV), or active Hepatitis C. * Has uncontrolled anxiety, psychiatric, or neurological disorder that, in the opinion of the Investigator, might interfere with study assessments. * Had a malignancy in the last year, with the exception of nonmetastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix. * Has a known or suspected history of drug abuse, a positive drug screen on the day of surgery, or a recent history of alcohol abuse. Note: Subjects with a positive drug screen who are taking an allowed, prescribed medication that is known to result in a positive drug test (eg, amphetamine and dextroamphetamine for attention deficit/hyperactivity disorder) may be eligible for participation in the study. Subjects taking medical marijuana are not allowed to participate in the study. * Received an investigational product or device in a clinical trial within 30 days or within 5 elimination half lives. * Has undergone 3 or more surgeries within 12 months. * Has a body mass index (BMI) \>39 kg/m2.

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Conditions

The condition(s) this trial relates to.

Hernia Hernia, Inguinal Pain, Postoperative

As listed by the trial registrant

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

Postoperative pain

Contacts and locations

Locations

  • Alliance Research Centers

    Laguna Hills, California, 92653, United States

  • American Institute of Research

    Whittier, California, 90603, United States

  • Anaheim Clinical Trials, LLC

    Anaheim, California, 92801, United States

  • Arizona Research Center

    Phoenix, Arizona, 85053, United States

  • Cornerstone Research Institute, LLC

    Longwood, Florida, 32750, United States

  • EPIC Medical Research, LLC

    Murray, Utah, 84123, United States

  • Eliza Coffee Memorial Hospital

    Florence, Alabama, 35630, United States

  • Endeavor Clinical Trials, P.A.

    San Antonio, Texas, 78229, United States

  • HD Research Corp

    Riverside, California, 92503, United States

  • Hermann Drive Surgical Hospital

    Houston, Texas, 77004, United States

  • Jean Brown Research

    Salt Lake City, Utah, 84124, United States

  • Jessa Ziekenhuis

    Hasselt, Limburg, 3500, Belgium

  • Lotus Clinical Research, LLC

    Pasadena, California, 91105, United States

  • Midwest Clinical Research

    Dayton, Ohio, 45417, United States

  • Park Place Surgery Center

    Maitland, Florida, 32751, United States

  • Plano Surgical Hospital

    Plano, Texas, 75093, United States

  • Shoals Medical Trials, Inc.

    Sheffield, Alabama, 35660, United States

  • St. Louis Clinical Trials

    St Louis, Missouri, 63141, United States

  • Trovare Clinical Research, Inc.

    Bakersfield, California, 93301, United States

  • University of Miami

    Miami, Florida, 33136, United States

  • Westside Surgical Hospital

    Houston, Texas, 77027, United States

  • Yale University School of Medicine

    New Haven, Connecticut, 06511, United States

  • Ziekenhuis Oost Limburg

    Genk, 3600, Belgium

  • eStudySite

    Las Vegas, Nevada, 89109, United States

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