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New combo drug aims to cut opioid use after bunion surgery

NCT ID NCT03295721

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This completed Phase 3 trial tested HTX-011, a combination of bupivacaine and meloxicam, for pain relief after bunionectomy. 412 adults received either HTX-011, a saline placebo, or standard bupivacaine directly into the surgical site. The goal was to see if HTX-011 reduces pain and the need for opioid painkillers in 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 (bupivacaine/meloxicam)
What this could lead to
If it works, this could provide a new option for managing pain after foot surgery while reducing the need for opioid painkillers.
What could go wrong
This is a completed Phase 3 trial, so results are available, but the treatment is only for a specific surgery and may not work for other types of pain. Risks include side effects from the drug combination.

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

412 people

The number who actually took part.

Started

Oct 2017

Finished

Mar 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 primary unilateral, distal, first metatarsal bunionectomy with osteotomy and internal fixation under regional 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: * Has had a contralateral foot bunionectomy in the past 3 months. * Has a planned concurrent surgical procedure (eg, bilateral bunionectomy or collateral procedures on the surgical foot). * 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 any NSAIDs within at least 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. * As per subject history and/or medical records, has active infection or is currently undergoing treatment for Hepatitis B, Hepatitis C, or human immunodeficiency virus (HIV). * Has uncontrolled anxiety, psychiatric, or neurological disorder. * 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, benzodiazepine for anxiety 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.

Bunion 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

  • Anaheim Clinical Trials, LLC

    Anaheim, California, 92801, United States

  • Arizona Research Center

    Phoenix, Arizona, 85059, United States

  • Chesapeake Research Group, LLC

    Pasadena, Maryland, 21122, United States

  • EPIC Medical Research, LLC

    Murray, Utah, 84123, United States

  • Endeavor Clinical Trials

    San Antonio, Texas, 78229, United States

  • Futuro Clinical Trials, LLC

    McAllen, Texas, 78501, United States

  • Hermann Drive Surgical Hospital

    Houston, Texas, 77004, United States

  • Jean Brown Research

    Salt Lake City, Utah, 84124, United States

  • Optimal Research , LLC

    Austin, Texas, 78705, United States

  • Orthopaedic Specialists of North America, PLLC

    Mesa, Arizona, 85206, United States

  • Plano Surgical Hospital

    Plano, Texas, 75093, United States

  • Springhill Medical Center

    Mobile, Alabama, 36608, United States

  • Trovare Clinical Research, Inc.

    Bakersfield, California, 93301, United States

  • Westside Surgical Hospital

    Houston, Texas, 77027, United States

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