New drug cocktail aims to slash opioid use after hernia surgery
NCT ID NCT03695367
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This Phase 2 trial tested a drug called HTX-011 (a mix of bupivacaine and meloxicam) in 63 adults having open inguinal hernia repair. The goal was to see if this painkiller combo, along with other non-opioid medicines, could reduce the need for opioid painkillers after surgery. The study is complete, and researchers measured how many people needed no opioids at all.
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 offer a way to manage pain after hernia surgery with fewer opioids, reducing addiction risk.
- What could go wrong
- This is an early Phase 2 trial with only 63 people, so results may not apply to everyone. The drug's safety and effectiveness are still being studied.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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63 people
The number who actually took part.
- Started
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Oct 2018
- Finished
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Dec 2018
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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 except as a child (less than 6 years of age). * 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. * Has known or suspected daily use of opioids for 7 or more consecutive days within the previous 6 months. * Has taken any NSAIDs within least 10 days prior to the scheduled surgery. * Has taken long-acting opioids within 3 days prior to the scheduled surgery. * Has taken any opioids within 24 hours prior to the scheduled surgery. * Has been administered bupivacaine within 5 days prior to the scheduled surgery. * Has been administered any local anesthetic within 72 hours prior to the scheduled surgery. * Has initiated treatment with study 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 at the discretion of the Sponsor. Subjects taking any marijuana (medical or recreational) are not allowed to participate in the study. * Previously participated in an HTX-011 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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Anaheim Clinical Trials, LLC
Anaheim, California, 92801, United States
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JBR Clinical Research
Draper, Utah, 84020, United States
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JBR Clinical Research
Murray, Utah, 84107, United States
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JBR Clinical Research
Salt Lake City, Utah, 84124, United States
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Lotus Clinical Research, LLC
Pasadena, California, 91105, United States
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