AnalgesiaPhase 3NCT03907176
Study of Post-Herniorrhaphy Non-opioid MMA Regimens
A Phase 3 study testing HTX-011, Luer lock applicator and Ibuprofen in people with Analgesia, run by Heron Therapeutics at 30 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Analgesia
- What is being tested?
- HTX-011, Luer lock applicator and Ibuprofen
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 209 participants
- Where
- 30 sitesUnited States
- Study dates
- 4 Apr 2019to 22 Nov 2021
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 .
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
United States30 sites
Anaheim Clinical Trials, LLC
Anaheim, California, 92801
Summit Medical Group Oregon-Bend Memorial Clinic
Bend, Oregon, 97701
Cleveland Clinic Fairview
Cleveland, Ohio, 44111
Cleveland Clinic
Cleveland, Ohio, 44195
The Ohio State University Wexner Medical Center - University Hospital
Columbus, Ohio, 43210
Baylor University Medical Center
Dallas, Missouri, 75246
Baylor University Medical Center
Dallas, Texas, 75246
Midwest Clinical Research Center, LLC
Dayton, Ohio, 45417
JBR Clinical Research
Draper, Utah, 84020
M3 Emerging Medical Research, LLC
Durham, North Carolina, 27704
Hermann Drive Surgical Hospital
Houston, Texas, 77004
Houston Methodist Hospital
Houston, Texas, 77030
Horizon Clinical Research
La Mesa, California, 91942
Sharp Grossmont Hospital
La Mesa, California, 91942
University of Louisville Hospital
Louisville, Kentucky, 40202
Medical Research of Westchester, Inc
Miami, Florida, 33144
Yale University School of Medicine
New Haven, Connecticut, 06510
Rutgers - New Jersey Medical School
Newark, New Jersey, 07103
University of California, Irvine Medical Center
Orange, California, 92868
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
UPMC Shadyside Hospital
Pittsburgh, Pennsylvania, 15232
UPMC Passavant
Pittsburgh, Pennsylvania, 15237
Plano Surgical Hospital
Plano, Texas, 75093
Parkview Community Hospital
Riverside, California, 92503
Endeavor Clinical Trials, LLC
San Antonio, Texas, 78229
Washington University School of Medicine
St Louis, Missouri, 63110
Professional Health Care of Pinellas
St. Petersburg, Florida, 33713
Stony Brook University Hospital
Stony Brook, New York, 11794
Montefiore Hutchinson Campus
The Bronx, New York, 10461
About this study
Official title: A Phase 3b, Randomized, Open-Label Study of HTX-011 as the Foundation of a Non-opioid, Multimodal Analgesic Regimen to Decrease Opioid Use Following Unilateral Open Inguinal Herniorrhaphy
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.
- Conditions
- Analgesia
- Being tested
- HTX-011, Luer lock applicator, Ibuprofen, Acetaminophen
- Keywords
- inguinal hernia, hernia, hernia surgery, postoperative pain, herniorrhaphy, multimodal analgesia
- Medical subject headings
- Agnosia, Hernia, Inguinal, Hernia, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HTX-011Drug
Also called ZYNRELEF
300 mg bupivacaine/9 mg meloxicam
Luer lock applicatorDevice
Applicator for instillation
IbuprofenDrug
600 mg
AcetaminophenDrug
1 g
| Study group | Role | What they receive |
|---|---|---|
| HTX-011 + Alternating MMA Regimen | Experimental | HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen of ibuprofen and acetaminophen, alternating (one or the other every 3 hours), while awake. Receives: Drug: HTX-011; Device: Luer lock applicator; Drug: Ibuprofen; Drug: Acetaminophen |
| HTX-011 + Concurrent MMA Regimen | Experimental | HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen of ibuprofen and acetaminophen, together every 6 hours, while awake. Receives: Drug: HTX-011; Device: Luer lock applicator; Drug: Ibuprofen; Drug: Acetaminophen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Subjects Who do Not Receive an Opioid Prescription Through the Day 15 Visit
Measured: Through Day 15
Secondary outcomes (5)
Proportion of Subjects Who do Not Receive an Opioid Prescription at Discharge
Proportion of subjects who do not receive an opioid prescription at discharge (between 2 and 3 hours after surgery on average).
Measured: At discharge
Proportion of Subjects Who do Not Receive a Postdischarge Opioid Prescription, Through the Day 15 Visit.
Measured: Postdischarge through Day 15
Pain Intensity Scores at the Time of Discharge
Pain intensity scores were assessed at discharge (between 2 and 3 hours after surgery on average) using an 11-point Numeric Rating Scale (NRS) (0-10) where 0 represents "no pain" and 10 represents "worst pain imaginable". NRS scores are recorded with activity (NRS-A), sitting up from a resting position.
Measured: At discharge
Number of Oxycodone Pills Taken Between Discharge and the Day 15 Visit
Measured: Postdischarge through Day 15
Mean TSQM-9 Scores
The TSQM-9 contains 9 items which make up the Effectiveness, Convenience, and Global Satisfaction domains; each domain includes 3 items. Scores for each domain were computed by adding the TSQM items in each domain and then transforming the composite score into a value ranging from 0 to 100, with higher scores indicating higher satisfaction.
Measured: Day 15 plus or minus 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2019
- Study start4 Apr 2019
- Primary completion25 Oct 2021
- Study completion22 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- In Part 1, subjects will be randomized to one of the 2 parallel postoperative MMA regimens. In Part 2, the Investigator will select one of the 2 postoperative MMA regimens, based on Investigator and/or subject preference.
- Masking
- None (open label)
- Enrolment
- 209 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heron Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03907176
- Sponsor's protocol ID
- HTX-011-304
- Status last verified
- May 2026
- First submitted
- 5 Apr 2019
- Last updated
- 4 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3b, Randomized, Open-Label Study of HTX-011 as the Foundation of a Non-opioid, Multimodal Analgesic Regimen to Decrease Opioid Use Following Unilateral Open Inguinal Herniorrhaphy
- ClinicalTrials.gov ID
- NCT03907176
- Acronym / sponsor ID
- HTX-011-304
- Conditions
- Analgesia
- Keywords
- inguinal hernia, hernia, hernia surgery, postoperative pain, herniorrhaphy, multimodal analgesia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 209 participants (actual)
- Lead sponsor
- Heron TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 4 Apr 2019 (actual)
- Primary completion
- 25 Oct 2021 (actual)
- Study completion
- 22 Nov 2021 (actual)
- First posted
- 8 Apr 2019 (actual)
- Results
- Posted 4 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In Part 1, subjects will be randomized to one of the 2 parallel postoperative MMA regimens. In Part 2, the Investigator will select one of the 2 postoperative MMA regimens, based on Investigator and/or subject preference.
| Arm | Type | Receives |
|---|---|---|
| HTX-011 + Alternating MMA Regimen | Experimental | Drug: HTX-011, Device: Luer lock applicator, Drug: Ibuprofen, Drug: AcetaminophenHTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen of ibuprofen and acetaminophen, alternating (one or the other every 3 hours), while awake. |
| HTX-011 + Concurrent MMA Regimen | Experimental | Drug: HTX-011, Device: Luer lock applicator, Drug: Ibuprofen, Drug: AcetaminophenHTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen of ibuprofen and acetaminophen, together every 6 hours, while awake. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HTX-011Also: ZYNRELEF300 mg bupivacaine/9 mg meloxicam | Drug | HTX-011 + Alternating MMA Regimen, HTX-011 + Concurrent MMA Regimen |
| Luer lock applicatorApplicator for instillation | Device | HTX-011 + Alternating MMA Regimen, HTX-011 + Concurrent MMA Regimen |
| Ibuprofen600 mg | Drug | HTX-011 + Alternating MMA Regimen, HTX-011 + Concurrent MMA Regimen |
| Acetaminophen1 g | Drug | HTX-011 + Alternating MMA Regimen, HTX-011 + Concurrent MMA Regimen |
Primary outcome
Proportion of Subjects Who do Not Receive an Opioid Prescription Through the Day 15 Visit
Time frame: Through Day 15
5 secondary outcomes
Proportion of Subjects Who do Not Receive an Opioid Prescription at Discharge
Time frame: At discharge
Proportion of Subjects Who do Not Receive a Postdischarge Opioid Prescription, Through the Day 15 Visit.
Time frame: Postdischarge through Day 15
Pain Intensity Scores at the Time of Discharge
Time frame: At discharge
Number of Oxycodone Pills Taken Between Discharge and the Day 15 Visit
Time frame: Postdischarge through Day 15
Mean TSQM-9 Scores
Time frame: Day 15 plus or minus 2 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HTX-011, Luer lock applicator and Ibuprofen in people with Analgesia, run by Heron Therapeutics at 30 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Subjects Who do Not Receive an Opioid Prescription Through the Day 15 Visit (time frame: Through Day 15). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.