Postoperative PainPhase 2NCT03718039
Phase 2 Bunionectomy HTX-011 Administration Study
A Phase 2 study testing HTX-011, Luer Lock applicator and Vial access device in people with Postoperative Pain, run by Heron Therapeutics at 1 site in United States.
Trial summary
This is a Phase 2, open-label, multi-cohort study to evaluate the analgesic efficacy, safety, and pharmacokinetics (PK) of a single, individualized dose of HTX-011 administered into the surgical site as a monotherapy or with other medications to enhance analgesia in subjects undergoing unilateral simple bunionectomy. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- HTX-011, Luer Lock applicator and Vial access device
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Oct 2018to 11 Mar 2019
- Phase
- Phase 2
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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. For cohort 2, acceptable contraceptives excludes hormonal contraceptives.
Who cannot join
- Has had a contralateral foot bunionectomy in the past 3 months prior to the scheduled surgery.
- Has a planned concurrent surgical procedure (eg, bilateral bunionectomy or collateral procedures on the surgical foot).
- 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 at least 10 days prior to the scheduled surgery.
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- 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.
- For Cohort 2 only, has been administered aprepitant or another NK1 receptor antagonist 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.
- For Cohort 2 only, is receiving pimozide, a strong or moderate CYP3A4 inhibitor, or a strong CYP3A4 inducer.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Endeavor Clinical Trials, LLC
San Antonio, Texas, 78229
About this study
Official title: A Phase 2 Open-Label Study of HTX-011 Via Individualized Dosing Administration for Postoperative Analgesia Following Unilateral Simple Bunionectomy
This is a Phase 2, open-label, multi-cohort study to evaluate the analgesic efficacy, safety, and pharmacokinetics (PK) of a single, individualized dose of HTX-011 administered into the surgical site as a monotherapy or with other medications to enhance analgesia in subjects undergoing unilateral simple bunionectomy.
- Conditions
- Postoperative Pain
- Being tested
- HTX-011, Luer Lock applicator, Vial access device, aprepitant
- Keywords
- bunion, bunionectomy, bunion surgery, postoperative pain
- Medical subject headings
- Pain, Postoperative, Bunion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HTX-011Drug
HTX-011 (bupivacaine/meloxicam), up to but not to exceed 60 mg/1.8 mg, via instillation.
Luer Lock applicatorDevice
Applicator for instillation.
Vial access deviceDevice
Device for withdrawal of drug product.
aprepitantDrug
Aprepitant, three single doses of aprepitant will be administered orally.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group 1: HTX-011 | Experimental | HTX-011 (bupivacaine/meloxicam), up to but not to exceed 60 mg/1.8 mg, via instillation. Receives: Drug: HTX-011; Device: Luer Lock applicator; Device: Vial access device |
| Treatment Group 2: HTX-011 + Aprepitant | Experimental | HTX-011 (bupivacaine/meloxicam), up to but not to exceed 60 mg/1.8 mg, via instillation; Aprepitant, three single doses of aprepitant will be administered orally. Receives: Drug: HTX-011; Device: Luer Lock applicator; Device: Vial access device; Drug: aprepitant |
| Treatment Group 3: HTX-011 + Non-Opioid MMA Regimen | Experimental | HTX-011 (bupivacaine/meloxicam), up to but not to exceed 60 mg/1.8 mg, via instillation and a scheduled multimodal analgesic (MMA) regimen. Receives: Drug: HTX-011; Device: Luer Lock applicator; Device: Vial access device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Area Under the Curve (AUC) of the NRS-A (Windowed Worst Observation Carried Forward) Pain Intensity Scores
Pain intensity scores are assessed 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 with the plantar surface of the ball of the surgically attended foot touching the floor (no weight-bearing).
Measured: 72 hours
Secondary outcomes (4)
Mean Total Postoperative Opioid Consumption (in Morphine Equivalents) Through 72 Hours
Measured: 72 hours
Percentage of Subjects Receiving no Opioid Rescue
Measured: 72 hours
Percentage of Subjects Receiving no Opioid Rescue
Only subjects in Cohort 3 received a scheduled, non-opioid MMA regimen following surgery.
Measured: Day 7 and Day 28
Mean Area Under the Curve (AUC) of the NRS-R (Windowed Worst Observation Carried Forward) Pain Intensity Scores
Pain intensity scores are assessed using an 11-point Numeric Rating Scale (NRS) (0-10) where 0 represents "no pain" and 10 represents "worst pain imaginable". NRS scores are measured at rest.
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2018
- Study start24 Oct 2018
- Primary completion31 Jan 2019
- Study completion11 Mar 2019
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 Postoperative PainStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 78 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
- NCT03718039
- Sponsor's protocol ID
- HTX-011-218
- Status last verified
- Feb 2026
- First submitted
- 22 Oct 2018
- Last updated
- 2 Mar 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 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Open-Label Study of HTX-011 Via Individualized Dosing Administration for Postoperative Analgesia Following Unilateral Simple Bunionectomy
- ClinicalTrials.gov ID
- NCT03718039
- Acronym / sponsor ID
- HTX-011-218
- Conditions
- Postoperative Pain
- Keywords
- bunion, bunionectomy, bunion surgery, postoperative pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Heron TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 24 Oct 2018 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 11 Mar 2019 (actual)
- First posted
- 24 Oct 2018 (actual)
- Results
- Posted 26 Jun 2023
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 2, open-label, multi-cohort study to evaluate the analgesic efficacy, safety, and pharmacokinetics (PK) of a single, individualized dose of HTX-011 administered into the surgical site as a monotherapy or with other medications to enhance analgesia in subjects undergoing unilateral simple bunionectomy.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment Group 1: HTX-011 | Experimental | Drug: HTX-011, Device: Luer Lock applicator, Device: Vial access deviceHTX-011 (bupivacaine/meloxicam), up to but not to exceed 60 mg/1.8 mg, via instillation. |
| Treatment Group 2: HTX-011 + Aprepitant | Experimental | Drug: HTX-011, Device: Luer Lock applicator, Device: Vial access device, Drug: aprepitantHTX-011 (bupivacaine/meloxicam), up to but not to exceed 60 mg/1.8 mg, via instillation; Aprepitant, three single doses of aprepitant will be administered orally. |
| Treatment Group 3: HTX-011 + Non-Opioid MMA Regimen | Experimental | Drug: HTX-011, Device: Luer Lock applicator, Device: Vial access deviceHTX-011 (bupivacaine/meloxicam), up to but not to exceed 60 mg/1.8 mg, via instillation and a scheduled multimodal analgesic (MMA) regimen. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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. For cohort 2, acceptable contraceptives excludes hormonal contraceptives.
Key exclusion criteria (23 listed)
- Has had a contralateral foot bunionectomy in the past 3 months prior to the scheduled surgery.
- Has a planned concurrent surgical procedure (eg, bilateral bunionectomy or collateral procedures on the surgical foot).
- 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.
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-011HTX-011 (bupivacaine/meloxicam), up to but not to exceed 60 mg/1.8 mg, via instillation. | Drug | Treatment Group 1: HTX-011, Treatment Group 2: HTX-011 + Aprepitant, Treatment Group 3: HTX-011 + Non-Opioid MMA Regimen |
| Luer Lock applicatorApplicator for instillation. | Device | Treatment Group 1: HTX-011, Treatment Group 2: HTX-011 + Aprepitant, Treatment Group 3: HTX-011 + Non-Opioid MMA Regimen |
| Vial access deviceDevice for withdrawal of drug product. | Device | Treatment Group 1: HTX-011, Treatment Group 2: HTX-011 + Aprepitant, Treatment Group 3: HTX-011 + Non-Opioid MMA Regimen |
| aprepitantAprepitant, three single doses of aprepitant will be administered orally. | Drug | Treatment Group 2: HTX-011 + Aprepitant |
Primary outcome
Mean Area Under the Curve (AUC) of the NRS-A (Windowed Worst Observation Carried Forward) Pain Intensity Scores
Time frame: 72 hours
Pain intensity scores are assessed 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 with the plantar surface of the ball of the surgically attended foot touching the floor (no weight-bearing).
4 secondary outcomes
Mean Total Postoperative Opioid Consumption (in Morphine Equivalents) Through 72 Hours
Time frame: 72 hours
Percentage of Subjects Receiving no Opioid Rescue
Time frame: 72 hours
Percentage of Subjects Receiving no Opioid Rescue
Time frame: Day 7 and Day 28
Mean Area Under the Curve (AUC) of the NRS-R (Windowed Worst Observation Carried Forward) Pain Intensity Scores
Time frame: 72 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HTX-011, Luer Lock applicator and Vial access device in people with Postoperative Pain, run by Heron Therapeutics at 1 site 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 23 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 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 26 Jun 2023). 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?
Mean Area Under the Curve (AUC) of the NRS-A (Windowed Worst Observation Carried Forward) Pain Intensity Scores (time frame: 72 hours). 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 2 Mar 2026.