AnalgesiaPhase 2NCT03922048
Pediatric Postoperative Analgesia Herniorrhaphy Study
A Phase 2 study testing HTX-011, Bupivacaine HCl and Luer Lock Applicator in people with Analgesia, run by Heron Therapeutics.
Trial summary
This is a Phase 2 study in pediatric subjects undergoing inguinal herniorrhaphy. Read more about this study
- Who is it for?
- Ages 3 to 16 years
- Conditions the study is for
- Analgesia
- What is being tested?
- HTX-011, Bupivacaine HCl and Luer Lock Applicator
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2023to Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 3 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Is scheduled to undergo a unilateral open inguinal herniorrhaphy with or without 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.
Who cannot join
- 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 planned concurrent surgical procedure (eg, bilateral herniorrhaphy).
- Has a contraindication or a known or suspected history of hypersensitivity or clinically significant idiosyncratic reaction to required study medications.
- Has taken meloxicam within least 10 days 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.
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- 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 a body mass index (BMI) >35 kg/m2.
- In addition to the preceding exclusion criteria 1 through 14, subjects to be enrolled in Cohort 1 Part B, Cohort 2 Part B, or Cohort 3 who meet any of the following criteria prior to randomization will be excluded from the study:
- Has had a prior ipsilateral inguinal 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 known or suspected daily use of opioids for 7 or more consecutive days within the previous 6 months.
- Has taken long-acting opioids within 3 days prior to the scheduled surgery.
- Has taken any opioids within 48 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 undergone 3 or more surgeries within 12 months.
About this study
Official title: A Phase 2, 2-Part, Open-Label, Dose-Finding and Double-Blind Study to Assess the Pharmacokinetics, Pharmacodynamics, and Safety of HTX-011 for Postoperative Analgesia in Adolescents and Children (≥3 to <17 Years of Age) Undergoing Unilateral Open Inguinal Herniorrhaphy
This is a Phase 2 study in pediatric subjects undergoing inguinal herniorrhaphy.
- Conditions
- Analgesia
- Being tested
- HTX-011, Bupivacaine HCl, Luer Lock Applicator
- Keywords
- inguinal hernia, postoperative pain, herniorrhaphy, pediatric, local anesthetic
- Medical subject headings
- Agnosia, Hernia, Inguinal, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HTX-011Drug
Single-dose instillation of approximately 0.17 mL/kg (total dose does not exceed 10.5 mL) of HTX-011.
Bupivacaine HClDrug
Bupivacaine HCl 0.25% (without epinephrine) (total dose not to exceed 75 mg).
HTX-011Drug
Dose to be determined from Cohort 1.
HTX-011Drug
Dose to be determined from Cohorts 1 and 2.
HTX-011Drug
Dose to be determined from Cohort 1 Part A.
Luer Lock ApplicatorDevice
Applicator for instillation.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 Part A: HTX-011 | Experimental | Adolescents ≥12 to <17 years of age. A single dose of HTX-011 via instillation into the surgical site. Receives: Drug: HTX-011; Device: Luer Lock Applicator |
| Cohort 1 Part A: bupivacaine HCl | Active comparator | Adolescents ≥12 to <17 years of age. A single dose of bupivacaine HCl 0.25% (without epinephrine) via injection into the surgical site. Receives: Drug: Bupivacaine HCl |
| Cohort 1 Part B: HTX-011 | Experimental | Adolescents ≥12 to <17 years of age. Dose to be determined from Cohort 1 Part A. Receives: Drug: HTX-011; Device: Luer Lock Applicator |
| Cohort 1 Part B: bupivacaine HCl | Active comparator | Adolescents ≥12 to <17 years of age. A single dose of bupivacaine HCl 0.25% (without epinephrine) via injection into the surgical site Receives: Drug: Bupivacaine HCl |
| Cohort 2 Part A: HTX-011 | Experimental | Children ≥6 to <12 years of age. Dose to be determined from Cohort 1. Receives: Drug: HTX-011; Device: Luer Lock Applicator |
| Cohort 2 Part A: bupivacaine HCl | Active comparator | Children ≥6 to <12 years of age. A single dose of bupivacaine HCl 0.25% (without epinephrine) via injection into the surgical site Receives: Drug: Bupivacaine HCl |
| Cohort 2 Part B: HTX-011 | Experimental | Children ≥6 to <12 years of age. Dose to be determined from Cohort 1. Receives: Drug: HTX-011; Device: Luer Lock Applicator |
| Cohort 2 Part B: bupivacaine HCl | Active comparator | Children ≥6 to <12 years of age. A single dose of bupivacaine HCl 0.25% (without epinephrine) via injection into the surgical site Receives: Drug: Bupivacaine HCl |
| Cohort 3: HTX-011 | Experimental | Children ≥3 to <6 years of age. Dose to be determined from Cohorts 1 and 2. Receives: Drug: HTX-011; Device: Luer Lock Applicator |
| Cohort 3: bupivacaine HCl | Active comparator | Children ≥3 to <6 years of age. A single dose of bupivacaine HCl 0.25% (without epinephrine) via injection into the surgical site Receives: Drug: Bupivacaine HCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration-time curve (AUC) from Time 0 extrapolated to infinity (AUCinf)
Measured: 72 hours
Maximum concentration (Cmax)
Measured: 72 hours
Time of occurrence of maximum concentration (Tmax)
Measured: 72 hours
Secondary outcomes (7)
Adolescents ≥12 to <17 years of age (Cohort 1): area under the curve (AUC) of the Numeric Rating Scale of pain intensity scores with activity (NRS-A)
Measured: 72 hours
Children ≥6 to <12 years of age (Cohort 2): AUC of the Faces-Pain-Scale (FPS)-Revised pain intensity scores
Measured: 72 hours
Children ≥3 to <6 years of age (Cohort 3): AUC of the Faces, Legs, Activity, Cry, Consolability (FLACC) scale pain intensity scores
Measured: 72 hours
Total postoperative opioid consumption (in IV morphine milligram equivalents)
Measured: 72 hours
Proportion of subjects who are opioid-free
Measured: 72 hours
AUC of the Numeric Rating Scale pain intensity scores at rest (NRS-R)
Measured: 72 hours
Proportion of subjects who do not receive an opioid prescription at discharge.
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 posted19 Apr 2019
- Study startJul 2023 (estimated)
- Primary completionNov 2025 (estimated)
- Study completionDec 2025 (estimated)
Why it stopped: Withdrawn due to lack of enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 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
- NCT03922048
- Sponsor's protocol ID
- HTX-011-216
- Status last verified
- May 2026
- First submitted
- 17 Apr 2019
- Last updated
- 12 May 2026
- Results posted
- No
- 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 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, 2-Part, Open-Label, Dose-Finding and Double-Blind Study to Assess the Pharmacokinetics, Pharmacodynamics, and Safety of HTX-011 for Postoperative Analgesia in Adolescents and Children (≥3 to <17 Years of Age) Undergoing Unilateral Open Inguinal Herniorrhaphy
- ClinicalTrials.gov ID
- NCT03922048
- Acronym / sponsor ID
- HTX-011-216
- Conditions
- Analgesia
- Keywords
- inguinal hernia, postoperative pain, herniorrhaphy, pediatric, local anesthetic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Withdrawn due to lack of enrollment.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Heron TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Jul 2023 (estimated)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 19 Apr 2019 (actual)
- Results
- Not posted in the source record
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 study in pediatric subjects undergoing inguinal herniorrhaphy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 Part A: HTX-011 | Experimental | Drug: HTX-011, Device: Luer Lock ApplicatorAdolescents ≥12 to <17 years of age. A single dose of HTX-011 via instillation into the surgical site. |
| Cohort 1 Part A: bupivacaine HCl | Active comparator | Drug: Bupivacaine HClAdolescents ≥12 to <17 years of age. A single dose of bupivacaine HCl 0.25% (without epinephrine) via injection into the surgical site. |
| Cohort 1 Part B: HTX-011 | Experimental | Drug: HTX-011, Device: Luer Lock ApplicatorAdolescents ≥12 to <17 years of age. Dose to be determined from Cohort 1 Part A. |
| Cohort 1 Part B: bupivacaine HCl | Active comparator | Drug: Bupivacaine HClAdolescents ≥12 to <17 years of age. A single dose of bupivacaine HCl 0.25% (without epinephrine) via injection into the surgical site |
| Cohort 2 Part A: HTX-011 | Experimental | Drug: HTX-011, Device: Luer Lock ApplicatorChildren ≥6 to <12 years of age. Dose to be determined from Cohort 1. |
| Cohort 2 Part A: bupivacaine HCl | Active comparator | Drug: Bupivacaine HClChildren ≥6 to <12 years of age. A single dose of bupivacaine HCl 0.25% (without epinephrine) via injection into the surgical site |
| Cohort 2 Part B: HTX-011 | Experimental | Drug: HTX-011, Device: Luer Lock ApplicatorChildren ≥6 to <12 years of age. Dose to be determined from Cohort 1. |
| Cohort 2 Part B: bupivacaine HCl | Active comparator | Drug: Bupivacaine HClChildren ≥6 to <12 years of age. A single dose of bupivacaine HCl 0.25% (without epinephrine) via injection into the surgical site |
| Cohort 3: HTX-011 | Experimental | Drug: HTX-011, Device: Luer Lock ApplicatorChildren ≥3 to <6 years of age. Dose to be determined from Cohorts 1 and 2. |
| Cohort 3: bupivacaine HCl | Active comparator | Drug: Bupivacaine HClChildren ≥3 to <6 years of age. A single dose of bupivacaine HCl 0.25% (without epinephrine) via injection into the surgical site |
Who may qualify
- Ages
- 3 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Is scheduled to undergo a unilateral open inguinal herniorrhaphy with or without 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.
Key exclusion criteria (19 listed)
- 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 planned concurrent surgical procedure (eg, bilateral herniorrhaphy).
- Has a contraindication or a known or suspected history of hypersensitivity or clinically significant idiosyncratic reaction to required study medications.
- Has taken meloxicam within least 10 days prior to the scheduled surgery.
- Has been administered bupivacaine within 5 days 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-011Single-dose instillation of approximately 0.17 mL/kg (total dose does not exceed 10.5 mL) of HTX-011. | Drug | Cohort 1 Part A: HTX-011 |
| Bupivacaine HClBupivacaine HCl 0.25% (without epinephrine) (total dose not to exceed 75 mg). | Drug | Cohort 1 Part A: bupivacaine HCl, Cohort 1 Part B: bupivacaine HCl, Cohort 2 Part A: bupivacaine HCl, Cohort 2 Part B: bupivacaine HCl, Cohort 3: bupivacaine HCl |
| HTX-011Dose to be determined from Cohort 1. | Drug | Cohort 2 Part A: HTX-011, Cohort 2 Part B: HTX-011 |
| HTX-011Dose to be determined from Cohorts 1 and 2. | Drug | Cohort 3: HTX-011 |
| HTX-011Dose to be determined from Cohort 1 Part A. | Drug | Cohort 1 Part B: HTX-011 |
| Luer Lock ApplicatorApplicator for instillation. | Device | Cohort 1 Part A: HTX-011, Cohort 1 Part B: HTX-011, Cohort 2 Part A: HTX-011, Cohort 2 Part B: HTX-011, Cohort 3: HTX-011 |
Primary outcome
Area under the concentration-time curve (AUC) from Time 0 extrapolated to infinity (AUCinf)
Time frame: 72 hours
Maximum concentration (Cmax)
Time frame: 72 hours
Time of occurrence of maximum concentration (Tmax)
Time frame: 72 hours
7 secondary outcomes
Adolescents ≥12 to <17 years of age (Cohort 1): area under the curve (AUC) of the Numeric Rating Scale of pain intensity scores with activity (NRS-A)
Time frame: 72 hours
Children ≥6 to <12 years of age (Cohort 2): AUC of the Faces-Pain-Scale (FPS)-Revised pain intensity scores
Time frame: 72 hours
Children ≥3 to <6 years of age (Cohort 3): AUC of the Faces, Legs, Activity, Cry, Consolability (FLACC) scale pain intensity scores
Time frame: 72 hours
Total postoperative opioid consumption (in IV morphine milligram equivalents)
Time frame: 72 hours
Proportion of subjects who are opioid-free
Time frame: 72 hours
AUC of the Numeric Rating Scale pain intensity scores at rest (NRS-R)
Time frame: 72 hours
Proportion of subjects who do not receive an opioid prescription at discharge.
Time frame: 72 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HTX-011, Bupivacaine HCl and Luer Lock Applicator in people with Analgesia, run by Heron Therapeutics.
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 19 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: withdrawn, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Area under the concentration-time curve (AUC) from Time 0 extrapolated to infinity (AUCinf) (time frame: 72 hours). The study lists 3 primary outcomes in all. 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 12 May 2026; AzTrials last refreshed its copy on 27 Oct 2026.