Pediatric Postoperative Analgesia Herniorrhaphy Study

May 8, 2026 updated by: Heron Therapeutics

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Cleveland Medical Center
    • Texas
      • Plano, Texas, United States, 75093
        • Plano Surgical Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

3 years to 16 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cohort 1 Part A: HTX-011
Adolescents ≥12 to <17 years of age. A single dose of HTX-011 via instillation into the surgical site.
Device: Luer Lock Applicator
Applicator for instillation.
Drug: HTX-011
Single-dose instillation of approximately 0.17 mL/kg (total dose does not exceed 10.5 mL) of HTX-011.
Drug: HTX-011
Dose to be determined from Cohort 1.
Drug: HTX-011
Dose to be determined from Cohorts 1 and 2.
Drug: HTX-011
Dose to be determined from Cohort 1 Part A.
Active Comparator: Cohort 1 Part A: bupivacaine HCl
Adolescents ≥12 to <17 years of age. A single dose of bupivacaine HCl 0.25% (without epinephrine) via injection into the surgical site.
Drug: Bupivacaine HCl
Bupivacaine HCl 0.25% (without epinephrine) (total dose not to exceed 75 mg).
Experimental: Cohort 1 Part B: HTX-011
Adolescents ≥12 to <17 years of age. Dose to be determined from Cohort 1 Part A.
Device: Luer Lock Applicator
Applicator for instillation.
Drug: HTX-011
Single-dose instillation of approximately 0.17 mL/kg (total dose does not exceed 10.5 mL) of HTX-011.
Drug: HTX-011
Dose to be determined from Cohort 1.
Drug: HTX-011
Dose to be determined from Cohorts 1 and 2.
Drug: HTX-011
Dose to be determined from Cohort 1 Part A.
Active Comparator: Cohort 1 Part B: bupivacaine HCl
Adolescents ≥12 to <17 years of age. A single dose of bupivacaine HCl 0.25% (without epinephrine) via injection into the surgical site
Drug: Bupivacaine HCl
Bupivacaine HCl 0.25% (without epinephrine) (total dose not to exceed 75 mg).
Experimental: Cohort 2 Part A: HTX-011
Children ≥6 to <12 years of age. Dose to be determined from Cohort 1.
Device: Luer Lock Applicator
Applicator for instillation.
Drug: HTX-011
Single-dose instillation of approximately 0.17 mL/kg (total dose does not exceed 10.5 mL) of HTX-011.
Drug: HTX-011
Dose to be determined from Cohort 1.
Drug: HTX-011
Dose to be determined from Cohorts 1 and 2.
Drug: HTX-011
Dose to be determined from Cohort 1 Part A.
Active Comparator: Cohort 2 Part A: bupivacaine HCl
Children ≥6 to <12 years of age. A single dose of bupivacaine HCl 0.25% (without epinephrine) via injection into the surgical site
Drug: Bupivacaine HCl
Bupivacaine HCl 0.25% (without epinephrine) (total dose not to exceed 75 mg).
Experimental: Cohort 2 Part B: HTX-011
Children ≥6 to <12 years of age. Dose to be determined from Cohort 1.
Device: Luer Lock Applicator
Applicator for instillation.
Drug: HTX-011
Single-dose instillation of approximately 0.17 mL/kg (total dose does not exceed 10.5 mL) of HTX-011.
Drug: HTX-011
Dose to be determined from Cohort 1.
Drug: HTX-011
Dose to be determined from Cohorts 1 and 2.
Drug: HTX-011
Dose to be determined from Cohort 1 Part A.
Active Comparator: Cohort 2 Part B: bupivacaine HCl
Children ≥6 to <12 years of age. A single dose of bupivacaine HCl 0.25% (without epinephrine) via injection into the surgical site
Drug: Bupivacaine HCl
Bupivacaine HCl 0.25% (without epinephrine) (total dose not to exceed 75 mg).
Experimental: Cohort 3: HTX-011
Children ≥3 to <6 years of age. Dose to be determined from Cohorts 1 and 2.
Device: Luer Lock Applicator
Applicator for instillation.
Drug: HTX-011
Single-dose instillation of approximately 0.17 mL/kg (total dose does not exceed 10.5 mL) of HTX-011.
Drug: HTX-011
Dose to be determined from Cohort 1.
Drug: HTX-011
Dose to be determined from Cohorts 1 and 2.
Drug: HTX-011
Dose to be determined from Cohort 1 Part A.
Active Comparator: Cohort 3: bupivacaine HCl
Children ≥3 to <6 years of age. A single dose of bupivacaine HCl 0.25% (without epinephrine) via injection into the surgical site
Drug: Bupivacaine HCl
Bupivacaine HCl 0.25% (without epinephrine) (total dose not to exceed 75 mg).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Maximum concentration (Cmax)
Time Frame: 72 hours
72 hours
Time of occurrence of maximum concentration (Tmax)
Time Frame: 72 hours
72 hours
Area under the concentration-time curve (AUC) from Time 0 extrapolated to infinity (AUCinf)
Time Frame: 72 hours
72 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Proportion of subjects who do not receive an opioid prescription at discharge.
Time Frame: 72 hours
72 hours
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
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
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
72 hours
Total postoperative opioid consumption (in IV morphine milligram equivalents)
Time Frame: 72 hours
72 hours
Proportion of subjects who are opioid-free
Time Frame: 72 hours
72 hours
AUC of the Numeric Rating Scale pain intensity scores at rest (NRS-R)
Time Frame: 72 hours
72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Heron Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 17, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 19, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HTX-011-216

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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