Pediatric Postoperative Analgesia Herniorrhaphy Study

NCT03922048 | Withdrawn Phase 2 FDA Drug FDA Device

• 1 other identifier: HTX-011-216
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a Phase 2 study in pediatric subjects undergoing inguinal herniorrhaphy.

Conditions

Analgesia

Keywords

inguinal hernia; postoperative pain; herniorrhaphy; pediatric; local anesthetic

Outcome Measures

Primary Outcomes (3)

• Area under the concentration-time curve (AUC) from Time 0 extrapolated to infinity (AUCinf)

  72 hours

• Maximum concentration (Cmax)

  72 hours

• Time of occurrence of maximum concentration (Tmax)

  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)

  72 hours

• Children ≥6 to <12 years of age (Cohort 2): AUC of the Faces-Pain-Scale (FPS)-Revised pain intensity scores

  72 hours

• Children ≥3 to <6 years of age (Cohort 3): AUC of the Faces, Legs, Activity, Cry, Consolability (FLACC) scale pain intensity scores

  72 hours

• Total postoperative opioid consumption (in IV morphine milligram equivalents)

  72 hours

• Proportion of subjects who are opioid-free

  72 hours

Study Arms (10)

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.

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.

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.

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

Drug: Bupivacaine HCl

Cohort 2 Part A: HTX-011

EXPERIMENTAL

Children ≥6 to \<12 years of age. Dose to be determined from Cohort 1.

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

Drug: Bupivacaine HCl

Cohort 2 Part B: HTX-011

EXPERIMENTAL

Children ≥6 to \<12 years of age. Dose to be determined from Cohort 1.

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

Drug: Bupivacaine HCl

Cohort 3: HTX-011

EXPERIMENTAL

Children ≥3 to \<6 years of age. Dose to be determined from Cohorts 1 and 2.

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

Drug: Bupivacaine HCl

Interventions

HTX-011 DRUG

Single-dose instillation of approximately 0.17 mL/kg (total dose does not exceed 10.5 mL) of HTX-011.

Cohort 1 Part A: HTX-011

Bupivacaine HCl DRUG

Bupivacaine HCl 0.25% (without epinephrine) (total dose not to exceed 75 mg).

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

Luer Lock Applicator DEVICE

Applicator for instillation.

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

Eligibility Criteria

• Age: 3 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Heron Therapeutics: lead

MeSH Terms

Conditions

Agnosia; Hernia, Inguinal; Pain, Postoperative

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Postoperative Complications; Pathologic Processes; Pain

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2019
• First Posted: April 19, 2019
• Study Start: July 1, 2023
• Primary Completion: November 1, 2025
• Study Completion: December 1, 2025
• Last Updated: June 5, 2023

Record last verified: 2023-06