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Pediatric Postoperative Analgesia Herniorrhaphy Study

NCT03922048 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2026-05-12

No results posted yet for this study

Summary

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

Conditions

  • Analgesia

Interventions

DRUG

HTX-011

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

DRUG

Bupivacaine HCl

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

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.

DEVICE

Luer Lock Applicator

Applicator for instillation.

Sponsors & Collaborators

  • Heron Therapeutics

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
3 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-31
Primary Completion
2025-11-30
Completion
2025-12-31
FDA Drug
Yes
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03922048 on ClinicalTrials.gov