NCT03922048 - Pediatric Postoperative Analgesia Herniorrhaphy Study | Biotech Hunter

Timeline

Start Date

July 31, 2023

Primary Completion Date

November 30, 2025

Study Completion Date

December 31, 2025

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.