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Opioid Reduction Initiative During Outpatient Pediatric Urologic Procedures Using Exparel

NCT04826484 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2023-12-26

Study results available
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Summary

This study aims to evaluate the utility of long-acting liposomal bupivacaine (Exparel®) in improving pain scores and reducing narcotic pain requirements in pediatric patients following minor urologic procedures.

Conditions

  • Urologic Diseases
  • Hypospadias
  • Undescended Testes
  • Chordee
  • Hydrocele
  • Orchiectomy

Interventions

DRUG

Exparel 133 miligrams per 10 milliliter injection

Local wound infiltration with Exparel 133 miligrams per 10 milliliter injection

DRUG

Bupivacaine Hydrochloride

Local wound infiltration with 0.25% bupivacaine.

Sponsors & Collaborators

Principal Investigators

  • Heather N DiCarlo, MD · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-01
Primary Completion
2023-04-26
Completion
2023-04-26
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT04826484 on ClinicalTrials.gov