Opioid Reduction Initiative During Outpatient Pediatric Urologic Procedures Using Exparel

Last updated: December 6, 2023
Sponsor: Johns Hopkins University
Overall Status: Terminated

Phase

3

Condition

Peyronie's Disease

Male Hormonal Deficiencies/abnormalities

Hypogonadism

Treatment

Exparel 133 miligrams per 10 milliliter injection

Bupivacaine Hydrochloride

Clinical Study ID

NCT04826484
IRB00284462
  • Ages > 6
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Pediatric patients 6 years and older undergoing minor pediatric urologic surgery
  • Patients who are otherwise eligible to receive routine care following minor urologicsurgery

Exclusion

Exclusion Criteria:

  • Contraindication to receiving local anesthetics (i.e. pre-existing cardiac, renal,hepatic dysfunction)
  • Pediatric patients younger than 6 years of age
  • Pediatric patients with a history of pain syndromes or are unable to tolerate opiatemedication
  • Unwilling to participate in 48 hours and 10-14 day follow-up phone calls

Study Design

Total Participants: 104
Treatment Group(s): 2
Primary Treatment: Exparel 133 miligrams per 10 milliliter injection
Phase: 3
Study Start date:
October 01, 2021
Estimated Completion Date:
April 26, 2023

Connect with a study center

  • Johns Hopkins Hospital

    Baltimore, Maryland 21287
    United States

    Site Not Available

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