Status:

WITHDRAWN

Liposomal Bupivacaine vs Standard Penile Block for Hypospadias Repair

Lead Sponsor:

University of Texas Southwestern Medical Center

Conditions:

Hypospadias

Eligibility:

MALE

6-24 years

Phase:

PHASE1

Brief Summary

The investigator proposes a prospective randomized study of males with hypospadias to either bupivacaine penile block or liposomal bupivacaine block for hypospadias repair, Figure 3. The investigator ...

Detailed Description

Male patients who are greater than 6 months of age will be enrolled in the study prior to elective outpatient hypospadias repair with ASA class 1-2. For a male who meets the inclusion criteria, after ...

Eligibility Criteria

Inclusion

  • Males aged 6 months to 24 months of all races and ethnicities that have hypospadias requiring surgical intervention and post-operative urethral catheterization.

Exclusion

  • Males who are not age 6 mo. to 24 months, those who do not have a diagnosis of hypospadias, those who have an ASA class of 3 or greater or known liver or renal impairment, or who have an allergy to local anesthetics such as lidocaine, bupivacaine, etc.

Key Trial Info

Start Date :

July 1 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 30 2023

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT04479371

Start Date

July 1 2021

End Date

July 30 2023

Last Update

August 16 2021

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