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Liposomal Bupivacaine vs Standard Penile Block for Hypospadias Repair

NCT04479371 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2021-08-16

No results posted yet for this study

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 will use an envelope system for randomizing 1:1 to either group.

Approach to surgery will be determined by the location of the urethral meatus and degree of chordee along with the amount of skin available and provider preference. Patients who have an ASA classification of 3 or greater, renal or hepatic dysfunction, less than 6 months of age, or refuse the risk of using liposomal bupivacaine during the procedure will be excluded.

The goal is to compare the pain scores of standard bupivacaine penile blocks versus liposomal bupivacaine penile blocks for patients undergoing hypospadias surgery. This is also an opportunity to use liposomal bupivacaine in children as a regional local block for penile surgery. Patients will be enrolled at Children's Medical Center from July 1st, 2019 until 100 total patients are accrued, as specified in our sample size calculation. It is estimated that the trial will be completed in five years with hopes of potentially reaching 100 patients within two years.

Conditions

  • Hypospadias

Interventions

DRUG

Liposomal bupivacaine

Injecting liposomal bupivacaine for a penile block for analgesia for hypospadias repair

DRUG

Bupivacaine

Standard bupivacaine

Sponsors & Collaborators

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • Craig Peters, MD · UT Southwestern

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
24 Months
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-07-31
Primary Completion
2022-07-30
Completion
2023-07-30

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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 NCT04479371 on ClinicalTrials.gov