drugset
drugset / Trial / NCT04479371

Liposomal Bupivacaine vs Standard Penile Block for Hypospadias Repair

NCT04479371 ↗

Phase 1 Withdrawn University of Texas Southwestern Medical Center
RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

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

Publications

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bupivacaine Other / unclassified 2 mg/kg Other
Comparator Bupivacaine Other / unclassified 2.5 mg/kg Other
Comparator Bupivacaine Other / unclassified 3 mg/kg Other
Comparator Bupivacaine Other / unclassified 4 mg/kg Other

Indications

hypospadias