Liposomal Bupivacaine vs Standard Penile Block for Hypospadias Repair
Status:
Withdrawn
Trial end date:
2023-07-30
Target enrollment:
Participant gender:
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.