Does Caudal Block Increase the Incidence of Urethrocutaneous Fistula Formation Following Hypospadias Repair in Infants?



Status:Recruiting
Conditions:Hospital
Therapuetic Areas:Other
Healthy:No
Age Range:Any - 2
Updated:10/13/2018
Start Date:May 24, 2017
End Date:July 31, 2020
Contact:David M Polaner, MD
Email:david.polaner@ucdenver.edu
Phone:720-777-6226

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Does Caudal Block Increase the Incidence of Urethrocutaneous Fistula Formation Following Hypospadias Repair in Infants? A Multi-center Prospective Randomized Trial.

This is a prospective randomized multi-center non-inferiority trial conducted through the
Pediatric Regional Anesthesia Network study sites to determine if caudal block increases the
incidence of urethrocutaneous fistula following distal or mid shaft hypospadias repair
compared with penile nerve block.

Small retrospective series are in conflict about whether there is an association between
caudal block and urethrocutaneous fistulas after hypospadias repair. The most common
alternative to caudal blockade is a penile nerve block. The investigators will test the
following hypothesis:

There is no difference in the incidence of urethrocutaneous fistula formation following
single stage hypospadias repair with caudal anesthesia compared with penile nerve block.

The investigators will use a prospective randomized controlled design where subjects will
receive either a caudal block or a penile nerve block to provide postoperative analgesia.
Meatal anatomy will be graded by the urologist in the anesthetized child according to the
HOPE (Hypospadias Objective Penile Evaluation) score, a validated scoring system. Both the
total score and the individual component scores will be recorded. The operating urologist
will determine the presence or absence of a fistula at the postoperative visit about 12 weeks
after surgery, with subsequent follow up at 6 months and again at 12 months.

Inclusion Criteria:

- infants/ children with midshaft or distal hypospadias undergoing primary single stage
repair in one of the Pediatric Regional Anesthesia Network participating centers.

Exclusion Criteria:

- prior hypospadias surgery,

- proximal or penoscrotal hypospadias,

- abnormal caudal anatomy or spinal dysraphism,

- cyanotic congenital heart disease,

- infection or rash at the block injection site.
We found this trial at
1
site
13123 E 16th Ave
Aurora, Colorado 80045
(720) 777-1234
Principal Investigator: David Polaner, MD
Children's Hospital Colorado At Children's Hospital Colorado, we see more, treat more and heal more...
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