Trial | NCT02861950  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Active, not recruiting

  • Study Participants

    490
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.
Study Started
May 24
2017
Primary Completion
Dec 31
2023
Anticipated
Study Completion
Dec 31
2023
Anticipated
Last Update
Jan 25
2023

Drug Caudal block with ropivacaine

Patients in this arm will receive a caudal block with ropivacaine

Drug penile nerve block with bupivacaine

Patients in this arm will receive a penile block with bupivacaine

Caudal block Active Comparator

Patients will receive a caudal block with 0.75-1ml/kg of 0.2% ropivacaine.

Penile Nerve Block Active Comparator

Patients will receive a dorsal penile nerve block with up to 0.75ml/kg of 0.25% bupivacaine.

Criteria 

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.
No Results Posted