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

University of Colorado Denver (CU Denver)

Status and phase: Completed; Phase 4

Conditions: Urethrocutaneous Fistula; Hypospadias

Treatments: Drug: penile nerve block with bupivacaine; Drug: Caudal block with ropivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT02861950

15-2343

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 165 patients

Sex: Male

Ages: 4 months to 2 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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165 participants in 2 patient groups

Caudal block

Active Comparator group

Description:

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

Treatment:

Drug: Caudal block with ropivacaine

Penile Nerve Block

Active Comparator group

Description:

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

Treatment:

Drug: penile nerve block with bupivacaine