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

Phase 4

Completed

• Conditions: Hypospadias; Urethrocutaneous Fistula
• Interventions: Drug: Caudal block with ropivacaine; Drug: penile nerve block with bupivacaine

• Registration Number: NCT02861950
• Lead Sponsor: University of Colorado, Denver

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2016-06-21
• Study First Submitted QC: 2016-08-09
• Study First Posted: 2016-08-10
• Study Start: 2017-05-24
• Primary Completion: 2023-09-20
• Study Completion: 2023-09-20
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-28
• Last Update Posted: 2024-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 165

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Caudal block	Caudal block with ropivacaine	Patients will receive a caudal block with 0.75-1ml/kg of 0.2% ropivacaine.
Penile Nerve Block	penile nerve block with bupivacaine	Patients will receive a dorsal penile nerve block with up to 0.75ml/kg of 0.25% bupivacaine.

Primary Outcome Measures

Name	Time	Method
Incidence of urethrocutaneous fistula	1 year	Presence of a urethrocutaneous fistula at postoperative visit up to 1 year after surgery.

Secondary Outcome Measures

Name	Time	Method
Degree of efficacy of caudal block	1 hour after arrival in Post Anesthesia Care Unit (PACU) post surgery	Blocks will be graded for efficacy using the following scale: Successful, Probably Successful, Probably Failed, or Failed.
Degree of pain	1 hour after arrival in PACU post surgery	Patients will have pain scores determined using the modified FLACC score (Face, Legs, Activity, Cry, Consolability) 1 hour after arrival in the PACU
Need for supplemental analgesics	1 hour after arrival in PACU post surgery	Administration of opioid in the first postoperative hour will be determined

Trial Locations

Locations (1)

Children's Hospital Colorado; 🇺🇸 Aurora, Colorado, United States