- Design
- Multicentre randomised non-inferiority trial, terminated early
- Population
- 210 children ≤2 years having primary distal or midshaft hypospadias repair (161 analysed)
- Primary outcome
- Urethrocutaneous fistula within 3 months
- Effect
- 8.9% vs 7.3%; RR 0.98 (95% CI 0.35 to 2.76)
A randomised non-inferiority trial across 16 Pediatric Regional Anesthesia Network centres assigned children aged 2 or under having single-stage distal or midshaft hypospadias repair to caudal or penile block with general anaesthesia. The trial stopped early; 161 of 210 completed three-month follow-up.
Fistula occurred in 8.9% after caudal and 7.3% after penile block (RR 0.98, 95% CI 0.35 to 2.76). A proximal meatus was the stronger risk factor (RR 2.8). Caudal block reduced intraoperative opioid (33% vs 56%) and rescue opioid (4.9% vs 15.7%), with lower recovery pain scores.
The trial does not settle whether caudal block raises fistula risk; its interval is wide. But it gives no support to abandoning caudal on those grounds, and caudal block delivered better analgesia.
- Either block is reasonable for distal or midshaft repair in young children.
- Choose on analgesia, local skill and surgeon discussion, not on fistula risk alone.
- Record meatal position — it predicts fistula more than block type.
- Plan rescue analgesia for penile block patients.
Why it matters
Surgeons' concerns about caudal block and fistula have been driving block choice without randomised evidence.
Don't overread it
Stopped early with nearly a quarter lost to follow-up; a clinically important difference cannot be excluded.
The statistics, in plain English
A risk ratio of 0.98 with an interval from 0.35 to 2.76 means the data fit anything from a large reduction to nearly tripling fistula risk. The trial could not answer the question it was designed for.
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