- Design
- Multicentre randomised non-inferiority trial, stopped early
- Population
- 161 children aged 2 or under with single-stage distal or midshaft hypospadias repair
- Primary outcome
- Urethrocutaneous fistula within 3 months
- Effect
- 8.9% caudal vs 7.3% penile; RR 0.98 (95% CI 0.35–2.76)
Retrospective studies have linked caudal blocks to more urethrocutaneous fistula after hypospadias repair, without always accounting for severity. A trial across 16 paediatric regional anaesthesia network centres randomised children up to two years old having single-stage distal or midshaft repair to caudal or penile block under general anaesthesia.
Of 210 enrolled, 161 completed three months. Fistula occurred in 8.9% after caudal and 7.3% after penile block (RR 0.98, 95% CI 0.35–2.76). A proximal meatus nearly tripled fistula risk. Caudal blocks needed less intraoperative opioid (33% vs 56%) and less rescue opioid, with lower recovery-room pain scores.
The trial stopped early with losses to follow-up, so its interval is wide. It gives no support to avoiding caudal block on fistula grounds, and the analgesic advantage is clear.
- Do not avoid caudal block for hypospadias repair solely over fistula concern.
- Expect less opioid use with caudal than penile block.
- Recognise that meatal position, not block type, was the main fistula risk factor.
- Discuss block choice with the surgical team in advance.
Why it matters
It weakens a retrospective concern that has steered some teams away from caudal blocks.
Don't overread it
The trial stopped early, and its interval cannot exclude a clinically important difference.
The statistics, in plain English
A relative risk interval from 0.35 to 2.76 is very wide: the data fit a large reduction or a near-tripling of fistula. 'No significant difference' here reflects uncertainty, not proven equivalence.
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