The effect of caudal epidural block on the surgical complications of hypospadias repair in children aged 6 to 35 months: A randomized controlled trial

Abstract

Caudal epidural block (CEB) in hypospadias surgery has the benefit of reducing post-operative pain and possibly intra-operative bleeding. Some studies, however, have suggested that this technique may increase the rate of post-operative complications. Considering the uncertainty about the effect of CEB on surgical complications of hypospadias repair, the current study was performed. The aim of this randomized clinical trial was to compare the complication rates between patients who receive CEB after hypospadias surgery and those who did not. This double-blind randomized controlled trial was conducted on boys aged 6-35 months, who underwent hypospadias repair surgery in a university hospital from March 2018 to March 2019. Sixty patients were randomly divided into two groups (group A: 31 and group B: 29). In group B, CEB was performed, using 0.5mg/kg of 0.125% bupivacaine (Marcaine). Postoperative complications including fistula, meatal stenosis, dehiscence, and occurrence of bleeding were assessed during six months after surgery. The patients were assessed for possible complications at 24h, one week, one, three and six months after surgery. No remarkable differences were observed between the patients in the two groups in terms of the frequency of dehiscence, fistula, and meatal stenosis (P>0.05). Moreover, the difference in complication rates between the patients with proximal and distal hypospadias did not reach statistical significance (P=0.549). Assessment of complications showed no significant difference between the two study groups in terms of dehiscence, fistula, and meatal stenosis (Clavien type III). In addition, complication rate was not significantly different according to severity of hypospadias between the two groups. Our study had limitations such as short follow up and small sample size, which resulted in insignificant difference in complication rate between proximal and distal hypospadias. These limitations request large studies with long term follow up. The current study showed that the use of caudal block anesthesia in comparison with general anesthesia did not increase surgical complications, which approved CEB protocol as a safe method in hypospadias repair.