Does caudal block increase the incidence of urethrocutaneous fistula formation following hypospadias repair in infants? A multi-center prospective randomized trial
Study ID: STU 072016-087
Caudal blockade is the most commonly performed regional anesthetic in children and has been shown to have a high degree of safety. Large prospective studies in infants and young children have shown that serious anesthetic complications such as local anesthetic toxicity, nerve injury, or infection are very rare, occurring in less than 0.003% of cases. Several recent studies, however, have suggested that in children who undergo repair of hypospadias (a common birth defect where the urethra- the tube that carries urine from the bladder- exits the penis in the middle of the shaft instead of at its tip), a possible relationship exists between caudal blockade and the development of postoperative urethrocutaneous fistula formation. a fistula is a breakdown of the repair where a communication develops between the urethra and the skin. other retrospective studies, however, have found no relationship. our research question is whether the administration of a caudal block increases the incidence of urethrocutaneous fistula formation in infants following hypospadias repair. We will study this by randomizing infants who need this operation to receive either a caudal block or a penile nerve block, and following them to see if there is a difference in the number who form fistulas.
All infants 5 months to 2 years of age with midshaft or distal hypospadias undergoing single stage repair in one of the PRAN centers
Specific aim: To determine if administration of a caudal block increases the incidence of fistula formation following single stage hypospadias repair in infants 5 months to 2 years of age. 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. We 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. We will use a prospective randomized controlled design where subjects will receive either a caudal block or a penile nerve block to provide postoperative analgesia. 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.