Caudal vs Local Anesthesia for Hypospadias
(CLASH Trial)

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen byLuis Braga, MD

Age: < 18

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: McMaster University

No Placebo Group

Trial Summary

What is the purpose of this trial?

Hypospadias is one of the most common congenital malformations of the genitalia in boys, and is typically managed by surgical intervention. During pediatric urological surgery, caudal anesthesia is one of the most common regional anesthetic techniques used. Also known as caudal block, it has been shown to be a safe and effective anesthetic technique in children with a low incidence of anesthesia-related complications.While the reported incidence of complications directly associated with caudal block is low, there is scarce and inconclusive evidence on the impact of caudal anesthesia on the incidence of surgical complications. As a result, the objective of this superiority, randomized controlled trial is to assess whether the use of caudal anesthesia, when compared to dorsal penile block, is associated with a higher rate of urethrocutaneous fistulas and glans dehiscence post hypospadias repair.

Research Team

Luis Braga, MD

Principal Investigator

McMaster University

Eligibility Criteria

This trial is for boys aged 6-48 months needing hypospadias repair by specialized pediatric urologists. It's not for those who've had previous surgery for hypospadias, can't follow the anesthesia plan, or whose guardians don't understand English/French.

Inclusion Criteria

Males 6-48 months of age at presentation to Pediatric Urology clinics

Patient who requires hypospadias repair by fellowship-trained Pediatric Urologists.

Exclusion Criteria

Inability of parent/guardian to understand English/French

Deviation to pre-established anesthesia protocol

You had a surgery in the past for hypospadias.

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Treatment Details

Interventions

Caudal Block Anesthesia (Local Anesthesia)
Dorsal Penile Block Anesthesia (Local Anesthesia)

Trial OverviewThe study compares two types of anesthesia in young boys undergoing surgery for hypospadias: caudal block and dorsal penile block. The goal is to see if one leads to fewer surgical complications like fistulas or glans issues post-surgery.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Caudal Block AnesthesiaExperimental Treatment1 Intervention

Anesthesia will be delivered via inhalation induction with air/nitrous oxide and sevoflurane, and injection of 0.25% bupivacaine 1mL/kg without epinephrine into the caudal canal, which is the sacral portion of the spinal canal.

Group II: Dorsal Penile Block AnesthesiaActive Control1 Intervention

Anesthesia will be delivered via inhalation induction with air/nitrous oxide and sevoflurane, and injection of 0.25% bupivacaine without epinephrine into the dorsal portion of the penis.