Recruiting

Caudal vs. Local AnesthesiaCaudal vs Local Anesthesia in Hypospadias

Sponsor:

McMaster University

Code:

NCT02512887

Conditions

Hypospadias

Eligibility Criteria

Sex: Male

Age: 0 - 4

Healthy Volunteers: Not accepted

Interventions

Caudal Block Anesthesia

Dorsal Penile Block Anesthesia

Study Details

Brief summary:

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.

Conditions

Hypospadias

Study ID

NCT02512887

Start date

Jul, 2016

Status verified date

Mar, 2023

Completion date

Jan, 2024

Anticipated

Primary completion date

Jan, 2024

Anticipated

Eligibility Criteria

Sex: Male

Age: 0 - 4

Healthy Volunteers: Not accepted

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:

Patients who have undergone previous hypospadias surgery
Patients who have contraindications to either caudal or dorsal penile block
Inability of parent/guardian to understand English/French
Deviation to pre-established anesthesia protocol

Study Design

Enrollment

224 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Caudal Block Anesthesia

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.

active comparator: Dorsal Penile Block Anesthesia

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.

Interventions

Caudal Block Anesthesia

Dorsal Penile Block Anesthesia

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.

Primary outcome measure

Post-operative Complication Rate [ Time Frame: Follow-up to assess the complications, specifically urethrocutaneous fistula (UCF) and glans dehiscence within 12 months post-surgery. ]
Recruitment rate [ Time Frame: trial duration 1 year ]
Protocol violations or Adverse events [ Time Frame: trial duration 1 year ]

Central Contacts and Locations

Central contacts

Luis Braga, MD

905-521-2100 braga@mcmaster.ca

Melissa McGrath

905-521-2100 mcgram2@mcmaster.ca

Locations

McMaster Children's Hospital

Recruiting

Hamilton, Ontario, Canada, L8N 3Z5

Contacts

Luis Braga, MD

905-521-2100 braga@mcmaster.ca

More Information

Sponsor

McMaster University

Last update posted

Mar 15, 2023

Last verified

Mar, 2023

Keywords

Hypospadias
Caudal Block
Dorsal Penile Block
Anesthesia
Complications
Post-operative
Urethrocutaneous Fistula
Glans dehiscence

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McMaster University on 2023-03-15.