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Clinical trial

Caudal vs Local Anesthesia in Hypospadias: The CLASH Study

ID
Name
CLASH
Description
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.
Trial arms
Trial start
2016-07-01
Estimated PCD
2024-01-01
Trial end
2024-01-01
Status
Recruiting
Treatment
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.
Arms:
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.
Arms:
Dorsal Penile Block Anesthesia
Other names:
Local Anesthesia
Size
224
Primary endpoint
Post-operative Complication Rate
Follow-up to assess the complications, specifically urethrocutaneous fistula (UCF) and glans dehiscence within 12 months post-surgery.
Recruitment rate
trial duration 1 year
Protocol violations or Adverse events
trial duration 1 year
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 224, 'type': 'ESTIMATED'}}
Updated at
2023-03-15

1 organization

2 products

1 indication

Organization
McMaster University
Product
Caudal Block
Indication
Hypospadias
Product
Dorsal Penile Block Anesthesia