Caudal vs Local Anesthesia in Hypospadias

NCT02512887 | Unknown DMC

• 1 other identifier: CLASH
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 4

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Post-operative Complication Rate

  UCF is defined as an abnormal communication between the reconstructed urethra and the skin located between the original meatus and the tip of the penis.Glans dehiscence is considered as a complete separation of the glans wings with or without a band of skin between them.

  Follow-up to assess the complications, specifically urethrocutaneous fistula (UCF) and glans dehiscence within 12 months post-surgery.

• Recruitment rate

  Percentage of eligible participants enrolled, Randomization rate (percentage of enrolled participants randomized)

  trial duration 1 year

• Protocol violations or Adverse events

  Frequency of protocol violations or adverse events related to the study intervention.

  trial duration 1 year

Secondary Outcomes (5)

• Operating Room (OR) time

  Record duration of operative time (takes on average 30-45 minutes)

• Complications directly related to caudal block

  Complications will be measured at a clinic visit 48 hours after surgery.

• Complications directly related to dorsal penile block

  Complications will be measured at a clinic visit 48 hours after surgery.

• Post-operative Pain

  Measure at patient admission and discharge at 30 minute intervals.

• Post-operative Pain

  Measure at patient admission and discharge at 30 minute intervals.

Study Arms (2)

Caudal Block Anesthesia

EXPERIMENTAL

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.

Drug: Caudal Block Anesthesia

Dorsal Penile Block Anesthesia

ACTIVE COMPARATOR

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.

Drug: Dorsal Penile Block Anesthesia

Interventions

Caudal Block Anesthesia DRUG

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.

Caudal Block Anesthesia

Dorsal Penile Block Anesthesia DRUG

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.

Also known as: Local Anesthesia

Dorsal Penile Block Anesthesia

Eligibility Criteria

• Age: 6 Months - 48 Months
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Males 6-48 months of age at presentation to Pediatric Urology clinics
• Patient who requires hypospadias repair by fellowship-trained Pediatric Urologists.

You may not qualify if:

• 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

Sponsors & Collaborators

• McMaster University: lead
• Canadian Urological Association: collaborator

Study Sites (4)

McMaster Children's Hospital

Hamilton, Ontario, L8N 3Z5, Canada

RECRUITING

Children's Hospital, London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

NOT YET RECRUITING

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

NOT YET RECRUITING

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

NOT YET RECRUITING

MeSH Terms

Conditions

Hypospadias

Interventions

Anesthesia, Local

Condition Hierarchy (Ancestors)

Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Penile Diseases; Genital Diseases, Male; Genital Diseases; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• Luis Braga, MD

  McMaster University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luis Braga, MD

CONTACT

905-521-2100; braga@mcmaster.ca

Melissa McGrath

CONTACT

905-521-2100; mcgram2@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2015
• First Posted: July 31, 2015
• Study Start: July 1, 2016
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: March 15, 2023

Record last verified: 2023-03

Locations

CA (4)