Clinical Trial: Caudal vs Local Anesthesia in Hypospadias

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Caudal vs Local Anesthesia in Hypospadias: The CLASH Study

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.

Detailed Summary:
Sponsor: McMaster University

Current Primary Outcome: Post-operative Complication Rate [ Time Frame: Follow-up to assess the complications, specifically urethrocutaneous fistula (UCF) and glans dehiscence within 12 months post-surgery. ]

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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Operating Room (OR) time [ Time Frame: Record duration of operative time (takes on average 30-45 minutes) ]
    OR time will be measured in minutes from the time the patient enters the OR to the time surgery is complete
  • Complications directly related to caudal block [ Time Frame: Complications will be measured at a clinic visit 48 hours after surgery. ]
    Complications directly related to caudal block include block failure, blood aspiration and intravascular injections.
  • Complications directly related to dorsal penile block [ Time Frame: Complications will be measured at a clinic visit 48 hours after surgery. ]
    Complications directly related to dorsal penile block include hematoma and intravascular injection.
  • Post-operative Pain [ Time Frame: Measure at patient admission and discharge at 30 minute intervals. ]
    Pain scores will be measured through a reliable and validated observer-rated Face, Legs, Activity, Cry, Consolability (FLACC) Behavioural Scale by two trained, blinded, and independent study personnel. Both study personnel will measure pain at admission and discharge during the recovery phase.
  • Post-operative Pain [ Time Frame: Measure at patient admission and discharge at 30 minute intervals. ]
    Pain scores will be measured through a reliable and validated observer-rated Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) by two trained, blinded, and independent study personnel. Both study personnel will measure pain at admission and discharge during the recovery phase.


Original Secondary Outcome: Same as current

Information By: McMaster University

Dates:
Date Received: July 27, 2015
Date Started: July 2016
Date Completion: July 2017
Last Updated: October 14, 2016
Last Verified: October 2016