Hypospadias Clinical Trial
Official title:
Effectiveness of Caudal Epidural Block on Intraoperative Blood Loss During Hypospadias Repair; A Randomized Clinical Trial
From September 2014 to March 2015, 57 consecutive patients with hypospadias who are
candidate for surgery will be enrolled in this randomized clinical trial.
Regional ethics committee of Isfahan University of Medical Sciences approved the protocol of
the study and all parents will sign a written informed consent.
Inclusion criteria are age between 6 months to 15 years and hypospadias with any severity.
Exclusion criteria are coagulopathy, history of previous failed surgery, skin infection ,
parents' disagreement with the protocol and any cardiac problem that made epinephrine
injection contraindicated.
All selected patients will randomly allocate to one of the two groups: group A will receive
caudal epidural block (CEB) plus general anesthesia before surgery and group B will receive
general anesthesia before surgery and CEB afterwards. The surgical procedures will be
performed by a single pediatric urologist (FA). The surgical technique will be tubularized
incised plate in all cases.
Intraoperative blood loss will be determined by weighing all surgical gauzes used during
procedure with a digital scale measure to the nearest 0.01 gram, every 10 minutes to
minimize the effect of water vaporization on gauzes weights.
In addition to blood loss, operation time, dose of fentanyl used during procedure and length
of the urethral plate defect will be recorded for each patient by trained nurses.
Demographics and disease characteristics as well as operation details will be compared in
the two studied groups.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
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