Effectiveness of Caudal Epidural Block on Intraoperative Blood Loss During Hypospadias Repair
- Conditions
- Hypospadias
- Interventions
- Procedure: General anesthesiaDrug: dextrose plus sodium chloride.Procedure: Hypospadias repair
- Registration Number
- NCT02752308
- Lead Sponsor
- Isfahan University of Medical Sciences
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 60
age between 6 months to 15 years and hypospadias with any severity
coagulopathy, history of previous failed surgery, skin infection , parents' disagreement with the protocol and any cardiac problem that made epinephrine injection contraindicated
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description General anesthesia + caudal block neostigmine and atropine Patients who receive general anesthesia plus caudal epidural block and dilute epinephrine injection before hypospadias repair, intraoperative fentanyl, intraoperative intravenous fluid and reversing the muscle relaxants' effect at the end of operation General anesthesia only neostigmine and atropine Patients who receive only general anesthesia and dilute epinephrine injection before hypospadias repair, intraoperative fentanyl, intraoperative intravenous fluid and reversing the muscle relaxants' effect at the end of operation General anesthesia + caudal block dextrose plus sodium chloride. Patients who receive general anesthesia plus caudal epidural block and dilute epinephrine injection before hypospadias repair, intraoperative fentanyl, intraoperative intravenous fluid and reversing the muscle relaxants' effect at the end of operation General anesthesia + caudal block Hypospadias repair Patients who receive general anesthesia plus caudal epidural block and dilute epinephrine injection before hypospadias repair, intraoperative fentanyl, intraoperative intravenous fluid and reversing the muscle relaxants' effect at the end of operation General anesthesia + caudal block Bupivacaine Patients who receive general anesthesia plus caudal epidural block and dilute epinephrine injection before hypospadias repair, intraoperative fentanyl, intraoperative intravenous fluid and reversing the muscle relaxants' effect at the end of operation General anesthesia + caudal block Dilute epinephrine injection Patients who receive general anesthesia plus caudal epidural block and dilute epinephrine injection before hypospadias repair, intraoperative fentanyl, intraoperative intravenous fluid and reversing the muscle relaxants' effect at the end of operation General anesthesia only General anesthesia Patients who receive only general anesthesia and dilute epinephrine injection before hypospadias repair, intraoperative fentanyl, intraoperative intravenous fluid and reversing the muscle relaxants' effect at the end of operation General anesthesia only Dilute epinephrine injection Patients who receive only general anesthesia and dilute epinephrine injection before hypospadias repair, intraoperative fentanyl, intraoperative intravenous fluid and reversing the muscle relaxants' effect at the end of operation General anesthesia only dextrose plus sodium chloride. Patients who receive only general anesthesia and dilute epinephrine injection before hypospadias repair, intraoperative fentanyl, intraoperative intravenous fluid and reversing the muscle relaxants' effect at the end of operation General anesthesia only Fentanyl Patients who receive only general anesthesia and dilute epinephrine injection before hypospadias repair, intraoperative fentanyl, intraoperative intravenous fluid and reversing the muscle relaxants' effect at the end of operation General anesthesia only Hypospadias repair Patients who receive only general anesthesia and dilute epinephrine injection before hypospadias repair, intraoperative fentanyl, intraoperative intravenous fluid and reversing the muscle relaxants' effect at the end of operation General anesthesia + caudal block Fentanyl Patients who receive general anesthesia plus caudal epidural block and dilute epinephrine injection before hypospadias repair, intraoperative fentanyl, intraoperative intravenous fluid and reversing the muscle relaxants' effect at the end of operation
- Primary Outcome Measures
Name Time Method Intraoperative blood loss During procedure The amount of blood loss during the operation
- Secondary Outcome Measures
Name Time Method Dose of fentanyl used during the operation operation time during procedure