Effectiveness of Caudal Epidural Block on Intraoperative Blood Loss During Hypospadias Repair

Study Overview
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Brief Summary
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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.

Official Title
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Effectiveness of Caudal Epidural Block on Intraoperative Blood Loss During Hypospadias Repair; A Randomized Clinical Trial

Conditions
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Hypospadias

Intervention / Treatment
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* Drug: Bupivacaine
* Procedure: General anesthesia
* Drug: Dilute epinephrine injection
* Drug: Fentanyl
* Drug: dextrose plus sodium chloride.
* Drug: neostigmine and atropine
* Procedure: Hypospadias repair


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age between 6 months to 15 years and hypospadias with any severity Exclusion Criteria: coagulopathy, history of previous failed surgery, skin infection , parents' disagreement with the protocol and any cardiac problem that made epinephrine injection contraindicated

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 15 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: General anesthesia + caudal block<br>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 | Drug: Bupivacaine<br>* Injection of Bupivacaine in the epidural space (0.25%, 0.33mg/Kg)<br>* Other names: Caudal block;Drug: Dilute epinephrine injection<br>* Injection of 1/100000 epinephrine solution along all incision lines<br>Drug: Fentanyl<br>* fentanyl 2 mcg /Kg that is repeated during surgery whenever the heart rate or blood pressure increased more than 20% of its baseline<br>Drug: dextrose plus sodium chloride.<br>* Four mL/Kg/hr of 5% dextrose plus 0.04 mL/Kg/hr of 20% sodium chloride. Each mL of blood loss was replaced by 3 ml of Ringer's solution<br>Drug: neostigmine and atropine<br>* Injection of 0.04 mg/Kg of neostigmine and 0.02 mg/Kg of atropine, intravenously at the end of operation.<br>Procedure: Hypospadias repair<br>* Surgical repair of hypospadias, using tubularized incised plate technique<br>|
| Active Comparator: General anesthesia only<br>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 | Procedure: General anesthesia<br>* Induction with thiopental sodium 5 mg/Kg, atracurium 0.4 mg/Kg and fentanyl 2 mcg/Kg and maintenance with isoflurane and a combination of oxygen and nitrous oxide<br>Drug: Dilute epinephrine injection<br>* Injection of 1/100000 epinephrine solution along all incision lines<br>Drug: Fentanyl<br>* fentanyl 2 mcg /Kg that is repeated during surgery whenever the heart rate or blood pressure increased more than 20% of its baseline<br>Drug: dextrose plus sodium chloride.<br>* Four mL/Kg/hr of 5% dextrose plus 0.04 mL/Kg/hr of 20% sodium chloride. Each mL of blood loss was replaced by 3 ml of Ringer's solution<br>Drug: neostigmine and atropine<br>* Injection of 0.04 mg/Kg of neostigmine and 0.02 mg/Kg of atropine, intravenously at the end of operation.<br>Procedure: Hypospadias repair<br>* Surgical repair of hypospadias, using tubularized incised plate technique<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative blood loss | The amount of blood loss during the operation | During procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose of fentanyl used |  | during the operation | 
| operation time |  | during procedure |