NCT02752308

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

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Isfahan University of Medical Sciences · Academic / Other
• Sex: Male
• Age: 6 Months – 15 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypospadias

Interventions

Type	Name	Description
DRUG	Bupivacaine	Injection of Bupivacaine in the epidural space (0.25%, 0.33mg/Kg)
PROCEDURE	General anesthesia	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
DRUG	Dilute epinephrine injection	Injection of 1/100000 epinephrine solution along all incision lines
DRUG	Fentanyl	fentanyl 2 mcg /Kg that is repeated during surgery whenever the heart rate or blood pressure increased more than 20% of its baseline
DRUG	dextrose plus sodium chloride.	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
DRUG	neostigmine and atropine	Injection of 0.04 mg/Kg of neostigmine and 0.02 mg/Kg of atropine, intravenously at the end of operation.
PROCEDURE	Hypospadias repair	Surgical repair of hypospadias, using tubularized incised plate technique

Timeline

• Start date: 2014-09-01
• Primary completion: 2015-03-01
• Completion: 2015-03-01
• First posted: 2016-04-26
• Last updated: 2016-04-26