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

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

September 30, 2014

Primary Completion Date

March 31, 2015

Study Completion Date

March 31, 2015

Conditions
Hypospadias
Interventions
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

All Listed Sponsors
lead

Isfahan University of Medical Sciences

OTHER

NCT02752308 - Effectiveness of Caudal Epidural Block on Intraoperative Blood Loss During Hypospadias Repair | Biotech Hunter | Biotech Hunter