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

Sponsor

Isfahan University of Medical Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT02752308

Collaborator

(none)

Enrollment

Arms

5.9

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypospadias	Drug: Bupivacaine Procedure: General anesthesia Drug: Dilute epinephrine injection Drug: Fentanyl Drug: dextrose plus sodium chloride. Drug: neostigmine and atropine Procedure: Hypospadias repair	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Sep 1, 2014

Actual Primary Completion Date :

Mar 1, 2015

Actual Study Completion Date :

Mar 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: General anesthesia + caudal block 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 Injection of Bupivacaine in the epidural space (0.25%, 0.33mg/Kg) Other Names: Caudal block 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
Active Comparator: General anesthesia only 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 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

Arm

Intervention/Treatment

Active Comparator: General anesthesia + caudal block

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

Injection of Bupivacaine in the epidural space (0.25%, 0.33mg/Kg)

Other Names:

Caudal block

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

Active Comparator: General anesthesia only

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

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

Outcome Measures

Primary Outcome Measures

Intraoperative blood loss [During procedure]
The amount of blood loss during the operation

Secondary Outcome Measures

Dose of fentanyl used [during the operation]
operation time [during procedure]

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Months to 15 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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