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

Isfahan University of Medical Sciences

Status and phase: Completed; Phase 3; Phase 2

Conditions: Hypospadias

Treatments: Drug: dextrose plus sodium chloride.; Drug: Fentanyl; Procedure: General anesthesia; Drug: Dilute epinephrine injection; Procedure: Hypospadias repair; Drug: neostigmine and atropine; Drug: Bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT02752308

393854

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: Male

Ages: 6 months to 15 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

General anesthesia + caudal block

Active Comparator group

Description:

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

Treatment:

Drug: Bupivacaine

Drug: dextrose plus sodium chloride.

Drug: Fentanyl

Procedure: Hypospadias repair

Drug: neostigmine and atropine

Drug: Dilute epinephrine injection

General anesthesia only

Active Comparator group

Description:

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

Treatment:

Drug: dextrose plus sodium chloride.

Drug: Fentanyl

Procedure: General anesthesia

Procedure: Hypospadias repair

Drug: neostigmine and atropine

Drug: Dilute epinephrine injection