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

I

Isfahan University of Medical Sciences

Status and phase

Completed
Phase 3
Phase 2

Conditions

Hypospadias

Treatments

Procedure: General anesthesia
Drug: Fentanyl
Drug: dextrose plus sodium chloride.
Procedure: Hypospadias repair
Drug: Dilute epinephrine injection
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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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