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

April 25, 2016 updated by: Farshid Alizadeh, Isfahan University of Medical Sciences

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraoperative blood loss
Time Frame: During procedure
The amount of blood loss during the operation
During procedure

Secondary Outcome Measures

Outcome Measure
Time Frame
Dose of fentanyl used
Time Frame: during the operation
during the operation
operation time
Time Frame: during procedure
during procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Isfahan University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

April 20, 2016

First Submitted That Met QC Criteria

April 25, 2016

First Posted (Estimate)

April 26, 2016

Study Record Updates

Last Update Posted (Estimate)

April 26, 2016

Last Update Submitted That Met QC Criteria

April 25, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 393854

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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