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

NCT02752308 | Completed Phase 2

• 1 other identifier: 393854
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hypospadias

Outcome Measures

Primary Outcomes (1)

• Intraoperative blood loss

  The amount of blood loss during the operation

  During procedure

Secondary Outcomes (2)

• Dose of fentanyl used

  during the operation

• operation time

  during procedure

Study Arms (2)

General anesthesia + caudal block

ACTIVE COMPARATOR

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

General anesthesia only

ACTIVE COMPARATOR

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

Interventions

Bupivacaine DRUG

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

Also known as: Caudal block

General anesthesia + caudal block

General anesthesia PROCEDURE

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

General anesthesia only

Dilute epinephrine injection DRUG

Injection of 1/100000 epinephrine solution along all incision lines

General anesthesia + caudal block; General anesthesia only

Fentanyl DRUG

fentanyl 2 mcg /Kg that is repeated during surgery whenever the heart rate or blood pressure increased more than 20% of its baseline

General anesthesia + caudal block; General anesthesia only

dextrose plus sodium chloride. DRUG

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

General anesthesia + caudal block; General anesthesia only

neostigmine and atropine DRUG

Injection of 0.04 mg/Kg of neostigmine and 0.02 mg/Kg of atropine, intravenously at the end of operation.

General anesthesia + caudal block; General anesthesia only

Hypospadias repair PROCEDURE

Surgical repair of hypospadias, using tubularized incised plate technique

General anesthesia + caudal block; General anesthesia only

Eligibility Criteria

• Age: 6 Months - 15 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• age between 6 months to 15 years and hypospadias with any severity

You may not qualify if:

• coagulopathy, history of previous failed surgery, skin infection , parents' disagreement with the protocol and any cardiac problem that made epinephrine injection contraindicated

Sponsors & Collaborators

• Isfahan University of Medical Sciences: lead

MeSH Terms

Conditions

Hypospadias

Interventions

Bupivacaine; Anesthesia, General; Fentanyl; Glucose; Sodium Chloride; Neostigmine; Atropine

Condition Hierarchy (Ancestors)

Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Penile Diseases; Genital Diseases, Male; Genital Diseases; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Anesthesia; Anesthesia and Analgesia; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Hexoses; Monosaccharides; Sugars; Carbohydrates; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Phenylammonium Compounds; Quaternary Ammonium Compounds; Onium Compounds; Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 20, 2016
• First Posted: April 26, 2016
• Study Start: September 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: April 26, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share