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Trial record 4 of 7 for:    "Hypospadias" | "Autonomic Agents"

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

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ClinicalTrials.gov Identifier: NCT02752308
Recruitment Status : Completed
First Posted : April 26, 2016
Last Update Posted : April 26, 2016
Sponsor:
Information provided by (Responsible Party):
Farshid Alizadeh, Isfahan University of Medical Sciences

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

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Study Type : Interventional  (Clinical Trial)
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 : September 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

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 Name: 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




Primary Outcome Measures :
  1. Intraoperative blood loss [ Time Frame: During procedure ]
    The amount of blood loss during the operation


Secondary Outcome Measures :
  1. Dose of fentanyl used [ Time Frame: during the operation ]
  2. operation time [ Time Frame: during procedure ]


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 15 Years   (Child)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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


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Responsible Party: Farshid Alizadeh, Associate Professor, Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT02752308     History of Changes
Other Study ID Numbers: 393854
First Posted: April 26, 2016    Key Record Dates
Last Update Posted: April 26, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Hypospadias
Autonomic Agents
Penile Diseases
Genital Diseases, Male
Urogenital Abnormalities
Congenital Abnormalities
Atropine
Epinephrine
Racepinephrine
Fentanyl
Anesthetics
Bupivacaine
Epinephryl borate
Neostigmine
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Analgesics
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action