Effectiveness of Caudal Epidural Block on Intraoperative Blood Loss During Hypospadias Repair
NCT ID: NCT02752308
Last Updated: 2016-04-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2/PHASE3
60 participants
INTERVENTIONAL
2014-09-30
2015-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Does Caudal Block Increase the Incidence of Urethrocutaneous Fistula Formation Following Hypospadias Repair in Infants?
NCT02861950
Hemostasis During Hypospadias Surgery
NCT02268019
Effect of Caudal and Penile Block on Hypospadias Repair Complications
NCT02851290
Effect of Caudal vs. Penile Block on the Incidence of Hypospadias Complications
NCT06667947
Caudal Anesthesia Versus Local Anesthesia in Hypospadias
NCT06417060
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
Bupivacaine
Injection of Bupivacaine in the epidural space (0.25%, 0.33mg/Kg)
Dilute epinephrine injection
Injection of 1/100000 epinephrine solution along all incision lines
Fentanyl
fentanyl 2 mcg /Kg that is repeated during surgery whenever the heart rate or blood pressure increased more than 20% of its baseline
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
neostigmine and atropine
Injection of 0.04 mg/Kg of neostigmine and 0.02 mg/Kg of atropine, intravenously at the end of operation.
Hypospadias repair
Surgical repair of hypospadias, using tubularized incised plate technique
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
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
Dilute epinephrine injection
Injection of 1/100000 epinephrine solution along all incision lines
Fentanyl
fentanyl 2 mcg /Kg that is repeated during surgery whenever the heart rate or blood pressure increased more than 20% of its baseline
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
neostigmine and atropine
Injection of 0.04 mg/Kg of neostigmine and 0.02 mg/Kg of atropine, intravenously at the end of operation.
Hypospadias repair
Surgical repair of hypospadias, using tubularized incised plate technique
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Bupivacaine
Injection of Bupivacaine in the epidural space (0.25%, 0.33mg/Kg)
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
Dilute epinephrine injection
Injection of 1/100000 epinephrine solution along all incision lines
Fentanyl
fentanyl 2 mcg /Kg that is repeated during surgery whenever the heart rate or blood pressure increased more than 20% of its baseline
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
neostigmine and atropine
Injection of 0.04 mg/Kg of neostigmine and 0.02 mg/Kg of atropine, intravenously at the end of operation.
Hypospadias repair
Surgical repair of hypospadias, using tubularized incised plate technique
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
6 Months
15 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Isfahan University of Medical Sciences
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Farshid Alizadeh
Associate Professor
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
393854
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.