Pudendal Block Versus Caudal Block for Hypospadias

Study Overview
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Brief Summary
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The aim of this prospective randomized study is to assess the analgesic efficacy and duration of Pudendal block compared with Caudal block for pediatric patients undergoing hypospadias surgery concerning intraoperative analgesic and also postoperative total analgesic consumption within 24 hours.

Detailed Description
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In this prospective study, patients will be randomized into 2 groups, either receiving Caudal Block(CB) or nerve stimulator-guided Pudendal Nerve Block(PNB). Analgesic consumption will be assessed during the first 24 hours postoperatively. The CHEOPS pain scale will use to assess postoperative pain.

Official Title
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A Comparison of Effectiveness of Pudendal Nerve Block vs Caudal Block for Hypospadias Surgery in Children

Conditions
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Pain

Intervention / Treatment
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* Procedure: pudendal nerve block
* Procedure: caudal block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA physical status I-II aged 1 to 10 years scheduled undergoing hypospadias surgery Exclusion Criteria: history of allergic reactions to local anesthetics rash or infection at the injection site anatomical abnormality bleeding diatheses, coagulopathy, liver diseases

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 10 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: pudendal block group<br>nerve stimulated pudendal nerve block performed under general anesthesia | Procedure: pudendal nerve block<br>* nerve stimulator-guided Pudendal block<br>|
| Active Comparator: Caudal block group<br>caudal block performed under general anesthesia | Procedure: caudal block<br>* caudal block<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative pain intensity measure | pain scores are recorded (postoperative within 24 hours) the investigators use CHEOPS pain scale for evaluation pain intensity. When pain score is 7 or higher than 7, pain treatment is evaluated as inadequate. | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to to first use of analgesic |  | 24 hours | 
| parental satisfaction | Parent satisfaction was scored as: definitely unsatisfied; satisfied; definitely satisfied. | 24 hours | 
| the incidence of side effects |  | 24 hours | 
| intraoperative analgesic requirement | intraoperative remifentanil infusion requirement ( If heart rate and/or blood pressure increase 20% than first measure, we will start remifentanil infusion) | intraoperative | 
| postoperative total analgesic requirements |  | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pudendal block, Hypospadias, caudal block, child, analgesia