Ultrasound Guided Penile Block vs Pudendal Block for Hypospadias

Study Overview
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Brief Summary
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Pain after hypospadias surgery is a challenging issue to solve for anesthesists. Many different analgesia techniques were defined in literature for this purpose. The investigators have implemented application of ultrasound guided dorsal penile nerve block into practice for these type of surgeries. Main purpose of this study is to compare the efficacy of nerve stimulator guided pudendal nerve block with ultrasound guided dorsal penile nerve block for postoperative analgesia after hypospadias surgery.

Official Title
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Ultrasound Guided Dorsal Penile Block vs Neurostimulator Guided Pudendal Block in Children Undergoing Hypospadias Surgery: A Prospective, Randomized, Double-Blind Trial

Conditions
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Postoperative Pain

Intervention / Treatment
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* Procedure: Penile Block
* Procedure: Pudendal Block
* Drug: Bupivacaine (Block Drug)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1 to 10 years of age ASA I-II Undergoing elective hypospadias surgery Exclusion Criteria: infection of the skin at the site of needle puncture area patients with known allergies to any of the study drugs coagulopathy ASA III-IV Patients with neurological disorders

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: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Penile Block<br>Ultrasound guided dorsal penile nerve block will be administered after general anesthesia. 0,25% Bupivacaine 0,5ml/kg (max. 20ml) will be used for the blocks | Procedure: Penile Block<br>* Ultrasound guided dorsal penile nerve block will be done to this group of patients preoperatively, under general anesthesia. 0,25% Bupivacaine 0,5ml/kg (max. 20ml)<br>Drug: Bupivacaine (Block Drug)<br>* Block drug<br>|
| Active Comparator: Pudendal Block<br>Nerve stimulator-guided pudendal block. 0,25% Bupivacaine 0,5ml/kg (max. 20ml) will be used for the blocks | Procedure: Pudendal Block<br>* Nerve stimulation guided bilateral pudendal block will be done to this group of patients preoperatively, under general anesthesia. 0,25% Bupivacaine 0,5ml/kg (max. 20ml)<br>Drug: Bupivacaine (Block Drug)<br>* Block drug<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first analgesic | First need for rescue analgesic after the surgery will be recorded | postoperative 7 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Scores | FLACC scale will be used. The Face, Legs, Activity, Cry, Consolability scale or FLACC scale is a measurement used to assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2. | postoperative 48 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postoperative pain, Ultrasound, Dorsal Penile Nerve Block, Pudendal Block, Hypospadias