Ultrasound-guided PNB and DPNB for Pediatric Distal Hypospadias Surgery

Study Overview
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Brief Summary
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Hypospadias repair is a urological surgical operation that is very painful in the postoperative period and requires long-term analgesia. A dorsal penial nerve block (DPNB) and pudendal nerve block (PNB), which are regional anesthesia techniques for this operation, are used to provide postoperative analgesia.

Detailed Description
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The regional anesthesia techniques used for postoperative analgesia in hypospadias repair include the peripheral nerve blocks of pudendal nerve block (PNB) and dorsal penile nerve block (DPNB). Ultrasound (US) has recently become increasingly popular in regional anesthesia practice and is used to aid these two peripheral nerve block applications in various pediatric urological procedures. US-guided DPNB has been shown to provide effective and long-term analgesia when compared to caudal epidural block in a recent study on hypospadias surgery in the pediatric population.

Official Title
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Ultrasound-guided Pudendal Nerve Block Versus Ultrasound-guided Dorsal Penile Nerve Block for Pediatric Distal Hypospadias Surgery

Conditions
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Regional Anesthesia, Hypospadias

Intervention / Treatment
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* Procedure: Pudendal nerve block group
* Procedure: Dorsal penile nerve block group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male patients aged between 1-7 years American Society of Anesthesiologists (ASA) I-II group Distal hypospadias surgery Able to communicate in Turkish Willing to participate to the study (parents and children) Exclusion Criteria: Less than 1 or more than 7 years of age A neurological deficit, bleeding diathesis, or a history of local anesthetic allergy; an infection or redness in the injection area, congenital low back anomaly, liver disorder, a psychiatric disorder, mental retardation, or communication problems detected during examination Unwilling to to participate to the study ((parents or children)

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 7 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pudendal Nerve Block<br>Linear ultrasound probe and the sacral hiatus at the sacral cornu level was visualized using an out-of-plane transverse view at 5-10 megahertz . The linear probe was then rotated 90 degrees and placed longitudinally in the midline to evaluate the sacral cornus, sacrococcygeal ligament and sacral bone. | Procedure: Pudendal nerve block group<br>* A 22 Gauge 50 mm insulated needle was then introduced in the anterior-posterior direction at the middle of the ultrasound probe's superior edge with an out-of-plane approach and using an inclination of 15° in the sagittal plane. The needle tip's position was identified by direct visualization using the movement of adjacent anatomical structures.<br>|
| Dorsal Penile Nerve Block<br>Ultrasound (US) guided dorsal penile nerve block with in plane technique was done. Half of the total 0.2 ml/kg dose of 0.25% bupivacaine was administered while observing its distribution with US. The same procedure was then repeated on the other side of the penis. | Procedure: Dorsal penile nerve block group<br>* Half of the total 0.2 ml/kg dose of 0.25% bupivacaine was administered while observing its distribution with US. The same procedure was then repeated on the other side of the penis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of Postoperative analgesic requirement | It was assessed six times after the operation with Children's Hospital Eastern Ontario Pain Scale. The lowest scale score is 4 points and the highest 13 points. Significant pain behavior for Children's Hospital Eastern Ontario Pain Scale has been identified as 7 points or more. Following transfer from the recovery unit to the ward, the 1st, 2nd, 6th, 12th and 24th hour pain levels were evaluated by the ward nurse. Paracetamol was administered IV at a dose of 10 mg/kg if the scale score was 7 or higher. | Up to 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of Postoperative pain | It was assessed six times after the operation with Children's Hospital Eastern Ontario Pain Scale. The lowest scale score is 4 points and the highest 13 points. Significant pain behavior for Children's Hospital Eastern Ontario Pain Scale has been identified as 7 points or more. Following transfer from the recovery unit to the ward, the 1st, 2nd, 6th, 12th and 24th hour pain levels were evaluated by the ward nurse | Up to 24 hours] | 
| Rate of Postoperative complications | The presence of penile edema or an injection site ecchymosis or hematoma was evaluated by an anesthesiologist blinded to the study groups postoperatively (at 30 minutes and 1, 2, 6, 12, 18 and 24 hours). | Up to 24 hours | 
| Level of Parent satisfaction | The parents were asked about their satisfaction with the child's comfort and activity level [1, unsatisfied; 2, satisfied (good); 3, absolutely satisfied (excellent)] at the 24-hour follow-up | Up to 24 hours | 

 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 nerve block, Hypospadias