Comparison of Erector Spinae Plane Block and Penile Block in Hypospadias Surgery

Study Overview
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Brief Summary
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In this study, we aimed to compare ultrasound-guided sacral erector spinae plane block and dorsal penile block on postoperative analgesic effect in hypospadias surgery.

Detailed Description
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ASAI-II, 1-9 years old patients with hypospadias diagnosis and operated in Kahramanmaraş Sütçü İmam University hospital and Kocaeli University hospital were randomized with closed envelope technique and divided into two groups as penile block or erector spinae plane block. Erector spinae plane block or penile block application (by Gözen Öksüz, Can Aksu) will be performed after the patients give standard general anesthesia and a laryngeal mask is applied. Vital signs such as pulse, sp02, blood pressure will be monitored before, during and at the end of the operation. At the end of the operation and after the patient is awakened 5. min., 30 min. 1., 2., 4., 6., 12., 24. hourly FLACC pain scores, number of analgesic use within 24 hours, patient family satisfaction (1: dissatisfied, 2: satisfied, 3: very satisfied), complication rates will be recorded.

Official Title
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Comparison of Sacral Erector Spinae Plane Block and Dorsal Penile Block in Pain Management in Patients Undergoing Hypospadias Surgery

Conditions
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Postoperative Pain, Analgesia

Intervention / Treatment
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* Procedure: The ultrasound-guided Sacral Erector spinae plane block
* Procedure: The dorsal penile block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiology Classification (ASA) I-II, 1-9 years aged patients patients who scheuled elective hypospadias surgery in Kahramanmaraş Sütçü İmam University Hospital and Kocaeli University Hospital Exclusion Criteria: American Society of Anesthesiology Classification (ASA) III-IV, patients with coagulopathy patients with infection at the injection site

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 9 Years

Sexes Eligible for Study
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All

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: The erector spinae plane block<br>The ultrasound-guided Erector spinae plane block (ESPB) with 1 ml/kg 0,25 % bupivacaine at the lumbar vertebral level will perform before surgery to all patients in the ESPB group. | Procedure: The ultrasound-guided Sacral Erector spinae plane block<br>* postoperative pain procedure<br>|
| Active Comparator: The penile block<br>The penile block with 0,5ml/kg 0,25 % bupivacaine will be performed after the patients give standard general anesthesia and a laryngeal mask is applied. | Procedure: The dorsal penile block<br>* postoperative pain procedure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FLACC score | At the end of the operation and after the patient is awakened 5th min., 30th min., 1st, 2nd, 4th, 6th, 12th, 24th Hourly FLACC pain scores will be recorded. | during postoperative 24 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Regional anaesthesia, Pediatric anesthesia, Erector spinae plane block, Penil block