Comparison Sacral Erector Spinae Block Versus Caudal Block

Study Overview
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Brief Summary
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The purpose of this research study is to find the best way to decrease pain in children whom have had hypospadias surgery. Investigators will perform two technique; Caudal block or Sacral erector spinae block. The results of this study will help learn how to best control pain in children having surgery hypospadias surgery.

Detailed Description
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Children aged 1-9 years undergoing hypospadias surgeries would be recruited in this randomized study. Children would be monitored by electrocardiogram, pulse oximeter and non-invasive blood pressure. After preoxygenation for three minutes, anesthesia would be induced with 8% sevoflurane inhalation in 50% oxygen and % 50 air ; 1ug/kg fentanyl and 3 mg/kg propofol is administered intravenously. Then laryngeal mask is inserted when conditions are satisfactory (jaw relaxed, lash reflex disappeared, no coughing, gagging, swallowing).After ethical committee approval, informed written consent will be obtained from all patients. Consenting patients scheduled to have hypospadias surgery will be randomised to sacral erector spinae block or caudal block at the begin of surgery. All patients heart rate,MAP and Oxygen saturation record intraoperatively. All patients will receive paracetamol if requirement for postoperative analgesia.All patient will transfer from PACU to day-surgery unit (DSU) if they achieved Modified Aldrete Score of ten. All patients will be assessed postoperatively by a blinded investigator: in the postanesthesia care unit and at 30 min 1,2, 4, 6, 12, 24, hour postoperatively.FLACC score will be used.

Official Title
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A Randomized Controlled Trial of Sacral Erector Spinae Block Versus Caudal Block for Postoperative Analgesia After Hypospadias Surgery in Children

Conditions
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Postoperative Pain

Intervention / Treatment
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* Procedure: Ultrasound Guided Caudal Block
* Procedure: Sacral Erector Spinae Block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 1-9 ASA physical status I-II Undergoing unilateral low abdominal surgery Exclusion Criteria: History of developmental delay or mental retardation, which will make observational pain intensity assessment difficult Parent refusal History of allergic reactions to local anesthetics Rash or infection at the injection site Anatomical abnormality Bleeding diatheses Coagulopathy History of diseases renal hepatic cardiac upper or lower airway neurologica

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 9 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
Interventional Model Description: All Children will be randomly assigned to one of 2 groups of 20 patients each using a computer-generated number table.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Caudal Block<br>After preoxygenation for three minutes, anesthesia would be induced with 8% sevoflurane inhalation in 50% oxygen and % 50 air ; 1ug/kg fentanyl and 3 mg/kg propofol is administered intravenously. Then laryngeal mask is inserted when conditions are satisfactory ultrasound guided caudal block wil performe with bupivacaine 1 ml/kg as 0.25%. | Procedure: Ultrasound Guided Caudal Block<br>* Postoperative pain procedure<br>Procedure: Sacral Erector Spinae Block<br>* Postoperative pain procedure<br>|
| Active Comparator: Sacral Erector Spinae Block<br>After preoxygenation for three minutes, anesthesia would be induced with 8% sevoflurane inhalation in 50% oxygen and % 50 air ; 1ug/kg fentanyl and 3 mg/kg propofol is administered intravenously. Then laryngeal mask is inserted when conditions are satisfactory ultrasound guided sacral erector spinae block wil performe with bupivacaine 1 ml/kg as 0.25%. | Procedure: Ultrasound Guided Caudal Block<br>* Postoperative pain procedure<br>Procedure: Sacral Erector Spinae Block<br>* Postoperative pain procedure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of analgesic consumption | Acetaminophen and Fentanly | 24 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Face, Legs, Activity, Cry and Consolability Score (FLACC) | 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. FLACC scale will be recorded at postoperative 30 minute, 1,2,4,6,12,24 hour | 24 hour | 
| Parent satisfaction scores | By investigators until hospital discharge, then through telephone interview with parents after that. Will be scored between 1-3 (1- very bad, 2-good, 3-very good). | 24 hour |