Comparison Sacral Erector Spinae Block Versus Caudal Block

Kahramanmaras Sutcu Imam University44 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Postoperative Pain

Interventions

Ultrasound Guided Caudal BlockPROCEDURE

Postoperative pain procedure

Sacral Erector Spinae BlockPROCEDURE

Postoperative pain procedure

Eligibility

Sex: MALEMin age: 1 YearMax age: 9 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age 1-9 2. ASA physical status I-II 3. Undergoing unilateral low abdominal surgery Exclusion Criteria: 1. History of developmental delay or mental retardation, which will make observational pain intensity assessment difficult 2. Parent refusal 3. History of allergic reactions to local anesthetics 4. Rash or infection at the injection site 5. Anatomical abnormality 6. Bleeding diatheses 7. Coagulopathy 8. History of diseases renal hepatic cardiac upper or lower airway neurologica

Locations (3)

Koç University Hospital

Istanbul, Turkey (Türkiye)

Kahramanmaras Sutcu Imam University Hospital

Kahramanmaraş, Turkey (Türkiye)

Kocaeli University Hospital

Kocaeli, Turkey (Türkiye)

Outcomes

Primary Outcomes

Number of analgesic consumption

Acetaminophen and Fentanly

Time frame: 24 hour

Secondary Outcomes

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

Time frame: 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).

Time frame: 24 hour

Data from ClinicalTrials.gov

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