Comparison Sacral Erector Spinae Block Versus Caudal Block

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.

Full Title of Study: “A Randomized Controlled Trial of Sacral Erector Spinae Block Versus Caudal Block for Postoperative Analgesia After Hypospadias Surgery in Children”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: February 29, 2020

Detailed Description

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.

Interventions

  • Procedure: Ultrasound Guided Caudal Block
    • Postoperative pain procedure
  • Procedure: Sacral Erector Spinae Block
    • Postoperative pain procedure

Arms, Groups and Cohorts

  • Active Comparator: Caudal Block
    • 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%.
  • Active Comparator: Sacral Erector Spinae Block
    • 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%.

Clinical Trial Outcome Measures

Primary Measures

  • Number of analgesic consumption
    • Time Frame: 24 hour
    • Acetaminophen and Fentanly

Secondary Measures

  • Face, Legs, Activity, Cry and Consolability Score (FLACC)
    • Time Frame: 24 hour
    • 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
  • Parent satisfaction scores
    • Time Frame: 24 hour
    • 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).

Participating in This Clinical Trial

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

Gender Eligibility: Male

Minimum Age: 1 Year

Maximum Age: 9 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Kahramanmaras Sutcu Imam University
  • Collaborator
    • Kocaeli University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Gözen Öksüz, Assistant Professor – Kahramanmaras Sutcu Imam University
  • Overall Official(s)
    • Can Aksu, M.D., Principal Investigator, Kocaeli University
    • Yavuz Gürkan, Professor, Principal Investigator, Koç University

References

Oksuz G, Arslan M, Bilal B, Gisi G, Yavuz C. Ultrasound guided sacral erector spinae block for postoperative analgesia in pediatric anoplasty surgeries. J Clin Anesth. 2020 Mar;60:88. doi: 10.1016/j.jclinane.2019.08.006. Epub 2019 Sep 3. No abstract available.

Aksu C, Gurkan Y. Sacral Erector Spinae Plane Block with longitudinal midline approach: Could it be the new era for pediatric postoperative analgesia? J Clin Anesth. 2020 Feb;59:38-39. doi: 10.1016/j.jclinane.2019.06.007. Epub 2019 Jun 13. No abstract available.

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