Comparison Sacral Erector Spinae Block Versus Caudal Block

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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Procedure: Ultrasound Guided Caudal Block; Procedure: Sacral Erector Spinae Block

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.

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Kahramanmaras, Turkey
    • Kahramanmaras Sutcu Imam University Hospital
  • Kocaeli, Turkey
    • Kocaeli University Hospital
  • İstanbul, Turkey
    • Koç University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 9 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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%.	Procedure: Ultrasound Guided Caudal Block; Postoperative pain procedure; Procedure: Sacral Erector Spinae Block; Postoperative pain procedure
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%.	Procedure: Ultrasound Guided Caudal Block; Postoperative pain procedure; Procedure: Sacral Erector Spinae Block; Postoperative pain procedure

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Kahramanmaras Sutcu Imam University
• Collaborators: Koç University; Kocaeli University
• Investigators: Principal Investigator: Can Aksu, M.D., Kocaeli University; Principal Investigator: Yavuz Gürkan, Professor, Koc University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2019
• Primary Completion (Actual): February 29, 2020
• Study Completion (Actual): February 29, 2020

Study Registration Dates

• First Submitted: September 25, 2019
• First Submitted That Met QC Criteria: September 25, 2019
• First Posted (Actual): September 27, 2019

Study Record Updates

• Last Update Posted (Actual): March 3, 2020
• Last Update Submitted That Met QC Criteria: February 29, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 2019/12-16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No