Comparison Sacral Erector Spinae Block Versus Caudal Block

Not Applicable

Completed

• Conditions: Postoperative Pain
• Interventions: Procedure: Ultrasound Guided Caudal Block; Procedure: Sacral Erector Spinae Block

• Registration Number: NCT04106687
• Lead Sponsor: Kahramanmaras Sutcu Imam University

Brief Summary

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

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 Timeline

• Study First Submitted: 2019-09-25
• Study First Submitted QC: 2019-09-25
• Study Start: 2019-09-27
• Study First Posted: 2019-09-27
• Status Verified: 2020-02
• Primary Completion: 2020-02-29
• Study Completion: 2020-02-29
• Last Update Submitted: 2020-02-29
• Last Update Posted: 2020-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 44

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Caudal Block	Ultrasound Guided 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%.
Sacral Erector Spinae Block	Ultrasound Guided 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 sacral erector spinae block wil performe with bupivacaine 1 ml/kg as 0.25%.
Caudal Block	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 caudal block wil performe with bupivacaine 1 ml/kg as 0.25%.
Sacral Erector Spinae Block	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%.

Primary Outcome Measures

Name	Time	Method
Number of analgesic consumption	24 hour	Acetaminophen and Fentanly

Secondary Outcome Measures

Name	Time	Method
Face, Legs, Activity, Cry and Consolability Score (FLACC)	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	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).

Trial Locations

Locations (3)

Koç University Hospital; 🇹🇷 İstanbul, Turkey

Kocaeli University Hospital; 🇹🇷 Kocaeli, Turkey

Kahramanmaras Sutcu Imam University Hospital; 🇹🇷 Kahramanmaras, Turkey