Comparison Sacral Erector Spinae Block Versus Caudal Block

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04106687
• Other study ID #: 2019/12-16
• Status: Completed
• Phase: N/A
• Start date: September 27, 2019
• Est. completion date: February 29, 2020

Study information

• Verified date: February 2020
• Source: Kahramanmaras Sutcu Imam University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: February 29, 2020
• Est. primary completion date: February 29, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 1 Year to 9 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

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

Locations

Country	Name	City	State
Turkey	Koç University Hospital	Istanbul
Turkey	Kahramanmaras Sutcu Imam University Hospital	Kahramanmaras
Turkey	Kocaeli University Hospital	Kocaeli

Sponsors (3)

Lead Sponsor	Collaborator
Kahramanmaras Sutcu Imam University	Koç University, Kocaeli University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Aksu C, Gürkan 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. — View Citation

Öksüz 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of analgesic consumption	Acetaminophen and Fentanly	24 hour
Secondary	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
Secondary	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