Ultrasound Guided Quadratus Lumborum Block Versus Caudal Block in Pediatric Patient

Postoperative Pain Clinical Trial

Official title:

Quadratus Lumborum Block Versus Caudal Block

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03294291
• Other study ID #: 2017/10-08
• Status: Completed
• Phase: N/A
• Start date: December 1, 2017
• Est. completion date: November 15, 2018

Study information

• Verified date: November 2018
• 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 low abdominal surgery. Investigators will perform two technique;Caudal block or Quadratus lumborum block .The method used is often chosen by which one the doctor has more experience using. The Investigator plans to find out if one of the methods is more effective and/or safer than the other method.

The results of this study will help learn how to best control pain in children having surgery low abdominal surgery.

Description:

Children aged 1-9 years undergoing lower abdominal 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 unilaterally low abdominal surgery(inguinal hernia,hydrocele,undescended testicles surgery will be randomised to unilateral Quadratus lumborum 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 and Modified Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) score will be used.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: November 15, 2018
• Est. primary completion date: November 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• 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

1. renal

2. hepatic

3. cardiac

4. upper or lower airway

5. neurological

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Procedure:
• Quadratus lumborum block
Postoperative pain procedure
• Caudal block
Postoperative pain procedure

Locations

Country	Name	City	State
Turkey	KahramanmarasSIU	Kahramanmaras

Sponsors (1)

Lead Sponsor	Collaborator
Kahramanmaras Sutcu Imam University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Öksüz G, Bilal B, Gürkan Y, Urfalioglu A, Arslan M, Gisi G, Öksüz H. Quadratus Lumborum Block Versus Transversus Abdominis Plane Block in Children Undergoing Low Abdominal Surgery: A Randomized Controlled Trial. Reg Anesth Pain Med. 2017 Sep/Oct;42(5):674 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Use of analgesic consumption	paracetamol	24 hour
Secondary	Flacc score( face, legs, activity, cry, consolability)	By investigators until hospital discharge, then through telephone interview with parents after that	1,2,4,6,12,24 hou
Secondary	Parent satisfaction scores	By investigators until hospital discharge, then through telephone interview with parents after that	24 hour
Secondary	Time to first use of analgesic	By investigators until hospital discharge, then through telephone interview with parents after that	24 hour