Ultrasound Guided Quadratus Lumborum Block Versus Caudal Block in Pediatric Patient

Not Applicable

Completed

• Conditions: Postoperative Pain
• Interventions: Procedure: Caudal block; Procedure: Quadratus lumborum block

• Registration Number: NCT03294291
• 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 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2017-09-22
• Study First Submitted QC: 2017-09-26
• Study First Posted: 2017-09-27
• Study Start: 2017-12-01
• Status Verified: 2018-11
• Primary Completion: 2018-11-15
• Study Completion: 2018-11-15
• Last Update Submitted: 2018-11-15
• Last Update Posted: 2018-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Caudal block	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 caudal block wil performe with bupivacaine 0.7 ml/kg as 0.25%.
Quadratus Lumborum block group	Quadratus lumborum 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. Under ultrasound guidance a 22 Gauge, Pajunk Sonoplex(medical Germany) needle will be used for both techniques. Under ultrasound 0.7 ml/kg bupivacaine 0.25 % injected unilaterally at the posterior border of the quadratus lumborum muscle.

Primary Outcome Measures

Name	Time	Method
Use of analgesic consumption	24 hour	paracetamol

Secondary Outcome Measures

Name	Time	Method
Flacc score( face, legs, activity, cry, consolability)	1,2,4,6,12,24 hou	By investigators until hospital discharge, then through telephone interview with parents after that
Time to first use of analgesic	24 hour	By investigators until hospital discharge, then through telephone interview with parents after that
Parent satisfaction scores	24 hour	By investigators until hospital discharge, then through telephone interview with parents after that

Trial Locations

Locations (1)

KahramanmarasSIU; 🇹🇷 Kahramanmaraş, Turkey