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Clinical Trials/NCT02715999
NCT02715999CompletedNot Applicable

Transversus Abdominis Plane Versus Quadratus Lumborum Block for Pediatrics

Kahramanmaras Sutcu Imam University1 site in 1 country50 target enrollmentStarted: February 1, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
50
Locations
1
Primary Endpoint
time to first use of analgesic

Study Overview

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 of trunk block; Transversus abdominis plane 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 1-7 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 Transversus abdominis plane block at the begin of surgery.

All patients will be in the lateral position . Under ultrasound guidance a 22 Gauge, Pajunk Sonoplex(medical Germany) needle will be used for both techniques. The spread of injectate will be seed on ultrasound.The dose of local anaesthetic in both groups will be 0.5 ml/kg 0.2 % Bupivacaine. Anesthesia would be maintained with 2% sevoflurane An increase in blood pressure or heart rate by more than 15% from preoperative value was defined as insufficient analgesia and was treated with fentanyl 0.5 µ/kg. Saline dextrose 5% (1:1) solution was infused in a dose of 12 ml/ kg /h.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
1 Year to 7 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •ASA physical status I-II
  • •undergoing unilateral low abdominal surgery

Exclusion Criteria

  • •history of allergic reactions to local anesthetics
  • •rash or infection at the injection site
  • •anatomical abnormality
  • •bleeding diatheses, coagulopathy, liver diseases

Arms & Interventions

Quadratus Lumborum Block

Active Comparator

Quadratus Lumborum block group (QL) patients will receive unilaterally Quadratus Lumborum block using Bupivacaine 0.2 %

Intervention: Quadratus Lumborum Block (Procedure)

Transversus abdominis plane block

Active Comparator

Transversus abdominis plane block (TAP) patients will receive unilaterally TAP block using Bupivacaine 0.2 %

Intervention: Transversus Abdominis Plane Block (Procedure)

Outcomes

Primary Outcomes

time to first use of analgesic

Time Frame: 24 hour

By investigators until hospital discharge, then through telephone interview with parents after that

Secondary Outcomes

  • Parent satisfaction scores(24 hour)
  • Total paracetamol consumption(24 hour)
  • FLACC (face, legs, activity, cry, consolability)(1,2,4,6,12,24 hour)

Investigators

Sponsor
Kahramanmaras Sutcu Imam University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Gözen Öksüz

Associate Professor

Kahramanmaras Sutcu Imam University

Study Sites (1)

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