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NCT Number: NCT02715999

Transversus Abdominis Plane Versus Quadratus Lumborum Block for Pediatrics

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.

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

1 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kahramanmaras Sutcu Imam University Hospital

Kahramanmaraş, Turkey (Türkiye)

About this study

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.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

quadratus lumborum block

Procedure

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.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. Under ultrasound 0.5 ml/kg bupivacaine 0.2 % injected unilaterally at the posterior border of the quadratus lumborum muscle

Other names: QLB

transversus abdominis plane block

Procedure

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. 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. Under ultrasound 0.5 ml/kg bupivacaine 0.2 % injected unilaterally between internal oblique and transversus abdominis muscles.

Other names: TAP

Primary outcomes

  1. 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

  1. Total paracetamol consumption

    Time frame: 24 hour

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

  2. Parent satisfaction scores

    Time frame: 24 hour

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

  3. FLACC (face, legs, activity, cry, consolability)

    Time frame: 1,2,4,6,12,24 hour

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

Sponsors and collaborators

Lead sponsor

Kahramanmaras Sutcu Imam University

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 22, 2016
Registry last updated
Nov 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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