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Completed

NCT Number: NCT03294291

Ultrasound Guided Quadratus Lumborum Block Versus Caudal Block in Pediatric Patient

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.

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Key information

Age range

1 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

KahramanmarasSIU

Kahramanmaraş, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 1-9
  • ASA physical status I-II
  • Undergoing unilateral low abdominal surgery

Exclusion criteria

  • History of developmental delay or mental retardation, which will make observational pain intensity assessment difficult
  • Parent refusal
  • History of allergic reactions to local anesthetics
  • Rash or infection at the injection site
  • Anatomical abnormality
  • Bleeding diatheses
  • Coagulopathy,
  • History of diseases
  • renal
  • hepatic
  • cardiac
  • upper or lower airway
  • neurological

Treatment and study plan

quadratus lumborum block

Procedure

Postoperative pain procedure

Caudal block

Procedure

Postoperative pain procedure

Primary outcomes

  1. Use of analgesic consumption

    Time frame: 24 hour

    paracetamol

Secondary outcomes

  1. Flacc score( face, legs, activity, cry, consolability)

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

    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. Time to first use of analgesic

    Time frame: 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

Official study title

Quadratus Lumborum Block Versus Caudal Block

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 27, 2017
Registry last updated
Nov 16, 2018

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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