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Completed

NCT Number: NCT04106687

Comparison Sacral Erector Spinae Block Versus Caudal Block

The purpose of this research study is to find the best way to decrease pain in children whom have had hypospadias surgery. Investigators will perform two technique; Caudal block or Sacral erector spinae block.

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

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Key information

Age range

1 year–9 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Koç University Hospital, Istanbul, Turkey (Türkiye)

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About this study

Children aged 1-9 years undergoing hypospadias 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 hypospadias surgery will be randomised to sacral erector spinae 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 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 neurologica

Treatment and study plan

Ultrasound Guided Caudal Block

Procedure

Postoperative pain procedure

Sacral Erector Spinae Block

Procedure

Postoperative pain procedure

Primary outcomes

  1. Number of analgesic consumption

    Time frame: 24 hour

    Acetaminophen and Fentanly

Secondary outcomes

  1. Face, Legs, Activity, Cry and Consolability Score (FLACC)

    Time frame: 24 hour

    FLACC scale will be used. The Face, Legs, Activity, Cry, Consolability scale or FLACC scale is a measurement used to assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2. FLACC scale will be recorded at postoperative 30 minute, 1,2,4,6,12,24 hour

  2. Parent satisfaction scores

    Time frame: 24 hour

    By investigators until hospital discharge, then through telephone interview with parents after that. Will be scored between 1-3 (1- very bad, 2-good, 3-very good).

Sponsors and collaborators

Lead sponsor

Kahramanmaras Sutcu Imam University

Other

Collaborators

  • Kocaeli University
  • Koç University

Registry information

Official study title

A Randomized Controlled Trial of Sacral Erector Spinae Block Versus Caudal Block for Postoperative Analgesia After Hypospadias Surgery in Children

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 27, 2019
Registry last updated
Mar 3, 2020

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

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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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