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Clinical Trials/NCT04106687
NCT04106687
Completed
N/A

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

Kahramanmaras Sutcu Imam University3 sites in 1 country44 target enrollmentSeptember 27, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Postoperative Pain
Sponsor
Kahramanmaras Sutcu Imam University
Enrollment
44
Locations
3
Primary Endpoint
Number of analgesic consumption
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
September 27, 2019
End Date
February 29, 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Sponsor
Kahramanmaras Sutcu Imam University
Responsible Party
Principal Investigator
Principal Investigator

Gözen Öksüz

Assistant Professor

Kahramanmaras Sutcu Imam University

Eligibility Criteria

Inclusion Criteria

  • 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

Outcomes

Primary Outcomes

Number of analgesic consumption

Time Frame: 24 hour

Acetaminophen and Fentanly

Secondary Outcomes

  • Face, Legs, Activity, Cry and Consolability Score (FLACC)(24 hour)
  • Parent satisfaction scores(24 hour)

Study Sites (3)

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