Analgesic Efficacy of Ultrasound Guided Bilateral Erector Spinae Plane Block in Pediatric.

December 4, 2021 updated by: AHMED ALI GADO, Cairo University

Analgesic Efficacy of Ultrasound Guided Bilateral Erector Spinae Plane Block Versus Fentanyl Infusion in Pediatric Patients Undergoing Cardiac Surgeries. a Randomized Controlled Study.

This randomized, double-blinded, study aims to compare the efficacy of analgesia and any side effects of U/S guided bilateral Erector SpinaePlane block versus non-block t paediatric patients undergoing corrective cardiac surgeries.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Our study will be designed to estimate and compare the analgesic effect of single shotbilatral erector spinae plane block in pediatric patients undergoing corrective cardiac surgeries versus non-block as the control group. Our primary outcome will be the total dose of intraoperative fentanyl boluses.

Randomization will be achieved by using an online random number generator. Patient codes will be placed into sequentially numbered sealed opaque envelopes by a research assistant who is not involved in the study. A medical personnel not involved in patient management will be responsible for opening the envelope and give the instructions contained within each envelope to the anesthesiologist who is expert in doing the ESP block in patients included within the block group. The anesthesia team who managed the patients intraoperatively did not share in recording data for the research. However, another physcian will be responsible for recording the intraoperative data.

Study Type

Interventional

Enrollment (Actual)

98

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Cairo University hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 7 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age:6 months-7 years.
  • ASA, American Society of Anesthesiology, II and III .
  • Patients undergoing cardiac surgeries with midline sternotomy incision.

Exclusion Criteria:

  • Patients whose parents or legal guardians refusing to participate.
  • Preoperative mechanical ventilation.
  • Preoperative inotropic drug infusion.
  • Known or suspected coagulopathy.
  • Any congenital anomalies of the sacrum/the vertebral column or any infection at the site of injection.
  • Known or suspected allergy to any of the studied drugs.
  • Elevated liver enzymes more than the normal values.
  • Renal function impairment (Creatinine value more than 1.2 mg/dl or BUN more than 20mg/dl).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: bilateral erector spinae plane block
The patient WILL receive bilateral erector spinae plane block.
Procedure: bilateral erector spinae block

An ultrasound transducer will be placed in a longitudinal orientation 3 cm lateral to the T3 spinous process corresponding to the T2 transverse process.

Three muscles; trapezius , rhomboids major , and erector spinae will be identified superior to the hyperechoic transverse process.

Using in-plane approach a 25 G needle will be inserted in caudal-cephalad direction, until the tip is deep to erector spinae muscle.

Correct needle tip location will be confirmed by injecting 3 mL of saline and visualizing the linear LA spread in the fascial plane between the erector spinae muscle and the transverse process..

0.4 ml/kg (1:1 solution of bupivacaine 0.25% and lidocaine 1%) will be injected and visualizing the linear LA spread in the fascial plane between the erector spinae muscle andthe transverse process12.
No Intervention: NO BLOCK
The patient will not receive Erector spinae plane block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The total dose of intraoperative fentanyl boluses in microgram.
Time Frame: 3 months
The total dose of intraoperative fentanyl boluses in microgram
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain assessment at postoperatively by FLACC score
Time Frame: 3 months
Pain assessment postoperatively by FLACC score
3 months
Total consumption of morphine during the first 24 hours postoperatively.
Time Frame: 3 monts
Total consumption of morphine during the first 24 hours postoperatively
3 monts
extubation time
Time Frame: 3 months
time from finishing skin incision suturing and cessation of anesthesia to successful removal of endotracheal tube.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 20, 2020

Primary Completion (Actual)

August 5, 2021

Study Completion (Actual)

August 15, 2021

Study Registration Dates

First Submitted

June 25, 2020

First Submitted That Met QC Criteria

June 29, 2020

First Posted (Actual)

June 30, 2020

Study Record Updates

Last Update Posted (Actual)

December 21, 2021

Last Update Submitted That Met QC Criteria

December 4, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • N159-2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The patients data are confidential

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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