PECs Block for Pacemaker Insertion in Children

October 19, 2022 updated by: Ahmed Mohamed Mohamed Elhaddad, Kasr El Aini Hospital

Evaluation of Ultrasound Guided Modified Pectoral Nerves Blocks in Transvenous Subpectoral Pacemaker Insertion in Children: Randomized Controlled Trial

Evaluation of Ultrasound Guided Modified Pectoral Nerves Blocks in Transvenous Subpectoral pacemaker insertion in Children: Randomized Controlled Trial

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

BACKGROUND Pectoral nerve blocks (PECs) can reduce intraprocedural anesthetic requirements and postoperative pain. Little is known about the utility of PECs in reducing pain and narcotic use after pacemaker (PM)placement in children. OBJECTIVE The purpose of this study was to determine whether PECs can decrease postoperative pain and opioid use after PM placement in children.

METHODS A single-center controlled trial of pediatric patients undergoing transvenous PM placement between 2020 and 2021 will be performed. Demographics, procedural variables, postoperative pain, and postoperative opioid usage will be compared between patients who undergone PECs and those who undergone conventional anesthetic (Control).

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 4

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, 11562
        • Kasr Al Ainy Hospital

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

1 year to 9 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • congenital or post-operative heart block.

Exclusion Criteria:

  • ⦁ Redo patient

    • History of allergic reactions to local anesthetics.
    • Bleeding disorders with International Normalization Ratio( INR) > 1.5 and/or platelets < 50 000.
    • Rash or signs of infection at the injection site.
    • Emergency procedure

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: control
conventional control group(C) (n=20) where20 children will receive IV paracetamol 20 mg / kg and atracurium top ups at a dose of 0.1mg/kg. every 30 minutes.
Drug: paracetamol
iv post operative analgesia
Other Names:
  • perfalgan
Active Comparator: PECs
Pectoral nerves blocks group (P) (n=20) where 20 children will have PECs Block and atracurium top ups upon request.
Procedure: modifiedPECs block
sonar guided pectoral nerve block
Other Names:
  • PECs 2 block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Post-operative pain score by The Face, Legs, Activity, Cry, Consolability scale (FLACC) scale.
Time Frame: immediate, 6,12 ,18 and 24 hours after intervention
pain score
immediate, 6,12 ,18 and 24 hours after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total consumption of opioids.
Time Frame: immediate, 6,12 ,18 and 24 hours after intervention
morphine dose
immediate, 6,12 ,18 and 24 hours after intervention

Collaborators and Investigators

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

Sponsor

Kasr El Aini Hospital

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)

December 20, 2021

Primary Completion (Actual)

June 20, 2022

Study Completion (Actual)

August 20, 2022

Study Registration Dates

First Submitted

June 5, 2021

First Submitted That Met QC Criteria

June 17, 2021

First Posted (Actual)

June 18, 2021

Study Record Updates

Last Update Posted (Actual)

October 20, 2022

Last Update Submitted That Met QC Criteria

October 19, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MS-316-2020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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