PECs Block for Pacemaker Insertion in Children

Sponsor
Kasr El Aini Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04931693
Collaborator
(none)
40
1
2
8
5

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
The patient will be randomly assigned to two equal groups. conventional control group(C) (n=20) where20 children will receive IV paracetamol 20 mg / kg . and Pectoral nerves blocks group (P) (n=20) where 20 children will have PECs Block .The patient will be randomly assigned to two equal groups. conventional control group(C) (n=20) where20 children will receive IV paracetamol 20 mg / kg . and Pectoral nerves blocks group (P) (n=20) where 20 children will have PECs Block .
Masking:
Double (Participant, Care Provider)
Masking Description:
An online randomization program (http://www.randomizer.org) will be used to generate random list and to allocate patients into two study groups: Random allocation numbers will be concealed in opaque closed envelops. The patient and investigator performing the block and assessing study outcomes will all be blinded to the study group allocation.
Primary Purpose:
Treatment
Official Title:
Evaluation of Ultrasound Guided Modified Pectoral Nerves Blocks in Transvenous Subpectoral Pacemaker Insertion in Children: Randomized Controlled Trial
Actual Study Start Date :
Dec 20, 2020
Anticipated Primary Completion Date :
Jun 20, 2021
Anticipated Study Completion Date :
Aug 20, 2021

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. Mean Post-operative pain score by The Face, Legs, Activity, Cry, Consolability scale (FLACC) scale. [immediate, 6,12 ,18 and 24 hours after intervention]

      pain score

    Secondary Outcome Measures

    1. Total consumption of opioids. [immediate, 6,12 ,18 and 24 hours after intervention]

      morphine dose

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Year to 9 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kasr Al Ainy Hospital Cairo Egypt 11562

    Sponsors and Collaborators

    • Kasr El Aini Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ahmed Mohamed Mohamed Elhaddad, lecturer, Kasr El Aini Hospital
    ClinicalTrials.gov Identifier:
    NCT04931693
    Other Study ID Numbers:
    • MS-316-2020
    First Posted:
    Jun 18, 2021
    Last Update Posted:
    Jun 18, 2021
    Last Verified:
    Jun 1, 2021
    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
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 18, 2021