Skip to main content
OpenTrials
Completed

NCT Number: NCT04931693

PECs Block for Pacemaker Insertion in Children

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Complete Heart Block

Age range

1 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Kasr Al Ainy Hospital

Cairo, 11562, Egypt

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Paracetamol

Drug

iv post operative analgesia

Other names: perfalgan

modifiedPECs block

Procedure

sonar guided pectoral nerve block

Other names: PECs 2 block

Primary outcomes

  1. 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

Secondary outcomes

  1. Total consumption of opioids.

    Time frame: immediate, 6,12 ,18 and 24 hours after intervention

    morphine dose

Sponsors and collaborators

Lead sponsor

Kasr El Aini Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 18, 2021
Registry last updated
Oct 20, 2022

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

View the official ClinicalTrials.gov record (opens in a new tab)

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.