PECs Block for Pacemaker Insertion in Children

Complete Heart Block Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04931693
• Other study ID #: MS-316-2020
• Status: Completed
• Phase: Phase 4
• Start date: December 20, 2021
• Est. completion date: August 20, 2022

Study information

• Verified date: October 2022
• Source: Kasr El Aini Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 20, 2022
• Est. primary completion date: June 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 9 Years

Eligibility

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

Related Conditions & MeSH terms

• Complete Heart Block
• Heart Block

Intervention

Drug:
• paracetamol
iv post operative analgesia

Procedure:
• modifiedPECs block
sonar guided pectoral nerve block

Locations

Country	Name	City	State
Egypt	Kasr Al Ainy Hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Kasr El Aini Hospital

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

Anderson R, Harukuni I, Sera V. Anesthetic considerations for electrophysiologic procedures. Anesthesiol Clin. 2013 Jun;31(2):479-89. doi: 10.1016/j.anclin.2013.01.005. Epub 2013 Feb 23. Review. — View Citation

Yang JK, Char DS, Motonaga KS, Navaratnam M, Dubin AM, Trela A, Hanisch DG, McFadyen G, Chubb H, Goodyer WR, Ceresnak SR. Pectoral nerve blocks decrease postoperative pain and opioid use after pacemaker or implantable cardioverter-defibrillator placement — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Post-operative pain score by The Face, Legs, Activity, Cry, Consolability scale (FLACC) scale.	pain score	immediate, 6,12 ,18 and 24 hours after intervention
Secondary	Total consumption of opioids.	morphine dose	immediate, 6,12 ,18 and 24 hours after intervention