PECs Block for Pacemaker Insertion in Children

NCT04931693 | Completed Phase 4 DMC

• 1 other identifier: MS-316-2020
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Complete Heart Block

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Total consumption of opioids.

  immediate, 6,12 ,18 and 24 hours after intervention

Study Arms (2)

control

ACTIVE COMPARATOR

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

PECs

ACTIVE COMPARATOR

Pectoral nerves blocks group (P) (n=20) where 20 children will have PECs Block and atracurium top ups upon request.

Procedure: modifiedPECs block

Interventions

paracetamol DRUG

iv post operative analgesia

Also known as: perfalgan

control

modifiedPECs block PROCEDURE

sonar guided pectoral nerve block

Also known as: PECs 2 block

PECs

Eligibility Criteria

• Age: 1 Year - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• congenital or post-operative heart block.

You may not qualify if:

• ⦁ 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

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Kasr Al Ainy Hospital

Cairo, 11562, Egypt

Location

Related 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.

  PMID: 23711654 RESULT

• 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 in children. Heart Rhythm. 2020 Aug;17(8):1346-1353. doi: 10.1016/j.hrthm.2020.03.009. Epub 2020 Mar 20.

  PMID: 32201270 RESULT

MeSH Terms

Interventions

Acetaminophen

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Model Details: 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 .

Study Record Dates

• First Submitted: June 5, 2021
• First Posted: June 18, 2021
• Study Start: December 20, 2021
• Primary Completion: June 20, 2022
• Study Completion: August 20, 2022
• Last Updated: October 20, 2022

Record last verified: 2022-10

Locations

EG (1)