PECs Block for Pacemaker Insertion in Children

Kasr El Aini Hospital

Status and phase: Completed; Phase 4

Conditions: Complete Heart Block

Treatments: Drug: paracetamol; Procedure: modifiedPECs block

Study type: Interventional

Funder types: Other

Identifiers

NCT04931693

MS-316-2020

Details and patient eligibility

About

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

Full 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).

Enrollment: 40 patients

Sex: All

Ages: 1 to 9 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

control

Active Comparator group

Description:

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.

Treatment:

Drug: paracetamol

PECs

Active Comparator group

Description:

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

Treatment:

Procedure: modifiedPECs block