PECs Block for Pacemaker Insertion in Children

Phase 4

Completed

• Conditions: Complete Heart Block
• Interventions: Drug: paracetamol; Procedure: modifiedPECs block

• Registration Number: NCT04931693
• Lead Sponsor: Kasr El Aini Hospital

Brief Summary

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

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 Timeline

• Study First Submitted: 2021-06-05
• Study First Submitted QC: 2021-06-17
• Study First Posted: 2021-06-18
• Study Start: 2021-12-20
• Primary Completion: 2022-06-20
• Study Completion: 2022-08-20
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-19
• Last Update Posted: 2022-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control	paracetamol	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.
PECs	modifiedPECs block	Pectoral nerves blocks group (P) (n=20) where 20 children will have PECs Block and atracurium top ups upon request.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Total consumption of opioids.	immediate, 6,12 ,18 and 24 hours after intervention	morphine dose

Trial Locations

Locations (1)

Kasr Al Ainy Hospital; 🇪🇬 Cairo, Egypt