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Clinical Trials/NCT04931693
NCT04931693
Completed
Phase 4

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

Kasr El Aini Hospital1 site in 1 country40 target enrollmentDecember 20, 2021

Overview

Phase
Phase 4
Intervention
paracetamol
Conditions
Complete Heart Block
Sponsor
Kasr El Aini Hospital
Enrollment
40
Locations
1
Primary Endpoint
Mean Post-operative pain score by The Face, Legs, Activity, Cry, Consolability scale (FLACC) scale.
Status
Completed
Last Updated
3 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
December 20, 2021
End Date
August 20, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Kasr El Aini Hospital
Responsible Party
Principal Investigator
Principal Investigator

Ahmed Mohamed Mohamed Elhaddad

lecturer

Kasr El Aini Hospital

Eligibility Criteria

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
  • Rash or signs of infection at the injection site.
  • Emergency procedure

Arms & Interventions

control

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.

Intervention: paracetamol

PECs

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

Intervention: modifiedPECs block

Outcomes

Primary Outcomes

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

  • Total consumption of opioids.(immediate, 6,12 ,18 and 24 hours after intervention)

Study Sites (1)

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