Back to resultsPECs Block for Pacemaker Insertion in Children
Primary Purpose
Complete Heart Block
Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
paracetamol
modifiedPECs block
Sponsored by
About this trial
This is an interventional treatment trial for Complete Heart Block
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 < 50 000.
- Rash or signs of infection at the injection site.
- Emergency procedure
Sites / Locations
- Kasr Al Ainy Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
control
PECs
Arm 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.
Pectoral nerves blocks group (P) (n=20) where 20 children will have PECs Block and atracurium top ups upon request.
Outcomes
Primary Outcome Measures
Mean Post-operative pain score by The Face, Legs, Activity, Cry, Consolability scale (FLACC) scale.
pain score
Secondary Outcome Measures
Total consumption of opioids.
morphine dose
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04931693
Brief Title
PECs Block for Pacemaker Insertion in Children
Official Title
Evaluation of Ultrasound Guided Modified Pectoral Nerves Blocks in Transvenous Subpectoral Pacemaker Insertion in Children: Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
December 20, 2021 (Actual)
Primary Completion Date
June 20, 2022 (Actual)
Study Completion Date
August 20, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kasr El Aini Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complete Heart Block
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
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 .
Masking
ParticipantCare Provider
Masking Description
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.
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
control
Arm Type
Active Comparator
Arm 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.
Arm Title
PECs
Arm Type
Active Comparator
Arm Description
Pectoral nerves blocks group (P) (n=20) where 20 children will have PECs Block and atracurium top ups upon request.
Intervention Type
Drug
Intervention Name(s)
paracetamol
Other Intervention Name(s)
perfalgan
Intervention Description
iv post operative analgesia
Intervention Type
Procedure
Intervention Name(s)
modifiedPECs block
Other Intervention Name(s)
PECs 2 block
Intervention Description
sonar guided pectoral nerve block
Primary Outcome Measure Information:
Title
Mean Post-operative pain score by The Face, Legs, Activity, Cry, Consolability scale (FLACC) scale.
Description
pain score
Time Frame
immediate, 6,12 ,18 and 24 hours after intervention
Secondary Outcome Measure Information:
Title
Total consumption of opioids.
Description
morphine dose
Time Frame
immediate, 6,12 ,18 and 24 hours after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
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 < 50 000.
Rash or signs of infection at the injection site.
Emergency procedure
Facility Information:
Facility Name
Kasr Al Ainy Hospital
City
Cairo
ZIP/Postal Code
11562
Country
Egypt
12. IPD Sharing Statement
Citations:
PubMed Identifier
23711654
Citation
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.
Results Reference
result
PubMed Identifier
32201270
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 in children. Heart Rhythm. 2020 Aug;17(8):1346-1353. doi: 10.1016/j.hrthm.2020.03.009. Epub 2020 Mar 20.
Results Reference
result
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PECs Block for Pacemaker Insertion in Children
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