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Evaluation of Ultrasound Guided Modified Pectoral Nerves Blocks in Transvenous Subpectoral pacemaker insertion in Children: Randomized Controlled Trial
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| PECs | Active Comparator | Pectoral nerves blocks group (P) (n=20) where 20 children will have PECs Block and atracurium top ups upon request. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| paracetamol | Drug | iv post operative analgesia |
|
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Total consumption of opioids. | morphine dose | immediate, 6,12 ,18 and 24 hours after intervention |
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Inclusion Criteria:
Exclusion Criteria:
⦁ Redo patient
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kasr Al Ainy Hospital | Cairo | 11562 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23711654 | Result | 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. | |
| 32201270 | 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. |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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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 .
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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.
| modifiedPECs block | Procedure | sonar guided pectoral nerve block |
|
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| 42254071 | Derived | Zheng T, Zhong Y, Zhang L, Cheng X, Hu J, Huang X, Zhan B. Ultrasound-Guided Pectoral Nerve Block for Cardiac Implantable Electronic Device Implantation: A Prospective Randomized Controlled Trial of Postprocedural Analgesic Benefit in an Asian Population. Anesthesiol Res Pract. 2026 Jun 4;2026:8742805. doi: 10.1155/anrp/8742805. eCollection 2026. |
| Aniline Compounds |
| D000588 | Amines |