Complete Heart Block
Conditions
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).
Interventions
DRUGparacetamol
iv post operative analgesia
PROCEDUREmodifiedPECs block
sonar guided pectoral nerve block
Sponsors
Kasr El Aini Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
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.
Intervention 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 .
Eligibility
Sex/Gender
ALL
Age
1 Years to 9 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Total consumption of opioids. | immediate, 6,12 ,18 and 24 hours after intervention | morphine dose |
Countries
Egypt
Outcome results
None listed