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It's prospective single blinded randomized multi-center trial of 120 infant scheduled for primary unilateral cleft lip repair .
The patients will be randomly allocated 1:1 into two groups; 60 patients in each group .AI assisted ultrasound - guided infraorbital nerve block and landmark based infraorbital nerve block.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1:Smartphone -Based AI Assisted Ultrasound Guided Infraorbital Nerve Block | Active Comparator | Smartphone -Based AI Assisted Ultrasound Guided Infraorbital Nerve Block in pediatric cleft lip repair |
|
| Arm 2 : Landmark based technique infraorbital nerve block | Active Comparator | Landmark based technique infraorbital nerve block in pediatric cleft lip repair |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infraorbital Nerve Block | Procedure | Bilateral infraorbital nerve block smartphone based AI assisted in Arm 1 and landmark based technique in Arm 2 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Infraorbital Nerve block Success rate measured by intraoperative fentanyl consumption | Surgical incision was allowed 10 minutes after block injection | |
| FlACC pain score | FLACC pain score (Face, Legs, Activity, Cry, and Consolability) Lower score is 0 which means no pain Highest score is 10 which means severe pain | Every 6 hours postoperative for first 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain shams university | Cairo | 11751 | Egypt |
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