Pilot Study of Smartphone -Based AI Assisted Ultrasound Guided Infraorbital Nerve Block in Pediatric Cleft Lip Repair

N/AActive Not RecruitingNCT07232914

Ain Shams University120 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

120

Conditions

Cleft Lip Repair

Interventions

Infraorbital Nerve BlockPROCEDURE

Bilateral infraorbital nerve block smartphone based AI assisted in Arm 1 and landmark based technique in Arm 2

Eligibility

Sex: ALLMin age: 5 MonthsMax age: 18 Months

Medical Language ↔ Plain English

Inclusion Criteria: * Age: 5 -18 months * Weight : 5-15 kilograms * ASA I - II * unilateral cleft lip repair Exclusion Criteria: * less than 5 kilograms weight * Local infection at site of block * Coagulopathy * Parents refusal

Locations (1)

Ain shams university

Cairo, Egypt

Outcomes

Primary Outcomes

Infraorbital Nerve block Success rate measured by intraoperative fentanyl consumption

Time frame: 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

Time frame: Every 6 hours postoperative for first 24 hours

Data from ClinicalTrials.gov

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