A Pilot Study of Smartphone -Based AI Assisted Ultrasound Guided Infraorbital Nerve Block in Pediatric Cleft Lip Repair : A Novel Low-cost Solution in Resource Limited Settings
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Ain Shams University
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Infraorbital Nerve block Success rate measured by intraoperative fentanyl consumption
Study Overview
Brief Summary
It's prospective single blinded randomized multi-center trial of 120 infant scheduled for primary unilateral cleft lip repair .
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 5 Months to 18 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Arm 1:Smartphone -Based AI Assisted Ultrasound Guided Infraorbital Nerve Block
Smartphone -Based AI Assisted Ultrasound Guided Infraorbital Nerve Block in pediatric cleft lip repair
Intervention: Infraorbital Nerve Block (Procedure)
Arm 2 : Landmark based technique infraorbital nerve block
Landmark based technique infraorbital nerve block in pediatric cleft lip repair
Intervention: Infraorbital Nerve Block (Procedure)
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
Time Frame: Every 6 hours postoperative for first 24 hours
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
Secondary Outcomes
No secondary outcomes reported