NCT07232914

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Ain Shams University · Academic / Other
• Sex: All
• Age: 5 Months – 18 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Cleft Lip Repair

Interventions

Type	Name	Description
PROCEDURE	Infraorbital Nerve Block	Bilateral infraorbital nerve block smartphone based AI assisted in Arm 1 and landmark based technique in Arm 2

Timeline

• Start date: 2025-09-01
• Primary completion: 2026-02-01
• Completion: 2026-02-28
• First posted: 2025-11-18
• Last updated: 2025-11-18

Locations

1 site across 1 country: Egypt