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NCT Number: NCT07232914

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

It's prospective single blinded randomized multi-center trial of 120 infant scheduled for primary unilateral cleft lip repair .

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Cleft Lip Repair

Age range

5 month–18 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain shams university

Cairo, 11751, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Infraorbital Nerve Block

Procedure

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

Primary outcomes

  1. Infraorbital Nerve block Success rate measured by intraoperative fentanyl consumption

    Time frame: Surgical incision was allowed 10 minutes after block injection

  2. 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

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 18, 2025
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.