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

November 16, 2025 updated by: Ain Shams University

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11751
        • Ain Shams University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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
Procedure: Infraorbital Nerve Block
Bilateral infraorbital nerve block smartphone based AI assisted in Arm 1 and landmark based technique in Arm 2
Active Comparator: Arm 2 : Landmark based technique infraorbital nerve block
Landmark based technique infraorbital nerve block in pediatric cleft lip repair
Procedure: Infraorbital Nerve Block
Bilateral infraorbital nerve block smartphone based AI assisted in Arm 1 and landmark based technique in Arm 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infraorbital Nerve block Success rate measured by intraoperative fentanyl consumption
Time Frame: Surgical incision was allowed 10 minutes after block injection
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
Every 6 hours postoperative for first 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2025

Primary Completion (Estimated)

February 1, 2026

Study Completion (Estimated)

February 28, 2026

Study Registration Dates

First Submitted

November 13, 2025

First Submitted That Met QC Criteria

November 16, 2025

First Posted (Actual)

November 18, 2025

Study Record Updates

Last Update Posted (Actual)

November 18, 2025

Last Update Submitted That Met QC Criteria

November 16, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • O6U-ERC-0092

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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