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

NCT ID: NCT07232914

Last Updated: 2025-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-01

Study Completion Date

2026-02-28

Brief Summary

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

Detailed Description

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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

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Cleft Lip Repair

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Infraorbital Nerve Block

Intervention Type PROCEDURE

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

Arm 2 : Landmark based technique infraorbital nerve block

Landmark based technique infraorbital nerve block in pediatric cleft lip repair

Group Type ACTIVE_COMPARATOR

Infraorbital Nerve Block

Intervention Type PROCEDURE

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

Interventions

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Infraorbital Nerve Block

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

5 Months

Maximum Eligible Age

18 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ain shams university

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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O6U-ERC-0092

Identifier Type: -

Identifier Source: org_study_id

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