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

Ain Shams University

Status: Active, not recruiting

Conditions: Cleft Lip Repair

Treatments: Procedure: Infraorbital Nerve Block

Study type: Interventional

Funder types: Other

Identifiers

NCT07232914

O6U-ERC-0092

Details and patient eligibility

About

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

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 5 to 18 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Arm 1:Smartphone -Based AI Assisted Ultrasound Guided Infraorbital Nerve Block

Active Comparator group

Description:

Smartphone -Based AI Assisted Ultrasound Guided Infraorbital Nerve Block in pediatric cleft lip repair

Treatment:

Procedure: Infraorbital Nerve Block

Arm 2 : Landmark based technique infraorbital nerve block

Active Comparator group

Description:

Landmark based technique infraorbital nerve block in pediatric cleft lip repair

Treatment:

Procedure: Infraorbital Nerve Block