Cleft Lip RepairNCT07232914
Pilot Study of Smartphone -Based AI Assisted Ultrasound Guided Infraorbital Nerve Block in Pediatric Cleft Lip Repair
A study testing Infraorbital Nerve Block in people with Cleft Lip Repair, run by Ain Shams University at 1 site in Egypt.
Trial summary
It's prospective single blinded randomized multi-center trial of 120 infant scheduled for primary unilateral cleft lip repair . Read more about this study
- Who is it for?
- Ages 5 to 18 months
- Conditions the study is for
- Cleft Lip Repair
- What is being tested?
- Infraorbital Nerve Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2025to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age: 5 -18 months
- Weight : 5-15 kilograms
- ASA I - II
- unilateral cleft lip repair
Who cannot join
- less than 5 kilograms weight
- Local infection at site of block
- Coagulopathy
- Parents refusal
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
It's prospective single blinded randomized multi-center trial of 120 infant scheduled for primary unilateral cleft lip repair .
Read the 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
- Being tested
- Infraorbital Nerve Block
- Keywords
- AI Assisted nerve block, Cleft lip repair
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infraorbital Nerve BlockProcedure or surgery
Bilateral infraorbital nerve block smartphone based AI assisted in Arm 1 and landmark based technique in Arm 2
| Study group | Role | What they receive |
|---|---|---|
| Arm 1:Smartphone -Based AI Assisted Ultrasound Guided Infraorbital Nerve Block | Active comparator | Smartphone -Based AI Assisted Ultrasound Guided Infraorbital Nerve Block in pediatric cleft lip repair Receives: Procedure: Infraorbital Nerve Block |
| Arm 2 : Landmark based technique infraorbital nerve block | Active comparator | Landmark based technique infraorbital nerve block in pediatric cleft lip repair Receives: Procedure: Infraorbital Nerve Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infraorbital Nerve block Success rate measured by intraoperative fentanyl consumption
Measured: Surgical incision was allowed 10 minutes after block injection
FlACC pain score
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
Measured: Every 6 hours postoperative for first 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start1 Sep 2025
- Primary completionFeb 2026 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cleft Lip RepairStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07232914
- Sponsor's protocol ID
- O6U-ERC-0092
- Status last verified
- Sep 2025
- First submitted
- 13 Nov 2025
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07232914
- Acronym / sponsor ID
- O6U-ERC-0092
- Conditions
- Cleft Lip Repair
- Keywords
- AI Assisted nerve block, Cleft lip repair
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 18 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1:Smartphone -Based AI Assisted Ultrasound Guided Infraorbital Nerve Block | Active comparator | Procedure: Infraorbital Nerve BlockSmartphone -Based AI Assisted Ultrasound Guided Infraorbital Nerve Block in pediatric cleft lip repair |
| Arm 2 : Landmark based technique infraorbital nerve block | Active comparator | Procedure: Infraorbital Nerve BlockLandmark based technique infraorbital nerve block in pediatric cleft lip repair |
Who may qualify
- Ages
- 5 to 18 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age: 5 -18 months
- Weight : 5-15 kilograms
- ASA I - II
- unilateral cleft lip repair
Key exclusion criteria (4 listed)
- less than 5 kilograms weight
- Local infection at site of block
- Coagulopathy
- Parents refusal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infraorbital Nerve BlockBilateral infraorbital nerve block smartphone based AI assisted in Arm 1 and landmark based technique in Arm 2 | Procedure or surgery | Arm 1:Smartphone -Based AI Assisted Ultrasound Guided Infraorbital Nerve Block, Arm 2 : Landmark based technique infraorbital nerve block |
Primary outcome
Infraorbital Nerve block Success rate measured by intraoperative fentanyl consumption
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infraorbital Nerve Block in people with Cleft Lip Repair, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infraorbital Nerve block Success rate measured by intraoperative fentanyl consumption (time frame: Surgical incision was allowed 10 minutes after block injection). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.