Cleft Lip Repair
Conditions
Keywords
AI Assisted nerve block, Cleft lip repair
Brief summary
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.
Interventions
PROCEDUREInfraorbital Nerve Block
Bilateral infraorbital nerve block smartphone based AI assisted in Arm 1 and landmark based technique in Arm 2
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Months to 18 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Infraorbital Nerve block Success rate measured by intraoperative fentanyl consumption | Surgical incision was allowed 10 minutes after block injection | — |
| FlACC pain score | 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 |
Countries
Egypt
Outcome results
None listed