Maxillary Nerve Blocks in Children - An MRI Study of the Suprazygomatic Approach

Study Overview
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Brief Summary
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Ultrasound-guided suprazygomatic maxillary nerve block (SMNB) will be performed in paediatric patients with or without the aid of ultrasound guidance. Magnetic resonance imaging (MRI) is used to visualize the spread of the local anaesthetic (LA) spread after suprazygomatic injection and to verify LA contact with the maxillary nerve in the pterygopalatine fossa (PPF).

Official Title
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Maxillary Nerve Blocks in Children - An MRI Study of the Suprazygomatic

Conditions
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Nerve Block, Cleft Palate, Analgesia

Intervention / Treatment
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* Other: Nerve block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Paediatric patients scheduled for cleft palate (CP) surgery with SMNB as part of their perioperative pain treatment American Society of Anesthesiologists physical status 1 - 2 Age 10 to 24 months Given informed written consent by legal guardian Exclusion Criteria: American Society of Anesthesiologists physical status > 2 Patients with cranial deformation Patients with concomitant medical treatments or medical conditions interfering with peripheral nerve block treatment Patients with concomitant medical treatments or medical conditions interfering with MRI Patients that are allergic to bupivacaine or other local anaesthetic agents.

Ages Eligible for Study
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Minimum Age: 10 Months
Maximum Age: 24 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ultrasound guided Suprazygomatic Maxillary Nerve Block<br>An ultasound guided SMNB is admitted on one half of the patients face (left or right) according to randomiced allocation. 0.15 ml/kg of bupivacaine 0.25 mg/ml with epinephrin 5 mcg/ml is injected. | Other: Nerve block<br>* Suprazygomatic maxillary nerve block<br>|
| Active Comparator: Landmark guided Suprazygomatic Maxillary Nerve Block landmark<br>A langmark guided SMNB is admitted on the other half of the patients face (left or right) according to randomiced allocation. 0.15 ml/kg of bupivacaine 0.25 mg/ml with epinephrin 5 mcg/ml is injected. | Other: Nerve block<br>* Suprazygomatic maxillary nerve block<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of LA spread into the PPF | Local anesthetic spread to the maxillaris nerve in the pterygopalatine fossa detected by MRI (binary outcome) | day one - within an hour after intervention (peripheral nerve block) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative analgesic consumption | Opioid consumption during the first 24 hours after surgery | day one and day two | 
| MRI time | Time consumption for MRI | day one | 
| Rate of LA spread to other anatomical areas and structures | Local anaesthetic spread to orbita, nasal cavity, cranial fossa, infratemporal fossa, or other structures detected by MRI (binary outcome) | day one - within an hour after intervention (peripheral nerve block) | 
| Rate of hematoma | Accumulation of blood detected by MRI (binary outcome) | day one - within an hour after intervention (peripheral nerve block) | 
| Superior-inferior needle angle | Angle of the injection needle meassured in a coronal plane | day one - immediately after intervention (peripheral nerve block) | 
| Anterior-posterior needle angle | Angle of the injection needle meassured in a sagittal plane | day one - immediately after intervention (peripheral nerve block) | 
| Needle depth | Depth of the injection needle | day one - immediately after intervention (peripheral nerve block) | 
| Side effects and adverse events | All side effects or adverse events that might be detected | day one |