An interventional study of Nerve block in Nerve Block, Cleft Palate and Analgesia, sponsored by Oslo University Hospital. Recruiting at 1 site in Norway. Open to participants aged 10 Months to 24 Months. Per ClinicalTrials.gov, last updated 2024-04-03.
Sponsored by Oslo University Hospital · Not applicable, Interventional, and Treatment
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).
131 studies on the registry are indexed under Cleft Palate; 36 are open to participants now.
This study's planned enrollment of 20 is below the median of 40 across 85 interventional studies indexed under Cleft Palate.
Browse Cleft Palate studies →Oslo University Hospital is the lead sponsor of 810 studies on the registry; 148 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
Suprazygomatic maxillary nerve block
Rate of LA spread into the PPF
Local anesthetic spread to the maxillaris nerve in the pterygopalatine fossa detected by MRI (binary outcome)
Time frame: day one - within an hour after intervention (peripheral nerve block)
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)
Time frame: day one - within an hour after intervention (peripheral nerve block)
Rate of hematoma
Accumulation of blood detected by MRI (binary outcome)
Time frame: day one - within an hour after intervention (peripheral nerve block)
Superior-inferior needle angle
Angle of the injection needle meassured in a coronal plane
Time frame: day one - immediately after intervention (peripheral nerve block)
Anterior-posterior needle angle
Angle of the injection needle meassured in a sagittal plane
Time frame: day one - immediately after intervention (peripheral nerve block)
Needle depth
Depth of the injection needle
Time frame: day one - immediately after intervention (peripheral nerve block)
Side effects and adverse events
All side effects or adverse events that might be detected
Time frame: day one
Postoperative analgesic consumption
Opioid consumption during the first 24 hours after surgery
Time frame: day one and day two
MRI time
Time consumption for MRI
Time frame: day one
Plan to share: Undecided
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Oslo University Hospital