Analgesia, Cleft Palate, Nerve Block
Conditions
Brief summary
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).
Interventions
OTHERNerve block
Suprazygomatic maxillary nerve block
Sponsors
Oslo University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
10 Months to 24 Months
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of LA spread into the PPF | day one - within an hour after intervention (peripheral nerve block) | Local anesthetic spread to the maxillaris nerve in the pterygopalatine fossa detected by MRI (binary outcome) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of hematoma | day one - within an hour after intervention (peripheral nerve block) | Accumulation of blood detected by MRI (binary outcome) |
| Superior-inferior needle angle | day one - immediately after intervention (peripheral nerve block) | Angle of the injection needle meassured in a coronal plane |
| Anterior-posterior needle angle | day one - immediately after intervention (peripheral nerve block) | Angle of the injection needle meassured in a sagittal plane |
| Rate of LA spread to other anatomical areas and structures | day one - within an hour after intervention (peripheral nerve block) | Local anaesthetic spread to orbita, nasal cavity, cranial fossa, infratemporal fossa, or other structures detected by MRI (binary outcome) |
| Side effects and adverse events | day one | All side effects or adverse events that might be detected |
| Postoperative analgesic consumption | day one and day two | Opioid consumption during the first 24 hours after surgery |
| MRI time | day one | Time consumption for MRI |
| Needle depth | day one - immediately after intervention (peripheral nerve block) | Depth of the injection needle |
Countries
Norway
Contacts
Primary ContactAxel Sauter, MD PhD
Backup ContactNergis Suleiman, MD
Outcome results
None listed