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

Analgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05778903
• Other study ID #: 563605
• Status: Recruiting
• Phase: N/A
• Start date: June 7, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: Oslo University Hospital
• Contact: Axel Sauter, MD PhD
• Phone: 93484022
• Email: axsa[@]online.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Months to 24 Months

Eligibility

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.

Related Conditions & MeSH terms

• Analgesia
• Cleft Palate
• Nerve Block

Intervention

Other:
• Nerve block
Suprazygomatic maxillary nerve block

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	Rate of hematoma	Accumulation of blood detected by MRI (binary outcome)	day one - within an hour after intervention (peripheral nerve block)
Secondary	Superior-inferior needle angle	Angle of the injection needle meassured in a coronal plane	day one - immediately after intervention (peripheral nerve block)
Secondary	Anterior-posterior needle angle	Angle of the injection needle meassured in a sagittal plane	day one - immediately after intervention (peripheral nerve block)
Secondary	Needle depth	Depth of the injection needle	day one - immediately after intervention (peripheral nerve block)
Secondary	Side effects and adverse events	All side effects or adverse events that might be detected	day one
Secondary	Postoperative analgesic consumption	Opioid consumption during the first 24 hours after surgery	day one and day two
Secondary	MRI time	Time consumption for MRI	day one