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

Oslo University Hospital20 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Nerve Block Cleft Palate Analgesia

Interventions

Nerve blockOTHER

Suprazygomatic maxillary nerve block

Eligibility

Sex: ALLMin age: 10 MonthsMax age: 24 Months

Medical Language ↔ Plain English

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.

Locations (1)

Oslo University Hospital

Oslo, Norway

RECRUITING

Outcomes

Primary Outcomes

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)

Secondary Outcomes

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

Central Contacts

Axel Sauter, MD PhD

CONTACT

93484022 axsa@online.no

Nergis Suleiman, MD

CONTACT

23070000 nergis.nina.suleiman@gmail.com

Data from ClinicalTrials.gov

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