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

University of Oslo (UIO)

Status: Enrolling

Conditions: Cleft Palate; Nerve Block; Analgesia

Treatments: Other: Nerve block

Study type: Interventional

Funder types: Other

Identifiers

NCT05778903

563605

Details and patient eligibility

About

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).

Enrollment: 20 estimated patients

Sex: All

Ages: 10 to 24 months old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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20 participants in 2 patient groups

Ultrasound guided Suprazygomatic Maxillary Nerve Block

Active Comparator group

Description:

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.

Treatment:

Other: Nerve block

Landmark guided Suprazygomatic Maxillary Nerve Block landmark

Active Comparator group

Description:

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.

Treatment:

Other: Nerve block