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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-07

Study Completion Date

2024-12-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Nerve Block Cleft Palate Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Ultrasound guided Suprazygomatic Maxillary Nerve Block

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.

Group Type ACTIVE_COMPARATOR

Nerve block

Intervention Type OTHER

Suprazygomatic maxillary nerve block

Landmark guided Suprazygomatic Maxillary Nerve Block landmark

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.

Group Type ACTIVE_COMPARATOR

Nerve block

Intervention Type OTHER

Suprazygomatic maxillary nerve block

Interventions

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Nerve block

Suprazygomatic maxillary nerve block

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

10 Months

Maximum Eligible Age

24 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No