UnknownNot Applicable

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

Norway20 participantsStarted 2023-06-07

Plain-language 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).

Who can participate

Age range

10 Months – 24 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Rate of LA spread into the PPF

Timeframe: day one - within an hour after intervention (peripheral nerve block)

Trial details

NCT IDNCT05778903

SponsorOslo University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-31

Contact for this trial

Axel Sauter, MD PhD

93484022 axsa@online.no

View on ClinicalTrials.gov More Nerve Block trials