Nerve BlockNCT05778903
Maxillary Nerve Blocks in Children - An MRI Study of the Suprazygomatic Approach
A study testing Nerve block in people with Nerve Block and Cleft Palate, run by Oslo University Hospital at 1 site in Norway.
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… Read more about this study
- Who is it for?
- Ages 10 to 24 months
- Conditions the study is for
- Nerve Block, Cleft Palate, Analgesia
- What is being tested?
- Nerve block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNorway
- Study dates
- 7 Jun 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Oslo University Hospital
Oslo, 0488
Axel R Sauter, PhD, 93484022 ext. +47, axsa@online.no
About this study
Official title: Maxillary Nerve Blocks in Children - An MRI Study of the Suprazygomatic
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).
- Conditions
- Nerve Block, Cleft Palate, Analgesia
- Being tested
- Nerve block
- Medical subject headings
- Cleft Palate, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nerve blockOther
Suprazygomatic maxillary nerve block
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound guided Suprazygomatic Maxillary Nerve Block | Active comparator | 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. Receives: Other: Nerve block |
| Landmark guided Suprazygomatic Maxillary Nerve Block landmark | Active comparator | 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. Receives: Other: Nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of LA spread into the PPF
Local anesthetic spread to the maxillaris nerve in the pterygopalatine fossa detected by MRI (binary outcome)
Measured: day one - within an hour after intervention (peripheral nerve block)
Secondary outcomes (8)
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)
Measured: day one - within an hour after intervention (peripheral nerve block)
Rate of hematoma
Accumulation of blood detected by MRI (binary outcome)
Measured: day one - within an hour after intervention (peripheral nerve block)
Superior-inferior needle angle
Angle of the injection needle meassured in a coronal plane
Measured: day one - immediately after intervention (peripheral nerve block)
Anterior-posterior needle angle
Angle of the injection needle meassured in a sagittal plane
Measured: day one - immediately after intervention (peripheral nerve block)
Needle depth
Depth of the injection needle
Measured: day one - immediately after intervention (peripheral nerve block)
Side effects and adverse events
All side effects or adverse events that might be detected
Measured: day one
Postoperative analgesic consumption
Opioid consumption during the first 24 hours after surgery
Measured: day one and day two
MRI time
Time consumption for MRI
Measured: day one
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2023
- Study start7 Jun 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nerve BlockStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Axel R. Sauter, Oslo University Hospital
- Investigators
- Axel Sauter, MD PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05778903
- Sponsor's protocol ID
- 563605
- Status last verified
- Apr 2024
- First submitted
- 8 Mar 2023
- Last updated
- 3 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Suleiman NN, Lien I, Akhavi MS, Impieri D, Ullensvang K, Moen JM, Lindholm P, Langesaeter E, Sauter AR. Ultrasound guidance does not improve local anesthetic distribution in suprazygomatic maxillary nerve blocks in pediatric patients: a clinical, randomized, controlled, observer-blinded, crossover MRI trial. Reg Anesth Pain Med. 2026 Jun 5;51(6):700-706. doi: 10.1136/rapm-2025-106439.
PubMed 40216530
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maxillary Nerve Blocks in Children - An MRI Study of the Suprazygomatic
- ClinicalTrials.gov ID
- NCT05778903
- Acronym / sponsor ID
- 563605
- Conditions
- Nerve Block, Cleft Palate, Analgesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 7 Jun 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 21 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound guided Suprazygomatic Maxillary Nerve Block | Active comparator | Other: Nerve blockAn 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. |
| Landmark guided Suprazygomatic Maxillary Nerve Block landmark | Active comparator | Other: Nerve blockA 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. |
Who may qualify
- Ages
- 10 to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nerve blockSuprazygomatic maxillary nerve block | Other | Landmark guided Suprazygomatic Maxillary Nerve Block landmark, Ultrasound guided Suprazygomatic Maxillary Nerve Block |
Primary outcome
Rate of LA spread into the PPF
Time frame: day one - within an hour after intervention (peripheral nerve block)
Local anesthetic spread to the maxillaris nerve in the pterygopalatine fossa detected by MRI (binary outcome)
8 secondary outcomes
Rate of LA spread to other anatomical areas and structures
Time frame: day one - within an hour after intervention (peripheral nerve block)
Rate of hematoma
Time frame: day one - within an hour after intervention (peripheral nerve block)
Superior-inferior needle angle
Time frame: day one - immediately after intervention (peripheral nerve block)
Anterior-posterior needle angle
Time frame: day one - immediately after intervention (peripheral nerve block)
Needle depth
Time frame: day one - immediately after intervention (peripheral nerve block)
Side effects and adverse events
Time frame: day one
Postoperative analgesic consumption
Time frame: day one and day two
MRI time
Time frame: day one
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
- Derived from this study: PubMed 40216530Suleiman NN, Lien I, Akhavi MS, Impieri D, Ullensvang K, Moen JM, Lindholm P, Langesaeter E, Sauter AR. Ultrasound guidance does not improve local anesthetic distribution in suprazygomatic maxillary nerve blocks in pediatric patients: a clinical, randomized, controlled, observer-blinded, crossover MRI trial. Reg Anesth Pain Med. 2026 Jun 5;51(6):700-706. doi: 10.1136/rapm-2025-106439.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Axel Sauter, MD PhD principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nerve block in people with Nerve Block and Cleft Palate, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Axel Sauter, MD PhD (93484022 ext. +47, axsa@online.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of LA spread into the PPF (time frame: day one - within an hour after intervention (peripheral nerve block)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05778903, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2024.