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

NCT05778903 | Recruiting

• 1 other identifier: 563605
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Nerve Block; Cleft Palate; Analgesia

Outcome Measures

Primary Outcomes (1)

• Rate of LA spread into the PPF

  Local anesthetic spread to the maxillaris nerve in the pterygopalatine fossa detected by MRI (binary outcome)

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

Secondary Outcomes (8)

• Rate of LA spread to other anatomical areas and structures

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

• Rate of hematoma

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

• Superior-inferior needle angle

  day one - immediately after intervention (peripheral nerve block)

• Anterior-posterior needle angle

  day one - immediately after intervention (peripheral nerve block)

• Needle depth

  day one - immediately after intervention (peripheral nerve block)

Study Arms (2)

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.

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.

Other: Nerve block

Interventions

Nerve block OTHER

Suprazygomatic maxillary nerve block

Landmark guided Suprazygomatic Maxillary Nerve Block landmark; Ultrasound guided Suprazygomatic Maxillary Nerve Block

Eligibility Criteria

• Age: 10 Months - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Oslo University Hospital

Oslo, 0488, Norway

RECRUITING

Related Publications (1)

• 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. 2025 Apr 11:rapm-2025-106439. doi: 10.1136/rapm-2025-106439. Online ahead of print.

  PMID: 40216530 DERIVED

MeSH Terms

Conditions

Cleft Palate; Agnosia

Interventions

Nerve Block

Condition Hierarchy (Ancestors)

Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic Diseases; Mouth Abnormalities; Mouth Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Denervation; Neurosurgical Procedures; Surgical Procedures, Operative

Study Officials

• Axel Sauter, MD PhD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Axel Sauter, MD PhD

CONTACT

93484022; axsa@online.no

Nergis Suleiman, MD

CONTACT

23070000; nergis.nina.suleiman@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 8, 2023
• First Posted: March 21, 2023
• Study Start: June 7, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 3, 2024

Record last verified: 2024-04

Locations

NO (1)