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

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).

Study Overview

• Status: Recruiting
• Conditions: Analgesia; Cleft Palate; Nerve Block
• Intervention / Treatment: Other: Nerve block

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Axel Sauter, MD PhD; Phone Number: +47 93484022; Email: axsa@online.no
• Study Contact Backup: Name: Nergis Suleiman, MD; Phone Number: +47 23070000; Email: nergis.nina.suleiman@gmail.com

Study Locations

• Norway
  • Oslo, Norway, 0488
    • Recruiting
    • Oslo University Hospital
    • Contact: Axel R Sauter, PhD; Phone Number: +47 93484022; Email: axsa@online.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 months to 2 years (Child)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Other: Nerve block; Suprazygomatic maxillary nerve block
Active Comparator: 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.	Other: Nerve block; Suprazygomatic maxillary nerve block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	day one - within an hour after intervention (peripheral nerve block)
Rate of hematoma	Accumulation of blood detected by MRI (binary outcome)	day one - within an hour after intervention (peripheral nerve block)
Superior-inferior needle angle	Angle of the injection needle meassured in a coronal plane	day one - immediately after intervention (peripheral nerve block)
Anterior-posterior needle angle	Angle of the injection needle meassured in a sagittal plane	day one - immediately after intervention (peripheral nerve block)
Needle depth	Depth of the injection needle	day one - immediately after intervention (peripheral nerve block)
Side effects and adverse events	All side effects or adverse events that might be detected	day one
Postoperative analgesic consumption	Opioid consumption during the first 24 hours after surgery	day one and day two
MRI time	Time consumption for MRI	day one

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Investigators: Principal Investigator: Axel Sauter, MD PhD, Oslo University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: March 8, 2023
• First Submitted That Met QC Criteria: March 20, 2023
• First Posted (Actual): March 21, 2023

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Stomatognathic Diseases; Mouth Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Jaw Abnormalities; Jaw Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Cleft Palate
• Other Study ID Numbers: 563605

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No