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

Not Applicable

Recruiting

• Conditions: Analgesia; Nerve Block; Cleft Palate
• Interventions: Other: Nerve block

• Registration Number: NCT05778903
• Lead Sponsor: Oslo University Hospital

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-08
• Study First Submitted QC: 2023-03-20
• Study First Posted: 2023-03-21
• Study Start: 2023-06-07
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-02
• Last Update Posted: 2024-04-03
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Landmark guided Suprazygomatic Maxillary Nerve Block landmark	Nerve block	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.
Ultrasound guided Suprazygomatic Maxillary Nerve Block	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.

Primary Outcome Measures

Name	Time	Method
Rate of LA spread into the PPF	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)

Secondary Outcome Measures

Name	Time	Method
Postoperative analgesic consumption	day one and day two	Opioid consumption during the first 24 hours after surgery
MRI time	day one	Time consumption for MRI
Needle depth	day one - immediately after intervention (peripheral nerve block)	Depth of the injection needle
Side effects and adverse events	day one	All side effects or adverse events that might be detected
Rate of hematoma	day one - within an hour after intervention (peripheral nerve block)	Accumulation of blood detected by MRI (binary outcome)
Rate of LA spread to other anatomical areas and structures	day one - within an hour after intervention (peripheral nerve block)	Local anaesthetic spread to orbita, nasal cavity, cranial fossa, infratemporal fossa, or other structures detected by MRI (binary outcome)
Superior-inferior needle angle	day one - immediately after intervention (peripheral nerve block)	Angle of the injection needle meassured in a coronal plane
Anterior-posterior needle angle	day one - immediately after intervention (peripheral nerve block)	Angle of the injection needle meassured in a sagittal plane

Trial Locations

Locations (1)

Oslo University Hospital; 🇳🇴 Oslo, Norway