Back to resultsMaxillary Nerve Blocks in Children - An MRI Study of the Suprazygomatic Approach
Primary Purpose
Nerve Block, Cleft Palate, Analgesia
Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Nerve block
Sponsored by
About this trial
This is an interventional treatment trial for Nerve Block
Eligibility Criteria
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.
Sites / Locations
- Oslo University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Ultrasound guided Suprazygomatic Maxillary Nerve Block
Landmark guided Suprazygomatic Maxillary Nerve Block landmark
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Rate of LA spread into the PPF
Local anesthetic spread to the maxillaris nerve in the pterygopalatine fossa detected by MRI (binary outcome)
Secondary Outcome Measures
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)
Rate of hematoma
Accumulation of blood detected by MRI (binary outcome)
Superior-inferior needle angle
Angle of the injection needle meassured in a coronal plane
Anterior-posterior needle angle
Angle of the injection needle meassured in a sagittal plane
Needle depth
Depth of the injection needle
Side effects and adverse events
All side effects or adverse events that might be detected
Postoperative analgesic consumption
Opioid consumption during the first 24 hours after surgery
MRI time
Time consumption for MRI
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05778903
Brief Title
Maxillary Nerve Blocks in Children - An MRI Study of the Suprazygomatic Approach
Official Title
Maxillary Nerve Blocks in Children - An MRI Study of the Suprazygomatic
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 7, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nerve Block, Cleft Palate, Analgesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ultrasound guided Suprazygomatic Maxillary Nerve Block
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Landmark guided Suprazygomatic Maxillary Nerve Block landmark
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Nerve block
Intervention Description
Suprazygomatic maxillary nerve block
Primary Outcome Measure Information:
Title
Rate of LA spread into the PPF
Description
Local anesthetic spread to the maxillaris nerve in the pterygopalatine fossa detected by MRI (binary outcome)
Time Frame
day one - within an hour after intervention (peripheral nerve block)
Secondary Outcome Measure Information:
Title
Rate of LA spread to other anatomical areas and structures
Description
Local anaesthetic spread to orbita, nasal cavity, cranial fossa, infratemporal fossa, or other structures detected by MRI (binary outcome)
Time Frame
day one - within an hour after intervention (peripheral nerve block)
Title
Rate of hematoma
Description
Accumulation of blood detected by MRI (binary outcome)
Time Frame
day one - within an hour after intervention (peripheral nerve block)
Title
Superior-inferior needle angle
Description
Angle of the injection needle meassured in a coronal plane
Time Frame
day one - immediately after intervention (peripheral nerve block)
Title
Anterior-posterior needle angle
Description
Angle of the injection needle meassured in a sagittal plane
Time Frame
day one - immediately after intervention (peripheral nerve block)
Title
Needle depth
Description
Depth of the injection needle
Time Frame
day one - immediately after intervention (peripheral nerve block)
Title
Side effects and adverse events
Description
All side effects or adverse events that might be detected
Time Frame
day one
Title
Postoperative analgesic consumption
Description
Opioid consumption during the first 24 hours after surgery
Time Frame
day one and day two
Title
MRI time
Description
Time consumption for MRI
Time Frame
day one
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Months
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Axel Sauter, MD PhD
Phone
93484022
Ext
+47
Email
axsa@online.no
First Name & Middle Initial & Last Name or Official Title & Degree
Nergis Suleiman, MD
Phone
23070000
Ext
+47
Email
nergis.nina.suleiman@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Axel Sauter, MD PhD
Organizational Affiliation
Oslo University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oslo University Hospital
City
Oslo
ZIP/Postal Code
0488
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Axel R Sauter, PhD
Phone
93484022
Ext
+47
Email
axsa@online.no
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Maxillary Nerve Blocks in Children - An MRI Study of the Suprazygomatic Approach
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