Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2025-12-25 @ 4:49 PM
Study NCT ID:
NCT05778903
Status:
RECRUITING
Last Update Posted:
2024-04-03
First Post:
2023-03-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Maxillary Nerve Blocks in Children - An MRI Study of the Suprazygomatic Approach
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002972', 'term': 'Cleft Palate'}, {'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D007569', 'term': 'Jaw Abnormalities'}, {'id': 'D007571', 'term': 'Jaw Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D019767', 'term': 'Maxillofacial Abnormalities'}, {'id': 'D019465', 'term': 'Craniofacial Abnormalities'}, {'id': 'D009139', 'term': 'Musculoskeletal Abnormalities'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D009056', 'term': 'Mouth Abnormalities'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D018640', 'term': 'Stomatognathic System Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009407', 'term': 'Nerve Block'}], 'ancestors': [{'id': 'D000765', 'term': 'Anesthesia, Conduction'}, {'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}, {'id': 'D003714', 'term': 'Denervation'}, {'id': 'D019635', 'term': 'Neurosurgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-06-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-02', 'studyFirstSubmitDate': '2023-03-08', 'studyFirstSubmitQcDate': '2023-03-20', 'lastUpdatePostDateStruct': {'date': '2024-04-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of LA spread into the PPF', 'timeFrame': 'day one - within an hour after intervention (peripheral nerve block)', 'description': 'Local anesthetic spread to the maxillaris nerve in the pterygopalatine fossa detected by MRI (binary outcome)'}], 'secondaryOutcomes': [{'measure': 'Rate of LA spread to other anatomical areas and structures', 'timeFrame': 'day one - within an hour after intervention (peripheral nerve block)', 'description': 'Local anaesthetic spread to orbita, nasal cavity, cranial fossa, infratemporal fossa, or other structures detected by MRI (binary outcome)'}, {'measure': 'Rate of hematoma', 'timeFrame': 'day one - within an hour after intervention (peripheral nerve block)', 'description': 'Accumulation of blood detected by MRI (binary outcome)'}, {'measure': 'Superior-inferior needle angle', 'timeFrame': 'day one - immediately after intervention (peripheral nerve block)', 'description': 'Angle of the injection needle meassured in a coronal plane'}, {'measure': 'Anterior-posterior needle angle', 'timeFrame': 'day one - immediately after intervention (peripheral nerve block)', 'description': 'Angle of the injection needle meassured in a sagittal plane'}, {'measure': 'Needle depth', 'timeFrame': 'day one - immediately after intervention (peripheral nerve block)', 'description': 'Depth of the injection needle'}, {'measure': 'Side effects and adverse events', 'timeFrame': 'day one', 'description': 'All side effects or adverse events that might be detected'}, {'measure': 'Postoperative analgesic consumption', 'timeFrame': 'day one and day two', 'description': 'Opioid consumption during the first 24 hours after surgery'}, {'measure': 'MRI time', 'timeFrame': 'day one', 'description': 'Time consumption for MRI'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Nerve Block', 'Cleft Palate', 'Analgesia']}, 'referencesModule': {'references': [{'pmid': '40216530', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '24 Months', 'minimumAge': '10 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Paediatric patients scheduled for cleft palate (CP) surgery with SMNB as part of their perioperative pain treatment\n* American Society of Anesthesiologists physical status 1 - 2\n* Age 10 to 24 months\n* Given informed written consent by legal guardian\n\nExclusion Criteria:\n\n* American Society of Anesthesiologists physical status \\> 2\n* Patients with cranial deformation\n* Patients with concomitant medical treatments or medical conditions interfering with peripheral nerve block treatment\n* Patients with concomitant medical treatments or medical conditions interfering with MRI\n* Patients that are allergic to bupivacaine or other local anaesthetic agents.'}, 'identificationModule': {'nctId': 'NCT05778903', 'briefTitle': 'Maxillary Nerve Blocks in Children - An MRI Study of the Suprazygomatic Approach', 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': 'Maxillary Nerve Blocks in Children - An MRI Study of the Suprazygomatic', 'orgStudyIdInfo': {'id': '563605'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Ultrasound guided Suprazygomatic Maxillary Nerve Block', '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.', 'interventionNames': ['Other: Nerve block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Landmark guided Suprazygomatic Maxillary Nerve Block landmark', '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.', 'interventionNames': ['Other: Nerve block']}], 'interventions': [{'name': 'Nerve block', 'type': 'OTHER', 'description': 'Suprazygomatic maxillary nerve block', 'armGroupLabels': ['Landmark guided Suprazygomatic Maxillary Nerve Block landmark', 'Ultrasound guided Suprazygomatic Maxillary Nerve Block']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0488', 'city': 'Oslo', 'status': 'RECRUITING', 'country': 'Norway', 'contacts': [{'name': 'Axel R Sauter, PhD', 'role': 'CONTACT', 'email': 'axsa@online.no', 'phone': '93484022', 'phoneExt': '+47'}], 'facility': 'Oslo University Hospital', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'centralContacts': [{'name': 'Axel Sauter, MD PhD', 'role': 'CONTACT', 'email': 'axsa@online.no', 'phone': '93484022', 'phoneExt': '+47'}, {'name': 'Nergis Suleiman, MD', 'role': 'CONTACT', 'email': 'nergis.nina.suleiman@gmail.com', 'phone': '23070000', 'phoneExt': '+47'}], 'overallOfficials': [{'name': 'Axel Sauter, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oslo University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Axel R. Sauter', 'investigatorAffiliation': 'Oslo University Hospital'}}}}