Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2026-02-24 @ 4:11 AM
Study NCT ID:
NCT02618993
Status:
COMPLETED
Last Update Posted:
2022-04-14
First Post:
2015-11-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of the Bilateral Mandibular Nerve Block (V3) in Mandibular Osteotomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 108}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2018-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-13', 'studyFirstSubmitDate': '2015-11-03', 'studyFirstSubmitQcDate': '2015-11-27', 'lastUpdatePostDateStruct': {'date': '2022-04-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'consumption of morphine (cumulative dose) during the first post operative 24 hours valued in mg', 'timeFrame': '1 day'}, {'measure': 'consumption of morphine (cumulative dose) during the first post operative 24 hours detected thanks to the "Patient Controlled Analgesia"', 'timeFrame': '1 day'}], 'secondaryOutcomes': [{'measure': 'Tolerability : effects of the block on nausea / vomiting (consumption of antiemetic in mg) during the first post operative 24 hours', 'timeFrame': '1 day'}, {'measure': 'Postoperative pain valued thanks to Visual Analog Scale (VAS), VAS max in post anesthesia care units (PACU) every 30 minutes and in department every 4 hours', 'timeFrame': '1 day'}, {'measure': 'postoperative bleeding (in mL)', 'timeFrame': '1 day'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['mandibular nerve block', 'mandibular osteotomy'], 'conditions': ['Mandibular Fracture Trauma', 'Orthognathic Surgery', 'Maxillofacial Osteotomy']}, 'referencesModule': {'references': [{'pmid': '33563767', 'type': 'DERIVED', 'citation': 'Bertuit M, Rapido F, Ly H, Vannucci C, Ridolfo J, Molinari N, De Boutray M, Galmiche S, Dadure C, Perrigault PF, Capdevila X, Chanques G. Bilateral mandibular block improves pain relief and morphine consumption in mandibular osteotomies: a prospective, randomized, double-blind, placebo-controlled clinical trial. Reg Anesth Pain Med. 2021 Apr;46(4):322-327. doi: 10.1136/rapm-2020-102417. Epub 2021 Feb 9.'}]}, 'descriptionModule': {'briefSummary': 'The sensory innervation of the face depends on the trigeminal (fifth cranial) which is divided into three branches, the mandibular nerve (V3) having motor fibers to the temporal and masseter muscle. The regional anesthesia of the face has grown in recent years for performing certain actions under light general anesthesia or sedation. The mandibular block is a simple and reliable technique but little used. Yet it reduces postoperative pain sagittal osteotomy of the mandibular branch by reducing consumption of opioids and in the oropharynx cancer surgery. Made with ropivacaine, known for its vasoconstrictive action, it also improves the visibility of the operative field during mandibular osteotomies reducing bleeding. Despite a real clinical benefit (ease of implementation, latency and duration of action of the local anesthetic), the V3 block ropivacaine is not evaluated in the maxillofacial surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients and patients from 15 to 18 years old\n* with mandibular trauma or orthognathic surgery\n* Affiliated to a national insurance scheme\n* to have signed the informed consent of this study\n* Physical status score 1-3\n\nExclusion Criteria:\n\n* allergy to local anesthetics\n* severe coagulopathy\n* hypovolemic patient\n* Protected minor or major patients or in the incapacity to give his consent according to the article L1121-8 of the Code of the Health Public.\n* Pregnant or breast-feeding women according to the article L1121-5 of the Code of the Health Public.\n* Vulnerable People.'}, 'identificationModule': {'nctId': 'NCT02618993', 'briefTitle': 'Effects of the Bilateral Mandibular Nerve Block (V3) in Mandibular Osteotomy', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Effects of the Bilateral Mandibular Nerve Block (V3) in Mandibular Osteotomy: a Prospective, Randomized, Double-blind Versus Placebo Study', 'orgStudyIdInfo': {'id': '9560'}, 'secondaryIdInfos': [{'id': '2015-001345-88', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'Control group: Realization of the V3 block with a placebo in maxillofacial surgeries', 'interventionNames': ['Procedure: Realization of the V3 block in maxillofacial surgeries']}, {'type': 'EXPERIMENTAL', 'label': 'Loco-regional anesthesia (LRA) group', 'description': 'Loco-regional anesthesia (LRA) group: Realization of the V3 block with Ropivacaine in maxillofacial surgeries', 'interventionNames': ['Procedure: Realization of the V3 block in maxillofacial surgeries']}], 'interventions': [{'name': 'Realization of the V3 block in maxillofacial surgeries', 'type': 'PROCEDURE', 'description': 'bilateral mandibular block in maxillofacial surgeries', 'armGroupLabels': ['Control group', 'Loco-regional anesthesia (LRA) group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'Hôpital Gui de Chauliac', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'overallOfficials': [{'name': 'Pierre-François PERRIGAULT, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Montpellier University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}