Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2025-12-25 @ 9:53 PM
Study NCT ID:
NCT05351151
Status:
COMPLETED
Last Update Posted:
2025-11-28
First Post:
2022-04-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pain Reduction in Maxillomandibular Surgery Using Maxillary and Mandibular Nerve Blocks
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2023-03-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-21', 'studyFirstSubmitDate': '2022-04-22', 'studyFirstSubmitQcDate': '2022-04-22', 'lastUpdatePostDateStruct': {'date': '2025-11-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-04-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The opioid consumption (in Morphine Milligram Equivalents) after the first 24 hours post-surgery.', 'timeFrame': '24 hours post-surgery', 'description': 'The opioid consumption (in Morphine Milligram Equivalents ) after the first 24hours post-surgery.'}], 'secondaryOutcomes': [{'measure': 'Opioid consumption in Morphine Milligram Equivalents after the first 48 hours post-surgery.', 'timeFrame': '48 hours post-surgery', 'description': 'Evaluation of the total consumption of morphine equivalents (Oxycodone Hydrochloride) after the first 48 hours postoperative hour.'}, {'measure': 'Maximal pain (Numerical Rating Scale) in recovery room, at 24h after surgery.', 'timeFrame': '24 hours after surgery', 'description': 'Pain assessment by Simple Numerical Scale (ENS from 0 to 10) in the Postoperative Monitoring Room (maximum value) at the 24th postoperative hour'}, {'measure': 'Maximal pain (Numerical Rating Scale) in recovery room, at 48 hours after surgery.', 'timeFrame': '48 hours after surgery', 'description': 'Pain assessment by Simple Numerical Scale (ENS from 0 to 10) in the Postoperative Monitoring Room (maximum value) at the 48th postoperative hour.'}, {'measure': 'Incidence of opioid-Emergent Adverse Events [Safety and Tolerability]', 'timeFrame': '3 days', 'description': 'Measuring the incidence rate of common side effects associated with morphine drugs'}, {'measure': 'Evaluation of preoperative anxiety and fear using Amsterdam Preoperative Anxiety and Information Scale on post-surgical pain', 'timeFrame': 'pré-anesthesic visit (day -1 or day 0)', 'description': 'The patient\'s degree of pre-operative anxiety will be assessed using the Amsterdam Preoperative Anxiety and Information questionnaire in French Items are rated on a 5-point Likert scale ranging from 1 = "not at all" to 5 = "extremely"'}, {'measure': 'Evaluation of patient satisfaction about medical care', 'timeFrame': '3 days (maximum)', 'description': "The patient's feelings and satisfaction with their care will be evaluated by completing the questionnaire The feeling and satisfaction is rated according to a scale of 5 categories as follows: None, Low, Medium, High and Very High"}, {'measure': 'Incidence of regional anesthesia-Emergent Adverse Event [Safety and Tolerability]', 'timeFrame': '3 days', 'description': 'Measuring the incidence rate of common side effects associated with regional anesthesia'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Orthognathic surgery', 'Maxillary-mandibular osteotomy', 'Double jaw osteotomy', 'Bimaxillary surgery', 'Maxillary nerve block', 'Mandibular nerve block', 'Regional anesthesia', 'Nerve blocks'], 'conditions': ['Pain, Post Operative', 'Regional Anesthesia']}, 'referencesModule': {'references': [{'pmid': '38697776', 'type': 'RESULT', 'citation': 'Esquerre T, Mure M, Minville V, Prevost A, Lauwers F, Ferre F. Bilateral ultrasound-guided maxillary and mandibular combined nerves block reduces morphine consumption after double-jaw orthognathic surgery: a randomized controlled trial. Reg Anesth Pain Med. 2025 Jul 4;50(7):575-580. doi: 10.1136/rapm-2024-105497.'}]}, 'descriptionModule': {'briefSummary': 'Maxillo-mandibular osteotomy is a painful surgery which requires mostly opioids use. Recent studies on maxillary and mandibular nerve blocks have suggested benefit in maxillo-facial surgery but have been poorly investigated in orthognathic surgery. This study is designed to evaluate analgesic effectiveness, through opioids consumption, of a bilateral double ultra-sound guided nerve blocks (maxillar and mandibular nerve) in maxillo-mandibular osteotomy.', 'detailedDescription': 'Maxillo-mandibular osteotomy is a frequent but painful procedure in maxillo-facial surgery. It mostly requires opioids use which lead to well known side effects. Regional anesthesia has strongly modified post-surgical rehabilitation of many procedures. Maxillary nerve block has proved its efficiency on opioid consumption reduction in pediatric cleft palet surgery but has been rarely evaluated in orthognathic surgery. Mandibular nerve block has never been investigated in maxillo-mandibular osteotomy as well as benefit of bilateral ultra-sound guided technique to perform these nerve blocks. Consequently, this trial is designed to evaluate analgesic effectiveness of a double ultra-sound guided nerve blocks (maxillar and mandibular nerve) in maxillo-mandibular osteotomy.\n\nThis monocentric, single-blinded, randomized controled trial is designed with 2 groups of 25 patients receiving either bilateral double ultra-sound guided nerve block (maxillary and mandibular) with ROPIVACAINE 4.75mg/mL either local infiltration of LIDOCAINE 1% at incision sites by surgeon after general anesthesia induction during maxillo-mandibular osteotomy. Per et post-surgery anesthesic protocol and analgesia are standardized for both group. The main outcome corresponds to opioid consumption in MME of the first 24h after surgery. Follow-up occurs at 24h and 48h after end of surgery to assess analgesia, pain and opioid consumption.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '45 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients from 15 to 45 years old,\n* Scheduled for maxillary-mandibular osteotomy,\n* Registered in French social insurance register,\n* With informed consent disclosure.\n\nExclusion Criteria:\n\n* American Society of Anesthesiologists (ASA) classification ≥ 3\n* Innate or acquired hemostasis pathology,\n* Peripheric neuropathy,\n* Drug intake for chronic pain,\n* Infection/scar at needle insertion site,\n* Associated rhinoplasty surgery,\n* Allergy to local anesthetics,\n* Pregnant woman or potentially,\n* Breastfeeding woman,\n* Already registered in other clinical trial,\n* Adults under legal protection of incapable adult,\n* Cognitive disease impairing using of evaluation tools performed in protocol,\n* All contraindication of anesthetics drugs used in protocol.'}, 'identificationModule': {'nctId': 'NCT05351151', 'acronym': 'ECHOMAX', 'briefTitle': 'Pain Reduction in Maxillomandibular Surgery Using Maxillary and Mandibular Nerve Blocks', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Toulouse'}, 'officialTitle': 'Analgesic Efficacy of Echoguided Maxillary and Mandibular Nerve Blocks in Planned Maxillomandibular Osteotomy Surgery', 'orgStudyIdInfo': {'id': 'RC31/21/0509'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Loco Regional anesthesia (LRA)', 'description': 'The LRA group is made up of patients benefiting from the V2 and V3 ultrasound-guided LRA technique without mucosal infiltration.', 'interventionNames': ['Procedure: bilateral ultra-sound guided maxillary and mandibular nerve blocks']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Infiltration', 'description': 'The "Infiltration" group is made up of patients who benefit from the infiltration technique by local anesthesia of the incision sites by the surgeon without recourse to ultrasound-guided LRA.', 'interventionNames': ['Procedure: Infiltration of Lidocaine 1%']}], 'interventions': [{'name': 'bilateral ultra-sound guided maxillary and mandibular nerve blocks', 'type': 'PROCEDURE', 'description': 'Interventional group will receive bilateral ultra-sound guided maxillary and mandibular nerve block with ROPIVACAINE 4,75 mg/ml.', 'armGroupLabels': ['Loco Regional anesthesia (LRA)']}, {'name': 'Infiltration of Lidocaine 1%', 'type': 'PROCEDURE', 'description': 'Intervention requiring the infiltration of LIDOCAINE 1% at incision sites by surgeon after general anesthesia induction during maxillo-mandibular osteotomy', 'armGroupLabels': ['Infiltration']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31100', 'city': 'Toulouse', 'country': 'France', 'facility': 'University Hospital of Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'Marion MURE, Ph', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University hospital of Toulouse'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Toulouse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}