Effects of the Bilateral Mandibular Nerve Block (V3) in Mandibular Osteotomy

Study Overview
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Brief Summary
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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.

Official Title
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Effects of the Bilateral Mandibular Nerve Block (V3) in Mandibular Osteotomy: a Prospective, Randomized, Double-blind Versus Placebo Study

Conditions
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Mandibular Fracture Trauma, Orthognathic Surgery, Maxillofacial Osteotomy

Intervention / Treatment
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* Procedure: Realization of the V3 block in maxillofacial surgeries


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult patients and patients from 15 to 18 years old with mandibular trauma or orthognathic surgery Affiliated to a national insurance scheme to have signed the informed consent of this study Physical status score 1-3 Exclusion Criteria: allergy to local anesthetics severe coagulopathy hypovolemic patient 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. Pregnant or breast-feeding women according to the article L1121-5 of the Code of the Health Public. Vulnerable People.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control group<br>Control group: Realization of the V3 block with a placebo in maxillofacial surgeries | Procedure: Realization of the V3 block in maxillofacial surgeries<br>* bilateral mandibular block in maxillofacial surgeries<br>|
| Experimental: Loco-regional anesthesia (LRA) group<br>Loco-regional anesthesia (LRA) group: Realization of the V3 block with Ropivacaine in maxillofacial surgeries | Procedure: Realization of the V3 block in maxillofacial surgeries<br>* bilateral mandibular block in maxillofacial surgeries<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| consumption of morphine (cumulative dose) during the first post operative 24 hours valued in mg |  | 1 day | 
| consumption of morphine (cumulative dose) during the first post operative 24 hours detected thanks to the Patient Controlled Analgesia |  | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability : effects of the block on nausea / vomiting (consumption of antiemetic in mg) during the first post operative 24 hours |  | 1 day | 
| 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 |  | 1 day | 
| postoperative bleeding (in mL) |  | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mandibular nerve block, mandibular osteotomy