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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2018-12-30

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.

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Detailed Description

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Conditions

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Mandibular Fracture Trauma Orthognathic Surgery Maxillofacial Osteotomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Control group

Control group: Realization of the V3 block with a placebo in maxillofacial surgeries

Group Type PLACEBO_COMPARATOR

Realization of the V3 block in maxillofacial surgeries

Intervention Type PROCEDURE

bilateral mandibular block in maxillofacial surgeries

Loco-regional anesthesia (LRA) group

Loco-regional anesthesia (LRA) group: Realization of the V3 block with Ropivacaine in maxillofacial surgeries

Group Type EXPERIMENTAL

Realization of the V3 block in maxillofacial surgeries

Intervention Type PROCEDURE

bilateral mandibular block in maxillofacial surgeries

Interventions

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Realization of the V3 block in maxillofacial surgeries

bilateral mandibular block in maxillofacial surgeries

Intervention Type PROCEDURE

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No