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

Phase 3

Completed

• Conditions: Orthognathic Surgery; Maxillofacial Osteotomy; Mandibular Fracture Trauma
• Interventions: Procedure: Realization of the V3 block in maxillofacial surgeries

• Registration Number: NCT02618993
• Lead Sponsor: University Hospital, Montpellier

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-11-03
• Study First Submitted QC: 2015-11-27
• Study Start: 2015-12
• Study First Posted: 2015-12-02
• Primary Completion: 2018-06-30
• Study Completion: 2018-12-30
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-13
• Last Update Posted: 2022-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Loco-regional anesthesia (LRA) group	Realization of the V3 block in maxillofacial surgeries	Loco-regional anesthesia (LRA) group: Realization of the V3 block with Ropivacaine in maxillofacial surgeries
Control group	Realization of the V3 block in maxillofacial surgeries	Control group: Realization of the V3 block with a placebo in maxillofacial surgeries

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
Tolerability : effects of the block on nausea / vomiting (consumption of antiemetic in mg) during the first post operative 24 hours	1 day

Trial Locations

Locations (1)

Hôpital Gui de Chauliac; 🇫🇷 Montpellier, France