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

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

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.

Study Overview

• Status: Completed
• Conditions: Orthognathic Surgery; Mandibular Fracture Trauma; Maxillofacial Osteotomy
• Intervention / Treatment: Procedure: Realization of the V3 block in maxillofacial surgeries

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • Hopital Gui de Chauliac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Principal Investigator: Pierre-François PERRIGAULT, MD, Montpellier University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2015
• Primary Completion (Actual): June 30, 2018
• Study Completion (Actual): December 30, 2018

Study Registration Dates

• First Submitted: November 3, 2015
• First Submitted That Met QC Criteria: November 27, 2015
• First Posted (Estimate): December 2, 2015

Study Record Updates

• Last Update Posted (Actual): April 14, 2022
• Last Update Submitted That Met QC Criteria: April 13, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: mandibular nerve block; mandibular osteotomy
• Additional Relevant MeSH Terms: Nervous System Diseases; Fractures, Bone; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Jaw Fractures; Maxillofacial Injuries; Facial Injuries; Skull Fractures; Mandibular Fractures
• Other Study ID Numbers: 9560; 2015-001345-88 (EudraCT Number)