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

Orthognathic Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02618993
• Other study ID #: 9560
• Secondary ID: 2015-001345-88
• Status: Completed
• Phase: Phase 3
• Start date: December 2015
• Est. completion date: December 30, 2018

Study information

• Verified date: April 2022
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: December 30, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Mandibular Fracture Trauma
• Mandibular Fractures
• Maxillofacial Osteotomy
• Orthognathic Surgery

Intervention

Procedure:
• Realization of the V3 block in maxillofacial surgeries
bilateral mandibular block in maxillofacial surgeries

Locations

Country	Name	City	State
France	Hôpital Gui de Chauliac	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	consumption of morphine (cumulative dose) during the first post operative 24 hours valued in mg		1 day
Primary	consumption of morphine (cumulative dose) during the first post operative 24 hours detected thanks to the "Patient Controlled Analgesia"		1 day
Secondary	Tolerability : effects of the block on nausea / vomiting (consumption of antiemetic in mg) during the first post operative 24 hours		1 day
Secondary	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
Secondary	postoperative bleeding (in mL)		1 day