Clinical trial NCT02618993: Effects of the Bilateral Mandibular Nerve Block (V3) in Mandibular Osteotomy
Official title: Effects of the Bilateral Mandibular Nerve Block (V3) in Mandibular Osteotomy: a Prospective, Randomized, Double-blind Versus Placebo Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Mandibular Fracture Trauma
Orthognathic Surgery
Maxillofacial Osteotomy
Keywords: mandibular nerve block
mandibular osteotomy
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2015-12-02
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: consumption of morphine (cumulative dose) during the first post operative 24 hours valued in mg
timeFrame: 1 day
measure: consumption of morphine (cumulative dose) during the first post operative 24 hours detected thanks to the "Patient Controlled Analgesia"
timeFrame: 1 day
Secondary outcomes:
measure: Tolerability : effects of the block on nausea / vomiting (consumption of antiemetic in mg) during the first post operative 24 hours
timeFrame: 1 day
measure: 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
timeFrame: 1 day
measure: postoperative bleeding (in mL)
timeFrame: 1 day
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Hôpital Gui de Chauliac
Study officials:
affiliation: Montpellier University Hospital
name: Pierre-François PERRIGAULT, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.