Effects of the Bilateral Mandibular Nerve Block (V3) in Mandibular Osteotomy (NCT02618993) | Clinical Trial Compass
CompletedPhase 3
Effects of the Bilateral Mandibular Nerve Block (V3) in Mandibular Osteotomy
France108 participantsStarted 2015-12
Plain-language 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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
consumption of morphine (cumulative dose) during the first post operative 24 hours valued in mg
Timeframe: 1 day
2
consumption of morphine (cumulative dose) during the first post operative 24 hours detected thanks to the "Patient Controlled Analgesia"