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Completed

NCT Number: NCT02618993

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

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.

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Key information

Conditions

Mandibular Fracture Trauma Maxillofacial Osteotomy Orthognathic Surgery

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hôpital Gui de Chauliac

Montpellier, 34295, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Realization of the V3 block in maxillofacial surgeries

Procedure

bilateral mandibular block in maxillofacial surgeries

Primary outcomes

  1. consumption of morphine (cumulative dose) during the first post operative 24 hours valued in mg

    Time frame: 1 day

  2. consumption of morphine (cumulative dose) during the first post operative 24 hours detected thanks to the "Patient Controlled Analgesia"

    Time frame: 1 day

Secondary outcomes

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

    Time frame: 1 day

  2. 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

    Time frame: 1 day

  3. postoperative bleeding (in mL)

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Dec 2, 2015
Registry last updated
Apr 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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