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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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.

Detailed Summary:
Sponsor: University Hospital, Montpellier

Current Primary Outcome:

  • consumption of morphine (cumulative dose) during the first post operative 24 hours valued in mg [ Time Frame: 1 day ]
  • consumption of morphine (cumulative dose) during the first post operative 24 hours detected thanks to the "Patient Controlled Analgesia" [ Time Frame: 1 day ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Tolerability : effects of the block on nausea / vomiting (consumption of antiemetic in mg) during the first post operative 24 hours [ Time Frame: 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 [ Time Frame: 1 day ]
  • postoperative bleeding (in mL) [ Time Frame: 1 day ]


Original Secondary Outcome: Same as current

Information By: University Hospital, Montpellier

Dates:
Date Received: November 3, 2015
Date Started: December 2015
Date Completion: December 2017
Last Updated: November 17, 2016
Last Verified: November 2016