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Trial record 18 of 28 for:    Recruiting, Not yet recruiting, Available Studies | "Facial Injuries"

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

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ClinicalTrials.gov Identifier: NCT02618993
Recruitment Status : Recruiting
First Posted : December 2, 2015
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

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.

Condition or disease Intervention/treatment Phase
Mandibular Fracture Trauma Orthognathic Surgery Maxillofacial Osteotomy Procedure: Realization of the V3 block in maxillofacial surgeries Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effects of the Bilateral Mandibular Nerve Block (V3) in Mandibular Osteotomy: a Prospective, Randomized, Double-blind Versus Placebo Study
Study Start Date : December 2015
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : December 2018

Arm Intervention/treatment
Placebo Comparator: Control group
Control group: Realization of the V3 block with a placebo in maxillofacial surgeries
Procedure: Realization of the V3 block in maxillofacial surgeries
bilateral mandibular block in maxillofacial surgeries

Experimental: Loco-regional anesthesia (LRA) group
Loco-regional anesthesia (LRA) group: Realization of the V3 block with Ropivacaine in maxillofacial surgeries
Procedure: Realization of the V3 block in maxillofacial surgeries
bilateral mandibular block in maxillofacial surgeries




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02618993


Contacts
Contact: Pierre-François PERRIGAULT, MD +33467337687 ext 0033 pf-perrigault@chu-montpellier.fr
Contact: Charlotte Vannucci, MD +33467337687 ext 0033 Charlotte-vannucci@chu-montpellier.fr

Locations
France
Hôpital Gui de Chauliac Recruiting
Montpellier, France, 34295
Contact: Pierre-François PERRIGAULT, MD    +33467337687 ext 0033    pf-perrigault@chu-montpellier.fr   
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
Principal Investigator: Pierre-François PERRIGAULT, MD Montpellier University Hospital

Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT02618993     History of Changes
Other Study ID Numbers: 9560
2015-001345-88 ( EudraCT Number )
First Posted: December 2, 2015    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: November 2016

Keywords provided by University Hospital, Montpellier:
mandibular nerve block
mandibular osteotomy

Additional relevant MeSH terms:
Mandibular Fractures
Jaw Fractures
Maxillofacial Injuries
Facial Injuries
Craniocerebral Trauma
Trauma, Nervous System
Nervous System Diseases
Skull Fractures
Fractures, Bone
Wounds and Injuries