NCT02618993

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Dec 2015

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 3, 2015

Completed
28 days until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 2, 2015

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2018

Completed
Last Updated

April 14, 2022

Status Verified

April 1, 2022

Enrollment Period

2.6 years

First QC Date

November 3, 2015

Last Update Submit

April 13, 2022

Conditions

Mandibular Fracture TraumaOrthognathic SurgeryMaxillofacial Osteotomy

Keywords

mandibular nerve blockmandibular osteotomy

Outcome Measures

Primary Outcomes (2)

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

    1 day

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

    1 day

Secondary Outcomes (3)

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

    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

    1 day

  • postoperative bleeding (in mL)

    1 day

Study Arms (2)

Control group

PLACEBO COMPARATOR

Control group: Realization of the V3 block with a placebo in maxillofacial surgeries

Procedure: Realization of the V3 block in maxillofacial surgeries

Loco-regional anesthesia (LRA) group

EXPERIMENTAL

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

Procedure: Realization of the V3 block in maxillofacial surgeries

Interventions

Realization of the V3 block in maxillofacial surgeriesPROCEDURE

bilateral mandibular block in maxillofacial surgeries

Control groupLoco-regional anesthesia (LRA) group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Gui de Chauliac

Montpellier, 34295, France

Location

Related Publications (1)

  • 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.

    PMID: 33563767DERIVED

Study Officials

  • Pierre-François PERRIGAULT, MD

    Montpellier University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2015

First Posted

December 2, 2015

Study Start

December 1, 2015

Primary Completion

June 30, 2018

Study Completion

December 30, 2018

Last Updated

April 14, 2022

Record last verified: 2022-04

Locations

FR(1)