Effects of the Bilateral Mandibular Nerve Block (V3) in Mandibular Osteotomy
Primary Purpose
Mandibular Fracture Trauma, Orthognathic Surgery, Maxillofacial Osteotomy
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Realization of the V3 block in maxillofacial surgeries
Sponsored by
About this trial
This is an interventional treatment trial for Mandibular Fracture Trauma focused on measuring mandibular nerve block, mandibular osteotomy
Eligibility 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.
Sites / Locations
- Hôpital Gui de Chauliac
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Control group
Loco-regional anesthesia (LRA) group
Arm Description
Control group: Realization of the V3 block with a placebo in maxillofacial surgeries
Loco-regional anesthesia (LRA) group: Realization of the V3 block with Ropivacaine in maxillofacial surgeries
Outcomes
Primary Outcome Measures
consumption of morphine (cumulative dose) during the first post operative 24 hours valued in mg
consumption of morphine (cumulative dose) during the first post operative 24 hours detected thanks to the "Patient Controlled Analgesia"
Secondary Outcome Measures
Tolerability : effects of the block on nausea / vomiting (consumption of antiemetic in mg) during the first post operative 24 hours
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
postoperative bleeding (in mL)
Full Information
NCT ID
NCT02618993
First Posted
November 3, 2015
Last Updated
April 13, 2022
Sponsor
University Hospital, Montpellier
1. Study Identification
Unique Protocol Identification Number
NCT02618993
Brief Title
Effects of the Bilateral Mandibular Nerve Block (V3) in Mandibular Osteotomy
Official Title
Effects of the Bilateral Mandibular Nerve Block (V3) in Mandibular Osteotomy: a Prospective, Randomized, Double-blind Versus Placebo Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
December 2015 (Actual)
Primary Completion Date
June 30, 2018 (Actual)
Study Completion Date
December 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mandibular Fracture Trauma, Orthognathic Surgery, Maxillofacial Osteotomy
Keywords
mandibular nerve block, mandibular osteotomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
108 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Control group: Realization of the V3 block with a placebo in maxillofacial surgeries
Arm Title
Loco-regional anesthesia (LRA) group
Arm Type
Experimental
Arm Description
Loco-regional anesthesia (LRA) group: Realization of the V3 block with Ropivacaine in maxillofacial surgeries
Intervention Type
Procedure
Intervention Name(s)
Realization of the V3 block in maxillofacial surgeries
Intervention Description
bilateral mandibular block in maxillofacial surgeries
Primary Outcome Measure Information:
Title
consumption of morphine (cumulative dose) during the first post operative 24 hours valued in mg
Time Frame
1 day
Title
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 Measure Information:
Title
Tolerability : effects of the block on nausea / vomiting (consumption of antiemetic in mg) during the first post operative 24 hours
Time Frame
1 day
Title
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
Title
postoperative bleeding (in mL)
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre-François PERRIGAULT, MD
Organizational Affiliation
Montpellier University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Gui de Chauliac
City
Montpellier
ZIP/Postal Code
34295
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
33563767
Citation
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.
Results Reference
derived
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Effects of the Bilateral Mandibular Nerve Block (V3) in Mandibular Osteotomy
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