Mandibular Fracture TraumaPhase 3NCT02618993
Effects of the Bilateral Mandibular Nerve Block (V3) in Mandibular Osteotomy
A Phase 3 study testing Realization of the V3 block in maxillofacial surgeries in people with Mandibular Fracture Trauma and Orthognathic Surgery, run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Mandibular Fracture Trauma, Orthognathic Surgery, Maxillofacial Osteotomy
- What is being tested?
- Realization of the V3 block in maxillofacial surgeries
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2015to 30 Dec 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of the Bilateral Mandibular Nerve Block (V3) in Mandibular Osteotomy: a Prospective, Randomized, Double-blind Versus Placebo Study
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.
- Being tested
- Realization of the V3 block in maxillofacial surgeries
- Keywords
- mandibular nerve block, mandibular osteotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Realization of the V3 block in maxillofacial surgeriesProcedure or surgery
bilateral mandibular block in maxillofacial surgeries
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | Control group: Realization of the V3 block with a placebo in maxillofacial surgeries Receives: 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 Receives: Procedure: Realization of the V3 block in maxillofacial surgeries |
What is being measured
The primary outcome is the main question the study is designed to answer.
consumption of morphine (cumulative dose) during the first post operative 24 hours valued in mg
Measured: 1 day
consumption of morphine (cumulative dose) during the first post operative 24 hours detected thanks to the "Patient Controlled Analgesia"
Measured: 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
Measured: 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
Measured: 1 day
postoperative bleeding (in mL)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2015 (estimated)
- Study startDec 2015
- Primary completion30 Jun 2018
- Study completion30 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mandibular Fracture TraumaStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre-François PERRIGAULT, MD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02618993
- Sponsor's protocol ID
- 9560
- Other IDs
- 2015-001345-88, 2015
- Status last verified
- Apr 2022
- First submitted
- 3 Nov 2015
- Last updated
- 14 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 33563767
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Bilateral Mandibular Nerve Block (V3) in Mandibular Osteotomy: a Prospective, Randomized, Double-blind Versus Placebo Study
- ClinicalTrials.gov ID
- NCT02618993
- Acronym / sponsor ID
- 9560
- Keywords
- mandibular nerve block, mandibular osteotomy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Dec 2015 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 2 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Procedure: Realization of the V3 block in maxillofacial surgeriesControl group: Realization of the V3 block with a placebo in maxillofacial surgeries |
| Loco-regional anesthesia (LRA) group | Experimental | Procedure: Realization of the V3 block in maxillofacial surgeriesLoco-regional anesthesia (LRA) group: Realization of the V3 block with Ropivacaine in maxillofacial surgeries |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Realization of the V3 block in maxillofacial surgeriesbilateral mandibular block in maxillofacial surgeries | Procedure or surgery | Control group, Loco-regional anesthesia (LRA) group |
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
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2022.
- Derived from this study: PubMed 33563767Bertuit 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre-François PERRIGAULT, MD principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Realization of the V3 block in maxillofacial surgeries in people with Mandibular Fracture Trauma and Orthognathic Surgery, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
consumption of morphine (cumulative dose) during the first post operative 24 hours valued in mg (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02618993, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2022.