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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-001345-88 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Placebo Comparator | Control group: Realization of the V3 block with a placebo in maxillofacial surgeries |
|
| Loco-regional anesthesia (LRA) group | Experimental | Loco-regional anesthesia (LRA) group: Realization of the V3 block with Ropivacaine in maxillofacial surgeries |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Realization of the V3 block in maxillofacial surgeries | Procedure | bilateral mandibular block in maxillofacial surgeries |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pierre-François PERRIGAULT, MD | Montpellier University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Gui de Chauliac | Montpellier | 34295 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33563767 | Derived | 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. |
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| 1 day |
| postoperative bleeding (in mL) | 1 day |