Effects of the Bilateral Mandibular Nerve Block (V3) in Mandibular Osteotomy: a Prospective, Randomized, Double-blind Versus Placebo Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- consumption of morphine (cumulative dose) during the first post operative 24 hours valued in mg
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
consumption of morphine (cumulative dose) during the first post operative 24 hours valued in mg
时间窗: 1 day
consumption of morphine (cumulative dose) during the first post operative 24 hours detected thanks to the "Patient Controlled Analgesia"
时间窗: 1 day
次要结局
- 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)
- Tolerability : effects of the block on nausea / vomiting (consumption of antiemetic in mg) during the first post operative 24 hours(1 day)