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临床试验/NCT04961554
NCT04961554撤回不适用

Locoregional Anesthesia of the V3 and Limited Mouth Opening

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家开始时间: 2023年4月2日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Measure of patient's mouth opening

研究概览

简要总结

Trismus is an involuntary contracture of the masticatory muscles, blocking the opening of the jaw, first intermittent then permanent and irreducible. Trismus is the result of pain or spasm or even muscle fibrosis, due to infectious, inflammatory or tumoral involvement of the masticatory muscles.

During any anesthesia, control of the patient's upper airways is a major issue. Orotracheal intubation is the gold standard. Trismus will therefore complicate this management of the airways. This trismus can prevent the realization of a classic intubation, by the inability to use a laryngoscope or video laryngoscope, in favor of awake fiberoptic intubation, a technique that causes discomfort during the procedure, then a state of post-traumatic stress.

Mandibular block is increasingly used in the analgesia of mandibular surgeries thanks to the simplicity of the technique and its good efficiency. It has been described that the mandibular locoregional anesthesia made it possible to remove the trismus due to a dental infection, allowing the realization of a surgical gesture under good conditions. In addition, authors have described V3 block as a technique that could improve the safety of anesthesia in patients with acute trismus, by avoiding the need for awake nasofibroscopy intubation. One study showed that performing locoregional anesthesia of the mandibular nerve improved the mouth opening in patients with mandibular fracture. The investigators wondered if this locoregional anesthesia could also work on other types of trismus such as infectious, tumoral and osteoradionecrosis trismus.

During preoperative consultation, anesthesists usually measure the mouth opening. In our study, anesthesists will also measure the mouth opening after performing locoregional anesthesia of the V3 nerve (mandibular block). In addition to the measurement made before the start of the anesthetic treatment, research provides for three other measurements of the mouth opening using a rule (millimeters), taken at different times : after sedation, after performing locoregional anesthesia and after curarization. The investigators will also collect the cause of the limited mouth opening, the duration of development. The investigators will study pain at rest and when opening the mouth, under sedation, when performing the block, then when opening the mouth after performing the block. The presence of edema next to the area of locoregional anesthesia, the type of product used for sedation and locoregional anesthesia, the intubation technique performed, as well as the difficulty experienced by the operator will be collected

详细描述

The aim of this study is to avoid recourse to awake fiberoptic intubation, which causes discomfort during the procedure and post-traumatic stress disorder, in patients with a very limited mouth opening (less than 20mm) and who must undergo anesthesia general for mandibular surgery.

As a reminder, the definition of limited mouth opening (MO) is a lower 35mm mouth opening, according to the Société française d'anesthésie-réanimation (SFAR) recommendations. The investigators define a very limited mouth opening as a mouth opening that does not allow a video laryngoscope blade to be inserted into the patient's mouth (less than 20mm).

During preoperative consultation, anesthesists usually measure the mouth opening. In our study, anesthesists will also measure the mouth opening after performing locoregional anesthesia of the V3 nerve (mandibular block). In addition to the measurement made before the start of the anesthetic treatment, research provides for three other measurements of the mouth opening using a rule, taken at different times.

The management is carried out exclusively by the investigators, the latter being anesthetists. Thus, the evaluation of the different mouth openings using a ruler (in millimeters), the evaluation of the pain using the numerical scale, the administration of sedation, the realization of loco-regional anesthesia, intraoperative and postoperative anesthetic management will be carried out by one and the same person qualified in anesthesia for maxillofacial surgery.

In summary, six key steps for our study will be carried out by the anesthetist-resuscitator:

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 18 years old
  • Patient with a mouth opening defined as very limited (<20mm)
  • Patient scheduled for mandibular surgery, with an indication for a V3 block for analgesic purposes
  • Patient informed and not opposed to the study

排除标准

  • Allergy to local anesthetics
  • Patient under judicial protection

结局指标

主要结局

Measure of patient's mouth opening

时间窗: during surgery

The main outcome is the measure of patient's mouth opening (in millimeters) in the minutes preceding and following the mandibular block. The mouth opening will be measured using a ruler with 4 defined times: * Before any anesthesia * After sedation * 15min from the realization of the loco-regional anesthesia * After curarization, just before intubation. These different measurements will be carried out by a ruler, and by a single operator for these 4 measurements.

次要结局

  • Mallampati score(before locoregional anesthesia)
  • Assessement of Etiology of limited mouth opening (osteoradionecrosis, tumor, infection)(during surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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