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临床试验/NCT03748329
NCT03748329已完成不适用

Ultrasound-guided Inferior Alveolar Nerve Block Study

University of Toronto1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2018年1月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
1
主要终点
Ultrasound vs Traditionally Landmarked Method

研究概览

简要总结

The primary objective is to compare the success of the inferior alveolar nerve block using ultrasound versus a traditional landmarking technique (which historically has an approximate failure rate as high as 33.8%). The secondary objective is to demonstrate that delivering a block under ultrasound guidance does not cause any additional pain to patients, as well as to reconfirm data shown in a previous study that the intra-oral transducer is well-tolerated among patients.

详细描述

Inferior alveolar nerve blocks are necessary to perform dental procedures in the mandible. The standard mandibular block (also known as the Halsted Technique, or the Inferior Alveolar Nerve Block) is based on intraoral landmarks but due to anatomical variation between patients, the failure rate, and therefore incomplete anaesthesia of the mandibular teeth, is high. Success rates have been reported anywhere from 66.2%-96.5% (Montagnese, 1984). Different approaches have been described to improve the success of blocking the inferior alveolar nerve but all have had varying rates of success (Blanton, 2002; Todorovic, 1986). Regardless, none are able to consistently and reliably block the inferior alveolar nerve one-hundred percent of the time.

Ultrasound is a valuable clinical tool to improve the accuracy of nerve blocks, and is also an important teaching tool. Ultrasound imaging is capable of identifying the relevant anatomy in the region of interest and has become common place during placement of spinal nerve blocks and many commonly recognized peripheral nerve blocks (Denny et Harrop-Griffiths, 2005). In studies of peripheral nerve blockade of the spine, the use of ultrasound should be able to reduce the number of needle passes required to achieve anaesthesia of a peripheral nerve and has been shown to reduce procedural times (Griffin et Nicholls, 2010). In addition, onset of sensory blockade is faster because of more intimate proximity of the needle tip to the nerve. Finally, the ability to visualize, and thereby ensure, the spread of local anaesthetic around the nerve also aids in the speed of onset of the block (Griffin et Nicholls, 2010). However, ultrasound has yet to be used successfully in intraoral trigeminal nerve blocks.

While Hannan et al. (1999) did compare ultrasonography to traditional landmarking for the inferior alveolar nerve block, there was no increase in success of the block. It should be noted that Hannan et al. was unable to visualize the nerve and instead used the inferior alveolar artery as a surrogate landmark to approximate proximity to the inferior alveolar nerve. Since the study by Hannan et al., there have been marked improvements to ultrasound hardware, i.e. transducers, and software, i.e. processors, to improve resolution and increase the ability to differentiate objects in soft tissue, specifically the neural structures from the vascular structures.

The inferior alveolar nerve itself can now be visualized by ultrasound in unembalmed human cadavers and can be accurately targeted with a needle by placing dye around the inferior alveolar nerve and confirmed by dissection performed by a blinded anatomist (Chanpong, 2013). The same study had a clinician consistently identify the inferior alveolar nerve bilaterally in 20 living individuals by ultrasound. In addition, according to the satisfaction survey performed, the intraoral ultrasound probe was just as comfortable as a bite block placed on the contralateral side. Based on a 10 point Likert scale (1 being very uncomfortable and 10 being very comfortable), the ultrasound probe scored a mean of 7.3 and the bite block a 7.5, and all 20 volunteers were able to complete bilateral scans. Given that the inferior alveolar nerve block can be easily visualized by ultrasound, the accuracy of needle placement may be significantly improved.

Adjacent to the inferior alveolar nerve are the inferior alveolar artery and the inferior alveolar vein. The risk of inadvertent vascular puncture of these vessels while performing an Inferior Alveolar Nerve Block has been reported to be anywhere from 2.6% to 30% (Malamed, 2013). By being able to guide the needle using ultrasound, the incidence of their puncture, and incidence of nerve puncture, may also be reduced.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Device Feasibility
盲法
Single (Participant)

盲法说明

The transducer will remain in place during the performance of the block but the monitor will be above the head of the patient in the 12 o'clock position so as to not be in direct view.

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •include male and female volunteers been the ages of 18 and 65 years old who can understand the study protocol and are able to give consent. Subjects must weigh between 40 kg and 100kg and fall under the American Society of Anesthesiology (ASA) classification I or II. At least one unrestored tooth distal to the lateral incisor must be present in both mandibular quadrants for EPT testing. Participants must also be able to open their mouth sufficiently to place a transducer and needle against the medial mandibular ramus.

排除标准

  • •include volunteers with serious medical conditions (ASA 3 or higher). Pregnant volunteers and those who have an allergy to mepivicaine or are on systemic anticoagulation will be excluded. Volunteers with infections, lesions, or anatomic anomalies at the site of the injection or have a pre-existing neurologic deficit in the mouth, head, or neck will also be excluded. Other exclusion criteria include volunteers who have taken any CNS depressants, opioids, non-steroidal anti-inflammatories, and/or acetaminophen in the 48 hours prior to testing. Subjects who are unable to speak English AND are unable to provide their own interpreter at all necessary appointments (screening, data collection, follow-up phone call) will be excluded as the data collection requires direct communication with one of the investigators (they are only English speaking) to discuss consent, instruction in the study, and possible post-operative adverse events and their associated management.

结局指标

主要结局

Ultrasound vs Traditionally Landmarked Method

时间窗: Immediate

Compare the success of the inferior alveolar nerve block using ultrasound versus a traditional landmarking technique using pulpal anaesthesia as assessed by an electric pulp tester.

次要结局

  • Comfort of ultrasound(Immediate)
  • Pain(Immediate)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Derek Decloux

Masters Student in Dental Anaesthesiology

University of Toronto

研究点 (1)

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