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临床试验/NCT03669744
NCT03669744已完成不适用

Regional Anesthesia in Refractory Trigeminal Neuralgia: 21 Cases Reported to the Limoges University Hospital

University Hospital, Limoges1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2018年10月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
21
试验地点
1
主要终点
Change of the quality of life from baseline to day 15 after baseline

研究概览

简要总结

Trigeminal neuralgia is defined according to the third edition of the International Classification of Headache Disorders (ICHD-3) criteria. Chronic pain can have a major impact on the quality of life. First-line treatments are anti-epileptics, and surgical treatments are also possible according to several approaches. Sometimes the pain is resistant to these therapies. In this indication, sensory blocks may have a therapeutic impact but their place is not clear. In France, there are formalized expert recommendations on "loco regional analgesia and chronic pain", from 2013. Several adjuvants to local anesthetics have been studied for acute and chronic pain. CLONIDINE and DEXAMETHASONE are of greatest interest in increasing block duration and reducing opioid consumption. The investigators report the case of 21 patients, treated by a trigeminal block from 2014 to 2018, suffering from a resistant trigeminal neuralgia. After a first consultation, the diagnosis is confirmed, an information is done and an appropriate support is established. The sensory block is performed as an outpatient care. It consists in a peri-neural injection of a mixture of LEVOBUPIVACAINE 5%, CORTIVAZOL 3.75mg / 1.5mL (or BETAMETHASONE 7mg / 1ml) and CLONIDINE (1μg / kg). Standard precautions are respected and patients are monitored in the recovery room after the procedure. The efficacity is evaluated before the exit and a follow-up is done within 15 days. The level of satisfaction expressed by the patients seems to be globally high. The investigators wish to evaluate statistically the impact of the trigeminal blocks, in terms of improvement of the quality of life. This retrospective study, by its procedure, does not change the management of patients.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

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

入选标准

  • Major patients with trigeminal neuralgia resistant to usual treatments, according to the ICHD-3β criteria
  • treating by one or more trigeminal nerve blocks
  • at the peri operative pain management center of Limoges University Hospital
  • between 2014 and 2018

排除标准

  • Not consent
  • Another type of facial block during the previous year.
  • Unavailable medical data
  • Deceased patient

结局指标

主要结局

Change of the quality of life from baseline to day 15 after baseline

时间窗: Day 0, Day 15

Percentage of patients with improvement of more than 50% in quality of life, mesured with the 'Medical Outcome Study Short Form 12', from baseline (day 0 = just before the block) to day 15. The questionnaire consists of 12 items questioned weighted and summed to provide physical and mental health scores (PCS and MCS). The two composite scores are computed using the scores on twelve questions that range from 0 to 100, with higher score indicating better health.

次要结局

  • Patient overall satisfaction assessed by a Numerical Rating Scale.(Day 0)
  • Impact on analgesics consumption assessed by the dosage of analgesics(Day 0)
  • Side effects(Day 0)
  • Change in pain level just before and after the block assessed by a numerical scoring scale(Day 0, Day 15)
  • Duration of the block(Day 0)
  • Return to work(Day 0)
  • Return to hobbies(Day 0)
  • Neuropathic criteria of pain just before and after the block assessed by DN4(Day 0)

研究者

发起方
University Hospital, Limoges
申办方类型
Other
责任方
Sponsor

研究点 (1)

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