跳至主要内容
临床试验/NCT06121102
NCT06121102招募中不适用

Standard Pulsed Radiofrequency Versus Supervoltage Pulsed Radiofrequency Glossopharyngeal Nerve Therapy in Management of Oropharyngeal Cancer Pain: Randomized Clinical Trial.

National Cancer Institute, Egypt2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年11月8日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
2
主要终点
The degree of pain

研究概览

简要总结

The aim of this study is to evaluate the safety and efficacy of supervoltage pulsed radiofrequency glossopharyngeal nerve therapy versus standard pulsed radiofrequency in reduction of oropharyngeal cancer pain, through Visual analog scale score reduction.

详细描述

The glossopharyngeal nerve is the 9th cranial nerve. It has motor, sensory and parasympathetic function like trigeminal and facial nerves. It has its origin in the medulla oblongata and exits the skull via the jugular foramen, close to vagus and accessory nerves, together with the internal carotid artery and sympathetic nerves and terminates in the pharynx between the superior and middle pharyngeal constrictors, splitting into its terminal branches - lingual, pharyngeal, and tonsillar. Glossopharyngeal neuralgia is an extremely uncommon occurrence and accounts for only 0.2%-1.3% of the cases with facial pain. It usually affects the male individuals above 50-year age, and the reported incidence of glossopharyngeal neuralgia is roughly 0.8 per 100,000 persons per year. As per ICHD-3 (International Classification of Headache Disease- 3) classification, glossopharyngeal neuralgia is a disease characterized by an episodic unilateral pain, with sharp and stabbing in character, with sudden onset and cessation, in the glossopharyngeal nerve distribution (jaw angle, ear, tonsillar fossa and the base of the tongue). It also affect the pharyngeal and auricular branches of the vagus nerve. Pain is commonly aggravated by coughing, talking, and swallowing. Pain in glossopharyngeal neuralgia has a relapsing and remitting pattern. Vaso glossopharyngeal neuralgia may be associated with life-threatening cardiovascular features- syncope, hypotension, cardiac arrhythmias, in contrast to trigeminal neuralgia

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
None

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

入选标准

  • Age ≥ 18 and ≤ 70 Years.
  • Both sexes
  • American Society of Anesthesiologists (ASA) class II and III.
  • Patients under pain management for oropharyngeal cancer (failed medical treatment or intolerance to the side effects of the drug).
  • Visual analog scale (VAS) equal to or more than 6 cm in spite medical treatment.

排除标准

  • Patient refusal.
  • Patients with local or systemic sepsis.
  • Uncorrectable coagulopathy.
  • Unstable cardiovascular disease.
  • History of psychiatric and cognitive disorders.
  • Patients allergic to medication used.7
  • Unable to lie supine.
  • Local anatomical distortion (either congenital, post-surgical or post-radiotherapy) making intervention difficult and hazardous.
  • Elongated styloid process > 25 mm.
  • Age less than 18 year and more than 70 year.

结局指标

主要结局

The degree of pain

时间窗: 3 months after the procedure

Each patient will be instructed about pain assessment with the visual analog scale (VAS) score. VAS(0 represents "no pain" while 10 represents "the worst pain imaginable"). VAS score will be measured at the following times: pre-procedure, day 1 after the procedure, 1,2,3,4 Weeks after the procedure, 2,3 Months after the procedure.

次要结局

  • Patient satisfaction score(1 month after the block)
  • Morphine consumption(3 months after the procedure)
  • Gabapentin consumption(3 months after the procedure)
  • Percentage of functional improvement(1 month after the procedure)
  • Quality of life score(12 weeks after the procedure)

研究者

发起方
National Cancer Institute, Egypt
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hany Magdy Danial

Assistant Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine

National Cancer Institute, Egypt

研究点 (2)

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