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临床试验/CTRI/2016/08/007179
CTRI/2016/08/007179已完成不适用

Efficacy of pulsed radiofrequency ablation for the treatment of oarl cancer pain involving glossopharyngeal nerve.

Post Graduate Institute of Medical Education Research1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2014年9月24日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Efficacy of PRF ablation of glossopharyngeal nerve for the treatment of cancer pain by pain score by numerical rating scale

研究概览

简要总结

The Pulsed Radiofrequency (PRF)  treatment has been used previously for the treatment of various pain conditions and found to be safe & effective.In this trial we will study whether PRF treatment of glossopharyngeal nerve is effective & safe in the pain management of oropharyngeal cancer patient suffering from intractable pain which can not be controlled by traditional analgesic therapy at base of tongue, tonsillar fossa, oropharynx( area supplied by glossopharyngeal nerve). PRF of glossopharyngeal nerve will be done at Operation theatre under full aseptic precaution with standard monitoring for vital signs & as day care basis. Post procedure patient will be monitored at PACU for 2 hrs and subsequently patient will be assessed at 1 week, 2week. 1 month, 2 month, 3 month post PRF at pain clinic. During their visit pain score will be noted according to numerical rating scale ( NRS). Treatment will be considered effective if there is 50% reduction in NRS at 2 week post PRF from the base line.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Open Label

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Adult population (18-65 years)suffering from oropharyngeal carcinoma with no curative intervention planned( not fit for surgery) undergoing treatment by WHO step ladder II method still complaining of severe pain ( NRS>5) in the base of tongue, tonsillar fossa, pharynx- area mainly supplied by glossopharyngeal nerve.

排除标准

  • unstable cardio-respiratory disorder coagulation & hematological disorder psychological disorder & history drug abuse non compliant for 3 months follow up injection site not suitable due to presence of infection , lymph node enlaegement bilateral involvement of glossopharyngeal nerve.

结局指标

主要结局

Efficacy of PRF ablation of glossopharyngeal nerve for the treatment of cancer pain by pain score by numerical rating scale

时间窗: Post intervention - 1week, 2 week, 1 month, 2 month, 3 month

次要结局

  • Safety profile of PRF of glossopharyngeal nerve in cancer pain(during & post intervention (120 mins ) & post intervention 1 week, 2 week, 1 month, 2 month,3 month)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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