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临床试验/CTRI/2024/02/062486
CTRI/2024/02/062486已完成不适用

Evaluation of Ultrasound guided Glossopharyngeal Nerve Block Technique

Sanjay Gandhi Post-graduate Institute of Medical Sciences1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2024年2月14日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
25
试验地点
1
主要终点
SEVERITY OF PAIN

研究概览

简要总结

Title: Evaluation of Ultrasound Guided Glossopharyngeal Nerve Block Technique Glossopharyngeal

neuralgia, also known as vagal glossopharyngeal neuralgia, is characterized by intermittent episodes

of shooting sharp pain in the jaw, throat, tongue, and ear that fall within the sensory distribution of

the glossopharyngeal nerve (cranial nerve IX) Inclusion criteria: Patients (more than 18 years of age)

diagnosed with primary glossopharyngeal neuralgia not responding to medical management will be

included in the present study. Exclusion criteria: 1. Patients with cardiopulmonary diseases such as

myocardial infarction, and heart failure 2. Patients with mental disorders, local infection, or

pregnancy 3. Patients with abnormal coagulation function 4. Patients with history of snoring.

POSITION- Patient lying in the lateral position with a thin pillow under the head. Area between

mastoid process and angle of mandible will be scanned with high-frequency (13-6 MHz) linear array

hockey stick probe to locate styloid process. Colour flow dopler will be used to identify the internal

carotid artery and the internal jugular vein. A needle will be directed in an in plane approach

towards the styloid process; which will be hit and the needle slid posteriorly and 2 ml 1% lidocaine +

4 mg dexamethasone injected.Positive response - > 50% reduction NRS scores for at least 2 hours

following injection; patients having a positive response will be followed for 6 months.A combination

of acetaminophen (325mg) and tramadol (37.5mg) will be prescribed for 5 days post-procedure and

patient advised to take the same if NRS will be >3 and on SOS basis during follow up. Repeat block

will be performed if severity of pain increased to NRS of > 5 or pain relief decreased to less than

50%. PRIMARY Severity of pain on the basis of NRS Score SECONDARY Percentage pain relief

Reduction of analgesic usage, and psychological assessment of patient by using DSM-IV scale All

these assessments will be done before the procedure (baseline), 2 hours after the procedure, 2

weeks, 1, 3- and 6-months post-procedure; the patient assessment between 2 weeks to 6 months of

follow up will be done by telephonic communication SAMPLE SIZE- Using Wilcoxon signed rank test

(matched pair) for one tail (as score will reduce) and effect size 1, 15 cases are required.

Considering design effect (1.5) and 10% lost to follow up final sample size will be 25. STATYSTICAL

ANALYSIS- Paired t-test will be used to compare pre and post-treatment results of NRS scores;

McNemar test will be used to compare pre and post- treatment results of percentage pain relief and

reduction of analgesic dose; Wilcoxon signed rank test will be used for the comparison of DSM-IV; P

value < 0.05 will be considered as significant.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients diagnosed with primary glossopharyngeal neuralgia not responding to medical management will be included in the present study.

排除标准

  • Patients with cardiopulmonary diseases such as myocardial infarction, and heart failure
  • Patients with mental disorders, local infection, or pregnancy
  • Patients with abnormal coagulation function
  • Patients with history of snoring.

结局指标

主要结局

SEVERITY OF PAIN

时间窗: Baseline, 2 hours after the procedure, 2 weeks, 1, 3- and 6-months post-procedure

次要结局

  • Percentage pain relief(Baseline, 2 hours after the procedure, 2 weeks, 1, 3- and 6-months post-procedure)
  • Reduction of analgesic usage(Baseline, 2 hours after the procedure, 2 weeks, 1, 3- and 6-months post-procedure)
  • Psychological assessment of patient by using DSM-IV scale(Baseline, 2 hours after the procedure, 2 weeks, 1, 3- and 6-months post-procedure)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Sujeet Kumar Singh Gautam

Sanjay Gandhi Post-graduate Institute of Medical Sciences

研究点 (1)

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