Evaluation of Ultrasound guided Glossopharyngeal Nerve Block Technique
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
Dr Sujeet Kumar Singh Gautam
Sanjay Gandhi Post-graduate Institute of Medical Sciences
