Comparison of Sphenopalatine ganglion block efficacy via transnasal approach using lignocaine , lignocaine with dexamethasone versus placebo in patients of trigeminal neuralgia refractory to pharmacotherapy- A Prospective Randomized control trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 72
- 试验地点
- 1
研究概览
简要总结
Patient will be randomized using SNOSE technique (Sequentially numbered opaque sealed envdelopes) into following three groups
Group L Sphenopalatine ganglion block( SPG) via transnasal approach using 2 ml lignocaine 4 percent and 1 ml normal saline
Group D SPG block with lignocaine 4 percent and 4 mg dexamethasone 1 ml
Group C Placebo group that is 3 ml normal saline
Patient will be assessed at 15 mins 30 mins 1 hour 6 hours 12 hours 24 hours 36 hours 48 hours and at discharge for pain score (NRS score) blood pressure pulse rate spo2 and any adverse events .
In case of NRS more than 4 rescue analgesia will be administered to all groups
Frequency of attacks per day will be recorded 12 hourly till discharge
Patients follow up will be done at 1 week interval for next 2 weeks and will be asked to maintain pain diary and continue their medical therapy they are on.
In case of no improvement in pain score patient will be send for standard therapy
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosed case of trigeminal neuralgia refractory to pharmacotherapy having severe pain belonging to ASA physical status I-III.
排除标准
- •1.Patients undergone previous treatment with Radiofrequency ablation.
- •2.Any diagnosed/known vascular lesion and anatomical deformity of nose or fracture on affected side.
- •Active nasal discharge.
- •Patients with any other painful conditions for which patients is on analgesic medication.
- •5.pregnant and lactating females.
研究者
Dr Kritika Mani
Institute of Medical Sciences (IMS),Banaras Hindu University (BHU)