Transnasal sphenopalatine ganglion block for post-dural puncture headache of moderate severity : an observer blind, parallel group randomized control trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Relief of Post dural puncture headache
研究概览
简要总结
70 patients will be randomly devided in to two different group: SP(N=35), SS (N=35) [SP=Sphenoealatine ganglion block ; SS=Sham block]
BP(SBP, DBP) Pulse Rate, VAS score will be studied at base line, 30 minutes, 4 hours, 24 hours, 48 hours after the procedure and by telephonic followup at 7th day.
For SPG block - Patients supine with sniffing position :- After visually inspecting each nostril two long cotton tipped applicators will be soaked in 2% lidocaine applied and advanced until resistance is met. The procedure will be repeated in the other nostril. The applicators will be left in place for 10 minutes and 1 ml of lidocaine reapplied through the canal of the applicator and kept for another 10 minutes, after that applicators will be removed.
For SS block :- same as the procedure of SPG block here 0.9% NS (Normal Saline) will be used instead of lidocaine.
Calculation of the study is based on anticipated difference in headache intensity scored by VAS at 48 hours following the block procedure. It is calculated that 35 patients would be required in order to detect difference of 20 mm in VAS score between groups with 80% power and 5% probability type 1 error. Sample size calculation has been done by "n Master 2.0" software (Dept. of Bio-statistics, Christian Medical College, Vellore 2011)
Study will be randomized to SPG block arm and the Sham block arm using the computer generated randomized list. Allocation concealment will be by serial number opaque sealed envelop [SNOSE] technique.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)(—)
- 性别
- Female
入选标准
- •All postpartum women aged 18-40 years who received Neuraxial anaesthesia for cesarean delivery and are diagnosed with a moderately severe post dural puncture headache within 48 hours post partum.
排除标准
- •History of Migraines and chronic headache.
- •Bleeding disorder.
- •Gross deformity or infection of the nasal septum, nasal polyp, nasal or sines surgery within the past year.
- •Chronic narcotic user.
- •Neurological disorder.
- •pregnancy induced hypertension.
- •Allergy to local anaesthetics.
结局指标
主要结局
Relief of Post dural puncture headache
时间窗: 30 minutes
次要结局
- Adverse effect of Drug(Immediate)
