Comparison between Sphenopalatine ganglion block versus conservative management for postdural puncture headache in cesarean section
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- efficacy of sphenopalatine ganglion block and conservative measures in PDPH and objective is to compare the efficacy of sphenopalatine ganglion block and conservative treatment with respect to reduction in pain score.
研究概览
简要总结
The aim is comparing the efficacy of sphenopalatine ganglion block and conservative measures in PDPH and objective is to compare the efficacy of51 sphenopalatine ganglion block andconservative treatment with respect to reduction in pain score at 15 min, 60 min, 6-hour,12 hour and 24 hours in PDPH. In both the groups sphenopalatine ganglion block and conservative management will be given by my colleague in ward for patient of PDPH, after 5 min I am going to assess pain score.Patient will be assessed using NRS Numeric Pain Rating Scale 0-10
0-3 = no pain
3-7 = moderate pain
8-10 = worst possible
Pain score will be assessed at 15 min, 60 min, 6-hour,12 hour and 24 hours in both groups after an intervention and time at which NRS score declines will be considered as onset of analgesia in both the groups. At 15 min, 60 min, 6-hour, 12 hour and 24-hour vital parameters like BP, PR, SPO2 will be recorded. Along with pain, patients will be asked about the sensation of nausea and vomiting. After 6 hours if NRS score is >7 it means pain is not relieved, patient will be marked as a failure, then rescue therapy will be considered. Patients in both groups without pain relief after 24 h will be considered for Epidural blood patch.
Any adverse events that occur in study will be treated according to standard protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Double
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •Obstetric patient with diagnosed PDPH who underwent Lower segment caesarean section under subarachnoid block.
- •Age more than 18years.
排除标准
- •History of allergy to local anesthetic
- •Had opioid taken less than 12hrs before the study inclusion.
- •Preeclampsia, Eclampsia, chronic hypertension
- •Known coagulopathy.
- •Nasal septal deviation
- •Nasal polyp
- •History of nasal bleeding
- •Nasal and basal bone fracture.
结局指标
主要结局
efficacy of sphenopalatine ganglion block and conservative measures in PDPH and objective is to compare the efficacy of sphenopalatine ganglion block and conservative treatment with respect to reduction in pain score.
时间窗: 15 min, 60 min, 6-hour,12 hour and 24 hours.
次要结局
- 1.Onset of analgesia(2.Hemodynamic effects BP, PR, SpO2)
研究者
Dr Prema I Tondi
Kodagu Institute of Medical sciences