Verification of Sphenopalatine Ganglion Block Success Using Transcranial Doppler in Management of Patients With Post Dural Puncture Headache
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- pain changes assessment by numeric rating scale (NRS)
研究概览
简要总结
This study aims to investigate the ability of SPGB in the management of PDPH. Transcranial Doppler is also used as an measure to assess the block success by detecting the variability in the cerebral hemodynamics before and after the block.
详细描述
This clinical trial is performed in postoperative orthopedic unit. In this study, 120 patients were enrolled who had an epidural anesthesia; 60 patients who developed PDPH joined the treatment group (A) and received the SP block. They are assessed before the procedure by NRS and at 30 mins, 2h, 4h, 6h, 12h, and 24h after the procedure. Patients are also assessed by TCD before and after the block. The control group (B) included 60 patients with no PDPH.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Outcomes Assessor)
盲法说明
Double (Care Providor, Outcome Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients are considered who had an epidural anesthesia
- •Patients with ASA 1 and 2
- •Patients' age ranged from 18 to 60 years.
排除标准
- •Patients with septal perforation, nasal septum deviation,or nasal bleeding.
- •Patients have recent nasal trauma
- •Patients have recent nasal surgery
- •Patients have a nasal infection
- •Patients within ASA 3 and 4
- •Patients older than sixty yrs or younger than eighteen yrs.
研究组 & 干预措施
the treatment group (A)
Patients who have PDPH are manged by SPGB, they are assessed by NRS before the block, at 30 mins, 2h, 4h, 6h, 12h, and 24hours after block. The patients are also examined by TCD before and after the block.
干预措施: Sphenopalatine Ganglion Block using 2% lidocaine (Drug)
control group (B)
The control group (B) of 60 patients with no PDPH were examined by TCD
干预措施: Sphenopalatine Ganglion Block using 2% lidocaine (Drug)
结局指标
主要结局
pain changes assessment by numeric rating scale (NRS)
时间窗: Before the block and at 30 minutes, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, and 24 hours after the block
Pain score changes are assessed before and after the block using NRS in which zero is no pain and ten is worst pain imagined. pain was assessed throughout 24 hours after performing the block and Pain relief is considered when NRS ≤ 4.
次要结局
- Detecting the changes in cerebral vessels caliber after doing SPGB(TCD measurements are performed before SPGB is given to both groups, it is repeated again within an hour after the block for group (A) only.)
研究者
Naglaa Fathy Abdelhaleem Abdelhaleem
Lecturer, Anesthesia and Surgical Intensive Care department, Faculty of Medicine
Zagazig University