Effectiveness of Sphenopalatine Ganglion Block for Post-Dural Puncture Headache; A Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Pain Score at Baseline
研究概览
简要总结
The objective of the study is to determine the effectiveness of Spheno-Palatine (SP) ganglion block to alleviate the pain of post-dural puncture headache (PDPH).
详细描述
The primary objectives of the study are to study the effectiveness of SP ganglion block in relieving post-dural puncture headache in terms of :
- Number of subjects who get relief of pain
- The onset time to pain relief after application of block
- The duration of pain relief
- The incidence of recurrence of post-dural puncture headache
Secondary objectives are to:
- Monitor any complications due to SP ganglion block
- Measure patient satisfaction
- Monitor any residual effects at 1 months after the SP block
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Complains of symptoms suggestive of post-dural puncture headache
- •Has a history of dural puncture (lumbar puncture or accidental dural puncture during epidural placement) within the previous 7 days
- •Fluent in written and spoken English
排除标准
- •Those with a known history of hypersensitivity to local anesthetics of the amide type or to other components of GLYDO
- •Those with any congenital or acquired, anatomical deformity of the nostril, which preclude performing the block
- •Those who refuse to consent to participate in the study
- •Patients who have had a failed epidural blood patch
- •Cognitive Impairment
研究组 & 干预措施
Sphenopalatine ganglion block
Sphenopalatine ganglion block: this block will be performed by inserting swabs, with lidocaine squirted on them, into each nostril and reaching the nasopharyngeal wall.
干预措施: Lidocaine (Drug)
结局指标
主要结局
Pain Score at Baseline
时间窗: 15 minutes before the SP block
Pain scores will be recorded at Baseline in a sitting position. Pain scores will be quantified using the Visual analog pain (VAS) scale. The visual analog scale (VAS) is a tool widely used to measure pain. The scale range is 0-10 with 0 being no pain and 10 being severe pain.
Pain Score 60 Minutes Post-SP Block
时间窗: 60 minutes
Pain scores will be recorded 60 minutes post-SP block in a sitting position. Pain scores will be quantified using the Visual analog pain (VAS) scale. The visual analog scale (VAS) is a tool widely used to measure pain. The scale range is 0-10 with 0 being no pain and 10 being severe pain.
Pain Score 1 Day Post-SP Block
时间窗: 1 day
Patient reported pain scores will be recorded day 1 post SP block in a sitting position. Pain scores will be quantified using the Visual analog pain (VAS) scale. The visual analog scale (VAS) is a tool widely used to measure pain. The scale range is 0-10 with 0 being no pain and 10 being severe pain.
Pain Score 2 Days Post-SP Block
时间窗: 2 days
Patient reported pain scores will be recorded day 2 post SP block in a sitting position. Pain scores will be quantified using the Visual analog pain (VAS) scale. The visual analog scale (VAS) is a tool widely used to measure pain. The scale range is 0-10 with 0 being no pain and 10 being severe pain.
Pain Score 7 Days Post-SP Block
时间窗: 7 days
Patient reported pain scores will be recorded day 7 post SP block in a sitting position. Pain scores will be quantified using the Visual analog pain (VAS) scale. The visual analog scale (VAS) is a tool widely used to measure pain. The scale range is 0-10 with 0 being no pain and 10 being severe pain.
Pain Score 30 Day Post-SP Block
时间窗: 30 days
Patient reported pain scores will be recorded day 30 post SP block in a sitting position. Pain scores will be quantified using the Visual analog pain (VAS) scale. The visual analog scale (VAS) is a tool widely used to measure pain. The scale range is 0-10 with 0 being no pain and 10 being severe pain.
次要结局
- Duration of Pain Relief(24 hours)
- Number of Participants With Recurrence of Post-dural Puncture Headache(7 days)
- Number of Participants With Complications Due to SP Ganglion Block(15 minutes before the SP block to 30 days post SP block)
研究者
Verghese T Cherian, MD
Associate Professor of Anesthesiology & Perioperative Medicine
Milton S. Hershey Medical Center