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临床试验/NCT02365909
NCT02365909终止早期 1 期

A Prospective Randomized Double-Blind Placebo Controlled Study Evaluating Sphenopalatine Ganglion Block (SPGB) for Treatment of Postdural Puncture Headache (PDPH)

University of Arkansas1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2015年6月29日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
终止
入组人数
6
试验地点
1
主要终点
Headache verbal pain score

研究概览

简要总结

Postdural puncture headaches (PDPH) are a consequence of spinal and epidural anesthesia in approximately 1% of cases when performed in obstetric patients. The gold standard treatment for a PDPH is currently an epidural blood patch (EBP), which involves placing a needle back into the epidural space of the neuraxium and then injecting 20 ml of the patient's own blood through the needle and into the epidural space to form a clot over the insult in the tissue layer that causes the headaches. The investigators want to test the efficacy of using a less invasive procedure, called a sphenopalatine block (SPGB), for treatment of PDPH. SPGB has been used for many years in the treatment of migraines and cluster headaches, and there are several case reports of its use to successfully treat PDPH as well. SPGB simply involves applying a local anesthetic to the mucosa in the back of each nostril to numb the nerves that cause the headache. The investigators hope that the SPGB will reduce the number of PDPH patients that require and EBP.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Acitve

Active Comparator

This group will receive 0.3 ml of 0.5% bupivacaine per nare, applied with the Tx360®

干预措施: 0.5% bupivacaine (Drug)

Placebo

Placebo Comparator

This group will receive 0.3 ml of normal saline per nare, applied with the Tx360®

干预措施: normal saline (Drug)

结局指标

主要结局

Headache verbal pain score

时间窗: 1 hour

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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