Sphenopalatine Ganglion Block for Treatment of Postdural Puncture Headache: A Prospective Randomized Double Blind Placebo Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- verbal pain score
研究概览
简要总结
The investigators are attempting to determine a less invasive method of treatment for postdural puncture headaches that can occur after regional anesthesia. The investigators will be evaluating the relief of headache with those subjects receiving treatment with a sphenopalatine ganglion block with bupivacaine versus placebo, evaluating the incidence of epidural blood patch, pain score of headache at 1 hour, then 24, 48, and 72 hours lower with post study treatment versus placebo, and potential side effects of those patients receiving study therapy as well as epidural blood patch.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists assigned class I-III
- •age >/= 18 years
- •experiencing a postdural puncture headache within 7 days of neuraxial analgesia rated >3/10 pain score
排除标准
- •allergy to study medications <18 years of age pain score on presentation </=3/10 for headache
研究组 & 干预措施
placebo
sphenopalatine ganglion block performed with normal saline as the placebo
干预措施: placebo (Drug)
bupivacaine
sphenopalatine ganglion block performed with bupivacaine
干预措施: bupivacaine (Drug)
结局指标
主要结局
verbal pain score
时间窗: 1 hour
a reduction in headache verbal pain score by 3
次要结局
- pain score(7 days)
- patient satisfaction(1 hour)
- epidural blood patch(7 days)