A Comparison of the Efficacy of Sphenopalatine Ganglion (SPG) Block With 5% Lidocaine Versus Epidural Blood Patch (EBP) for the Treatment of Post-Dural Puncture Headache (PDPH)
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Number of Headaches With a VAS Score >8/10 Prior to Initiation of Either Therapy
研究概览
简要总结
The purpose of this study is to compare a pain block in the midface, versus the traditional, more invasive, therapeutic epidural patch for the treatment of headaches
详细描述
The sphenopalatine nerve block has been used to treat headaches. Patients have headaches after epidural access from post dural puncture. We need to know if sphenopalatine nerve block will help the patient with the headache.
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
- None
入排标准
- 年龄范围
- 13 Years 至 92 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females ages 13-92
- •Subjects have medical diagnosis of PDPH and require treatment
- •Subjects who signed consent/assent
排除标准
- •<13 years of age
- •Pregnancy
- •Subjects with heart failure
- •Subjects already being treated with lidocaine patch or other vehicle for chronic pain
- •Non-english speaking subjects
- •Subjects with platelets <100,000
- •Subjects that are septic
- •Subjects with an allergy to lidocaine
- •Subjects with known nasal polyps
- •Subjects with recent neurological event
- •Subjects on anticoagulant therapy
- •Subjects that received prior therapy with SPG block or EBP
研究组 & 干预措施
Epidural blood patch
20ml of sterile blood is obtained from the patients arm and placed in the epidural space using standard sterile epidural access.
干预措施: Epidural Blood Patch (Device)
Sphenopalatine Ganglion Block
Cotton tip applicators are used to deliver lidocaine to the posterior nares in the area of skin overlying the Sphenopalatine gangion
干预措施: Sphenopalatine Ganglion Block (Drug)
结局指标
主要结局
Number of Headaches With a VAS Score >8/10 Prior to Initiation of Either Therapy
时间窗: Prior to initiation of therapy (Epidural blood patch vs Sphenopalatine Ganglion Block).
Outcome measure will entail recording patient self-reported pain scores to quantify the level of headache pain using the Visual analog scale, meaning 0 - No pain, 1-3 - Mild Pain, 4-6 - Moderate Pain, 7-10 - Severe Pain, by way of in person assessment by pain questionnaire just prior to initiation of either therapy (Epidural blood patch vs Sphenopalatine Ganglion Block).
Number of Participants With a Headache Vas 8/10 at 30 Minutes Following Either Therapy.
时间窗: At 30 minutes following either therapy.
Self-reported pain scores to quantify the level of headache pain using the Visual analog scale (as defined within the description of outcome 1 above) by way of in person assessment by pain questionnaire at 30 minutes following either therapy (Epidural blood patch vs Sphenopalatine Ganglion Block).
Number of Participants With a Headache Vas 8/10 at 60 Minutes Following Either Therapy.
时间窗: At 60 minutes following either therapy.
Self-reported pain scores to quantify the level of headache pain using the Visual analog scale (as defined within the description of outcome 1 above) by way of in person assessment by pain questionnaire at 60 minutes following either therapy (Epidural blood patch vs Sphenopalatine Ganglion Block).
次要结局
未报告次要终点
研究者
William Grubb, M.D.
Clinical Associate Professor, Anesthesia
Rutgers, The State University of New Jersey