The Effect of Ganglion Sphenopalatine Block (GSP-block) Versus Placebo on Postdural Puncture Headache: a Blinded Randomized Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 10
- 主要终点
- Hyperactivity in the sphenopalatine ganglion assessed by pain intensity (0-100mm on a visual analogue scale, VAS) of the postdural headache in standing position.
研究概览
简要总结
The purpose of this study is to evaluate the effect of the ganglion sphenopalatine block (GSP block) on postdural puncture headache.
详细描述
Adult patients with postdural puncture headache will be enrolled in the study. The patients will be randomised to receive a ganglion sphenopalatine block (GSP-block) with either local anesthetic (lidocaine + ropivacaine) or placebo (isotone NaCl).
Primary outcome is hyperactivity in the sphenopalatine ganglion assessed by pain intensity (0-100mm on a visual analogue scale, VAS) of the postdural headache in standing position 30 minutes after block.
If the patients in the timeframe of 1 hour to 1 week after block does not achieve remission (VAS <30mm while standing) they will be offered a "rescue GSP-block" defined as a new GSP-block with "open-label" local anesthetic and if continued lack of remission at least 1 hour thereafter then an epidural blood patch will be offered.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Age > 18 years
- •Patients with postdural puncture headache defined as moderate to severe postural headache (VAS >= 30mm) after lumbar puncture or accidental dural puncture during epidural insertion with an onset within 3 days following the puncture.
- •Lack of headache remission within 1 day after dural puncture and after treatment with fluids, caffeine and paracetamol
- •Patients who have given their written informed consent for participation in the study after fully understanding the protocol content and limitations.
排除标准
- •Patients who cannot cooperate to the study
- •Patients who does not understand or speak Danish
- •Allergy to the drugs used in the study
- •Has taken opioids within 12 hours prior to intervention
研究组 & 干预措施
Local anesthetic
干预措施: Ganglion sphenopalatine block with local anesthetic (Procedure)
Isotonic NaCl
干预措施: Ganglion sphenopalatine block with placebo (Procedure)
结局指标
主要结局
Hyperactivity in the sphenopalatine ganglion assessed by pain intensity (0-100mm on a visual analogue scale, VAS) of the postdural headache in standing position.
时间窗: 30 minutes after block
Pain intensity will be measured as worst experienced pain after the patient has been standing for 30 seconds or the worst experienced pain while attempting to stand if the rating has to be interrupted.
次要结局
- Number of patients with pain rating below 30mm in standing position (0-100mm on a visual analogue scale, VAS)(30 minutes after block)
- Number of patients needing "rescue GSP-block"(During study period until completion of 1 week follow up)
- Pain rating (0-100mm on a visual analogue scale, VAS) in supine position(30 minutes after block, 1 hour after block and 1 week after block)
- Pain rating (0-100mm on a visual analogue scale, VAS) in standing position(1 hour after block and 1 week after block)
- Number of patients needing a epidural blood patch(During study period until completion of 1 week follow up)
研究者
Mads Seit Jespersen
MD
University Hospital Bispebjerg and Frederiksberg