The Effect of Ganglion Sphenopalatine Block (GSP-block) Versus Placebo on Postdural Puncture Headache: Follow Up
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Average pain score
研究概览
简要总结
The purpose of this study is to evaluate the long term effects of the ganglion sphenopalatine block (GSP block) on postdural puncture headache.
详细描述
Adult patients with postdural puncture headache was enrolled in main study (NCT03652714). In the main study the patients was randomised to receive a ganglion sphenopalatine block (GSP-block) with either local anesthetic (lidocaine + ropivacaine) or placebo (isotone NaCl).
Following inclusion in the main study all participants are sent a follow-up questionnaire.
Primary outcome is disability due to headache defined as moderate to severe disability measured with Migraine Disability Assessment Test (MIDAS) in the 3 months following initial block and average pain score in the 3 months following the initial block on a 0-10 pain intensity scale.
Secondary outcome is disability due to headache defined as moderate to severe disability measured with Migraine Disability Assessment Test (MIDAS) in the 3 previous months as well as average pain scores in the previous 3 months, days with headache and long and short term side effects of the block.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 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
结局指标
主要结局
Average pain score
时间窗: 3 months following initial block
Average pain score measured on a 0-10 pain rating scale (VAS) with 0 meaning no pain and 10 being the worst pain imaginable.
Migraine Disability Assessment Test score
时间窗: 3 months following initial block
Disability due to headache defined as moderate to severe disability measured with Migraine Disability Assessment Test Score (MIDAS) ranging from no disability at a score of 0 to severe disability at a score of 21+
次要结局
- Days with headache(3 months following initial block as well as the last 3 months)
- Migraine Disability Assessment Test score(3 previous months)
- Average pain score(3 previous months)
- Long term side effects(From date of initial block application until time of questionaire and inclusion in follow up study, assessed up to 60 months.)
- Short term side effects(From date of initial block application until time of questionaire and inclusion in follow up study, assessed up to 60 months.)
研究者
Mads Seit Jespersen
Principal Investigator
University Hospital Bispebjerg and Frederiksberg