Changes in Cerebral Blood Flow (CBF) in Prone and Sitting Position Before and After GSP-block and Before and After Epidural Blood-patch: A Substudy of NCT03652714
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Comparison of paint rating (0-100 on a visual analogue scale, VAS) and Cerebral Blood Flow velocity (CBF) before and after each intervention.
研究概览
简要总结
The purpose of this optional sub-study to GSPB-2018 (NCT03652714) is to evaluate the changes in cerebral blood flow (CBF) under different conditions to understand if postdural puncture headache is caused by changes in the cerebral blood flow and if treatment normalises that change.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- •Study Population:
- •Subjects who have consented to participate in GSPB-2018 will be approached for participation in this sub-study. Subjects who have consented to participate in GSPB-2018 are not required to participate in this sub-study.
- •Inclusion Criteria:
- •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 and substudy 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
- •No possible transcranial window on transcranial doppler. If not possible to find a useable window to get measurement the patient will be excluded and replaced with another patient.
研究组 & 干预措施
Isotonic NaCl
干预措施: Ganglion sphenopalatine block with placebo administered on study GSPB-2018 (Procedure)
Local anesthetic
干预措施: Ganglion sphenopalatine block with local anesthetic administered on study GSPB-2018 (Procedure)
结局指标
主要结局
Comparison of paint rating (0-100 on a visual analogue scale, VAS) and Cerebral Blood Flow velocity (CBF) before and after each intervention.
时间窗: <1h before and 1 hour after each intervention
Pain intensity measured with a pain rating (0-100mm on a visual analogue scale, VAS) in supine position and as worst experienced pain after the patient has been upright for 30 seconds or the worst experienced pain while attempting to stand if the rating has to be interrupted. Cerebral Blood Flow velocity (CBF) measured as mean blood flow in cm/sec.
Change in Cerebral Blood Flow velcity (CBF) in supine versus upright position compared to effect of treatment.
时间窗: <1h before and 1 hour after each intervention
Change in mean, minimum and maximum Cerebral Blood Flow velcity in cm/sec (CBF) in supine versus upright position compared to effect of treatment.
次要结局
- Change in Cerebral Blood Flow velocity (CBF) in supine position before and after interventions.(<1h before and 1 hour after each intervention)
研究者
Mads Seit Jespersen
Medical Doctor, Primary Investigator
University Hospital Bispebjerg and Frederiksberg