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临床试验/NCT04331938
NCT04331938已完成1 期

The Efficacy of Landmark-guided Percutaneous Sphenopalatine Ganglion Block on Self-reported Headache Pain Secondary to Aneurysmal Subarachnoid Hemorrhage: A Feasibility Study

Mayo Clinic1 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2020年11月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
发起方
Mayo Clinic
入组人数
2
试验地点
1
主要终点
Reduction in patient reported pain using a standard numeric rating scale (NRS)

研究概览

简要总结

Researchers are trying to develop alternative means to help patients with headache pain secondary to aneurysmal subarachnoid hemorrhage (bleeding about the brain).

详细描述

This study is an open label, feasibility study that will consist of fifteen patients. This study will enroll only patients who have aneurysmal SAH that are secured by endovascular coiling. When a patient notes a severe headache which requires medical intervention on at least day 3 of the hospital admission, they will be asked if they would like to participate in an open label trial to use a bilateral SSPGB in addition to traditional medical management per unit protocol. The risks and benefits of the procedure will be explained to the patient. The patient will then either agree or disagree. If the patient disagrees, they will not be enrolled in the study. If the patient agrees, they will sign an informed consent and will be enrolled. Inclusion and exclusion criteria will be reviewed before enrolling a patient. The patients will first rate their pain from 0-10 on the numeric rating scale (NRS) (10 being the most severe). If their pain is at a level 5 or more and it is not responsive to traditional medical therapies, they will be a candidate for the study. The patients will receive bilateral injections as outlined below (5 mL: 4.5mL of 0.5% bupivacaine and 0.5mL of 10mg/mL dexamethasone on each side for total volume of 10 mL). Thirty minutes later and 24 hours following injection, the patient will rate their pain from 0-10 on the NRS. The description of the procedure is stated below. A success would be considered a drop in their pain score of at least 2.

Adverse effects will also be recorded 30 minutes after the procedure and the following day. Chart review on both provider and nursing notes will be performed on subsequent days to evaluate for adverse effects.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 and older
  • Aneurysmal SAH in anterior/middle cerebral compartment
  • Aneurysm must be secured endovascular with coiling
  • The patient or patient's surrogate should be able to give informed consent and understand the risks of this study
  • Pain NRS ≥ 5/10 in severity

排除标准

  • Non aneurysmal, traumatic SAH
  • Posterior fossa aneurysm ruptures
  • Pregnancy
  • Transcranial Doppler velocities suggestive of or approaching vasospasm

研究组 & 干预措施

Open Label Arm

Experimental

Patients will receive a 5mL injection comprised of 4.5mL 1% bupivacaine and 0.5mL of dexamethasone (10mg/mL) directed towards the sphenopalatine ganglion. This will be performed on both sides. Patients will be asked to rate their pain pre- and 30 minutes post-procedure on a scale of 0-10. Patients will also be asked to rate their nausea and photophobia on a similar scale. Patients will be reevaluated at 24 hours and 48 hours post procedure.

干预措施: Regional anesthetic SPG block-bilateral (Drug)

结局指标

主要结局

Reduction in patient reported pain using a standard numeric rating scale (NRS)

时间窗: 1 Day

A combination of Bupivacaine 0.5% 4.5mL along with Dexamethasone 10mg/mL 0.5mL will be injected toward the sphenopalatine ganglion using a suprazygomatic approach bilaterally

次要结局

未报告次要终点

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Narayan R. Kissoon

Principal Investigator

Mayo Clinic

研究点 (1)

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