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临床试验/NCT05925478
NCT05925478已完成早期 1 期

Pterygopalatine Fossa Block in Aneurysmal Subarachnoid Hemorrhage

University of Texas Southwestern Medical Center1 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2023年11月6日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
已完成
入组人数
2
试验地点
1
主要终点
Opioid consumption

研究概览

简要总结

Aneurysmal subarachnoid hemorrhage (aSAH) can cause a severe headache (HA) that is famously treatment-resistant. Current pain regimens are too reliant on opioids, which results in long-term opioid dependence and can obfuscate the neurological examination, which is critical to detect vasospasm and delayed cerebral ischemia. This study will gather the initial evidence of whether the pterygopalatine fossa (PPF) regional anesthesia nerve block can treat aSAH-related HA and reduce opioid consumption in patients with aSAH.

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

  • Aneurysmal subarachnoid hemorrhage with secured aneurysm
  • Age greater than or equal to 18 years
  • Able to communicate pain level

排除标准

  • Documented allergy to local anesthetics (e.g. bupivicaine)
  • Patients with unsecured aneurysms
  • Patients who are unable to communicate pain level (e.g. sedation/mechanical ventilation/delirium, etc)
  • Medical treatment for vasospasm including blood pressure/inotropic augmentation
  • Angiographic treatment for vasospasm within 48 hours

研究组 & 干预措施

Treatment arm

Experimental

干预措施: Bupivacaine 0.25% Injectable Solution (Drug)

Treatment arm

Experimental

干预措施: Ptergyopalatine Fossa Block (Procedure)

结局指标

主要结局

Opioid consumption

时间窗: 3 days

Pain Rating Scale

时间窗: 3 days

Scale of 1-10, 1 being lowest possible pain, 10 being highest possible pain

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Noah Jouett

Fellow Physician

University of Texas Southwestern Medical Center

研究点 (1)

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