Efficacy of Bilateral Greater Occipital Nerve Block as a Treatment for Headache Secondary to Spontaneous Subarachnoid Hemorrhage
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Composite variable consisting of headache reduction measured with the Numerical Pain Rating Scale (NPRS) at 1 hour post-procedure, defined as a ≥30% reduction (partial response) or ≥50% reduction (optimal effect) as dichotomous variables (yes/no; n, %), and/or the absence of headache within the first hour after the procedure.
研究概览
简要总结
To determine the efficacy of bilateral greater occipital nerve block in the management of headache pain related to SAH
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Patients with diffuse or perimesencephalic aSAH admitted to the Semicritical Care Unit or ICU of Hospital de la Santa Creu i Sant Pau.
- •Hunt and Hess scale 1-3 (see Annex 3).
- •Signed informed consent from the patient or their representative.
排除标准
- •Presence of other causes of secondary headache (AVM, space-occupying lesions, etc.).
- •Pregnancy or breastfeeding.
- •Cardiac conduction disorders: Second- or third-degree atrioventricular block. Arrhythmias with hemodynamic instability.
- •Convexity SAH.
- •Hunt and Hess scale 4 or 5 (see Annex 3).
- •History of allergic reaction to local anesthetic
- •Severe functional dependence (mRS 4-5, see Annex 7).
- •GCS ≤8 prior to the procedure (see Annex 4).
- •Intracranial surgery ≤1 month prior or planned during hospitalization (excluding ventricular drains).
- •Known terminal illness or imminent limitation of therapeutic effort.
- •Difficulty or foreseeable loss of clinical follow-up.
结局指标
主要结局
Composite variable consisting of headache reduction measured with the Numerical Pain Rating Scale (NPRS) at 1 hour post-procedure, defined as a ≥30% reduction (partial response) or ≥50% reduction (optimal effect) as dichotomous variables (yes/no; n, %), and/or the absence of headache within the first hour after the procedure.
Composite variable consisting of headache reduction measured with the Numerical Pain Rating Scale (NPRS) at 1 hour post-procedure, defined as a ≥30% reduction (partial response) or ≥50% reduction (optimal effect) as dichotomous variables (yes/no; n, %), and/or the absence of headache within the first hour after the procedure.
次要结局
未报告次要终点
研究者
Alejandra Espinosa
Scientific
Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau