Sphenopalatine Ganglion Block and Pain Management in Neurosurgery
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Visual Analogic Scale
研究概览
简要总结
Post craniotomy pain is defined as headache developed up to 7 days from a craniotomy, not otherwise explained. A moderate to severe pain affects from 60 to 84% of patients.
Sphenopalatine ganglion block has been successfully used in patients with chronic or acute headache, facial pain and for transsphenoidal pituitary and endoscopic sinus surgeries.
There are evidences that sphenopalatine ganglion block reduces vegetative responses to skull pin closure.
This study aim to investigate feasibility and efficacy of sphenopalatine ganglion block in reducing pain after a neurosurgical supratentorial craniotomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
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
- •supratentorial craniotomy
排除标准
- •prior craniofacial pain syndrome
- •drug assumption: pain-killers (chronic), antiepileptic
研究组 & 干预措施
Control
Troncular scalp blockade (Levobupivacaine 7,5%) Local site infiltration (Mepivacaine)
干预措施: Standard Preparation (Drug)
Treatment
Troncular scalp blockade (Levobupivacaine 7,5%) Local site infiltration (Mepivacaine) Transnasal sphenopalatine ganglion block (Levobupivacaine 7,5%)
干预措施: Sphenopalatine ganglion block (Drug)
Treatment
Troncular scalp blockade (Levobupivacaine 7,5%) Local site infiltration (Mepivacaine) Transnasal sphenopalatine ganglion block (Levobupivacaine 7,5%)
干预措施: Standard Preparation (Drug)
结局指标
主要结局
Visual Analogic Scale
时间窗: 180° day post-op
From 0 (no pain) to 10 (worst pain ever) on a straight line
Numerical Rating Scale
时间窗: 180° days post-op
From 0 (no pain) to 10 (worst pain ever)
Pain Assessment IN Advanced Dementia
时间窗: 180° day post-op
From 0 (no signs of pain) to 10 (Extreme pain)
次要结局
- Vegetative response (Heart rate)(1-5-10 min from skull pin closure. 1-5-10 min from skin incision)
- Adverse effect(Immediately post-op, 1°-2°-3°-4°-30°-60°180° days post-op)
- Vegetative response (Arterial pressure)(1-5-10 min from skull pin closure. 1-5-10 min from skin incision)