Evaluation of the Efficacy of Sphenopalatine Block in Headache in Patients With Non-traumatic Subarachnoid Hemorrhage (SAH) After Training of Neurosurgical Intensive Care Nurses.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 主要终点
- Demonstrate a 50% change in morphine consumption with sphenopalatine ganglion block during the first 72 hours after cerebral arteriography
研究概览
简要总结
Non-traumatic SAH, linked in 85% of cases to the rupture of an intracranial aneurysm, is a serious stroke affecting young people. Half of all survivors suffer cognitive impairment. The presentation is that of a sudden-onset, isolated headache. This population is exposed to headache during hospitalization, which lasts an average of 13 days. This length of hospitalization is due to the fact that these patients must be monitored during the potential vasospasm period that occurs between days 4 and 14 after SAH. The pain associated with SAH is a source of discomfort and increased morphine consumption during the ICU stay, particularly during the first 10 days. Current recommendations call for conventional pain management with a combination of tier 1, 2 and/or 3 analgesics. For headache control, opioids are widely prescribed, sometimes in high doses, with adverse effects, despite efforts to reduce their use. Maximum headache pain scores remain high, indicating inadequate pain management. This highlights the urgent need to study alternative opioid-sparing and analgesia strategies for patients with SAH.
详细描述
Sphenopalatine block is already used for certain types of facial and cranial pain, and could help save morphine consumption during hospitalization. The sphenopalatine ganglion is a crossroads for parasympathetic, sympathetic and sensory pathways. Recently studied in post-puncture dural breaches with promising results, sphenopalatine ganglion block (SPGN) may appear as an interesting alternative therapy in the treatment of SAH headaches. Other advantages of this block are its simplicity, efficacy and the absence of any noticeable adverse effects at the time it is performed. What's more, it is already used routinely in our department, with rapid and effective action. The hypothesis of the trial would be to reduce morphine consumption by at least 50% for patients benefiting from BGSP, for better neurological monitoring and optimal overall pain management in SAH.
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
- Single (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
- •≥ 18 years
- •Non-traumatic SAH with or without aneurysm on brain imaging
- •WFNS score 1 and 2
- •Patient awake and extubated after radiological procedure
- •Patient in pain (EN > 3/10) despite usual level 1 analgesics (Paracetamol + Acupan)
- •Affiliated with or benefiting from a social security scheme
排除标准
- •Contraindication to sphenopalatine ganglion block (deviated nasal septum, repeated epistaxis, allergy to Lidocaine)
- •Patient unable to assess pain by EN
- •Persons covered by Articles L1121-5 to L1121-8 of the CSP and Articles 31 to 35 of Regulation 536/
- •Participation in other interventional research
- •Patient's refusal to participate
- •Arteriography more than 48 hours old
- •Inaugural headache lasting more than 48 hours
- •Presence of an unsecured vascular malformation at high risk of rupture
结局指标
主要结局
Demonstrate a 50% change in morphine consumption with sphenopalatine ganglion block during the first 72 hours after cerebral arteriography
时间窗: during 72 hours
Total morphine consumption in mg in the first 72 hours after cerebral arteriography in the Intensive care (ICU)
次要结局
- Demonstrate a significant 3-point change in pain on EN (Simple Numerical Scale)averaged over 7 days after arteriography(during 7 days)
- Describe morphine consumption per day during the patient's hospitalization for the 2 groups(during hospitalization or 10 days)
- Describe the complications associated with sphenopalatine ganglion block.(during 7 days)
- Evaluate the feasibility of the (BGSP) sphenopalatine ganglion block act performed by Ides(during 7 days)
- Demonstrate that the sphenopalatine ganglion block strategy changes headaches at 28 days.(at 28 days)
- Demonstrate that the sphenopalatine ganglion block strategy changes patient satisfaction at Day 28(at 28 days)
- Evaluation of nursing practices on the BGSP technique(up to 28 days)