Effect of Superior Cervical Sympathetic Block Versus Stellate Ganglion Block to Treat Cerebral Vasospasm in Patients With Refractory Post-traumatic Subarachnoid Hemorrhage.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- TCD velocities
研究概览
简要总结
Posttraumatic Subarachnoid hemorrhage (SAH) is a life-threatening neurological problem with a high mortality rate. Delayed cerebral ischemia (DCI) is the second-leading cause of death and disability in patients suffering from SAH. DCI is strongly associated with cerebral arterial vasospasm (CAV), which reduces cerebral blood flow (CBF) and causes cerebral infarction.
Various treatment modalities have been tried for the prevention and treatment of vasospasm, including oral nimodipine and isovolumic hypertension, as well as endovascular treatments such as intra-arterial drug infusion and balloon angioplasty. A few studies have demonstrated the role of stellate ganglion block (SGB) in the management of this dreaded complication.
Cervical sympathetic block (CSB) may be an effective therapy but is not routinely performed to treat vasospasm/DCI. CSB is a local, minimally invasive, low cost and safe technique that can be performed at the bedside and may offer significant advantages as complementary treatment in combination with more conventional neurointerventional surgery interventions.
Aim of study is evaluating the effect of superior sympathetic ganglion block versus stellate ganglion block in treating cerebral vasospasm and prevention of delayed cerebral ischemia in refractory post-traumatic subarachnoid hemorrhage.
详细描述
Trauma patients with CT evidence of post-traumatic SAH will be enrolled in the study and randomly assigned into two groups (30 patients each):
- Group A: Superior cervical ganglion block group (CSB); 5 ml bupivacaine 0.5% will be injected around the internal carotid artery at the level of carotid bifurcation on the side of spasm and on each side if bilateral spasm using USG.
- Group B: Stellate ganglion block group (SGB); 5 ml bupivacaine 0.5% will be injected between the common carotid artery and longus capitis muscle at the level of C7 vertebra on the side of spasm and on each side if bilateral spasm using USG.
All patients will be treated with a standardized protocol that included immediate intensive care monitoring, hypertension (MABP < 90 mmHg) and avoidance of hypotensive events, fluid resuscitation to maintain hypervolemia (defined as a positive fluid balance >500 mL/d), and spontaneous hemodilution at 0.3 hematocrit. All patients will receive oral nimodipine for 3 weeks. Analgesia as needed and sedation will be avoided if possible.
Intervention Technique:
- Superior cervical ganglion block technique;
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Trible masking (participant, care provider and outcomes assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Trauma patient with radiological evidence of refractory SAH despite adequate pharmacological treatment; TCD velocity > 120 cm/sec.
- •Trauma Patients with clinicoradiological evidence of cerebral vasospasm. The clinical criteria is new onset of neurological impairment such as hemiparesis, aphasia, hemianopia, or decrease of at least 2 points on the GCS not explained by appearance of new finding in follow up CT.
- •Age 18-65 will be included in the study
- •Both sex are included .
排除标准
- •Refusal to consent participating research from patient or his guardian.
- •Patients with deterioration in the level of consciousness due to other causes such as rebleeding, infarct, hydrocephalus, cerebral edema, infection, electrolyte disorder, or seizure.
- •Trauma and local infection in the nerve block area.
- •Coagulopathy.
研究组 & 干预措施
Superior cervical ganglion block group (CSB)
standardized protocol + CSB
干预措施: Superior cervical sympathetic block group (Procedure)
Stellate ganglion block group (SGB)
standardized protocol + SGB
干预措施: Stellate ganglion block group (Procedure)
结局指标
主要结局
TCD velocities
时间窗: 24 hours
changes in transcranial Doppler (TCD) velocities of middle cerebral artery (MCA) before and after block.
次要结局
- Technical complications(24 hours)
- GCS(24 hours)
- New vasospasm(24 hours)
研究者
Rabab Ahmed Samy Anwer
Principal investigator
Assiut University