Stellate Ganglion Block and Cerebral Vasospasm (BLOCK-CVS)

Capital Medical University

Status: Enrolling

Conditions: Stellate Ganglion Block; Aneurysmal Subarachnoid Hemorrhage; Cerebral Vasospasm

Treatments: Procedure: Stellate ganglion block

Study type: Interventional

Funder types: Other

Identifiers

NCT04691271

Z191100006619068

Details and patient eligibility

About

At present, cerebral vasospasm (cVS) is the main cause of delayed cerebral infarction (DCI), which leads to high disability and mortality rate after aneurysmal subarachnoid hemorrhage. As a consequence, the key of reducing DCI is to prevent cVS. But unfortunately, despite years of efforts, the prevention and treatment of cVS is still a major clinical dilemma and various ways of treatment are still being explored. Recent studies have shown that stellate ganglion block (SGB) can dilate cerebral vessels and alleviate the impact of existing cVS. However, there is no study to evaluate the effect of early application of SGB on the improvement and prevention of cVS after aSAH.

Full description

Cerebral vasospasm refers to the extensive segmental or diffuse contraction of cerebral vasculature after aSAH, and cerebral blood flow is significantly reduced, which can lead to delayed cerebral ischemia (DCI) or delayed ischemic neurological dysfunction (DIND). Past studies have shown that if cerebral vasospasm occurs in patients with aSAH, the proportion of ischemic brain injury can be as high as 20%-30%.Obviously, prevention and treatment of CVS are the key to reducing the disability and mortality of aSAH.

Enrollment: 202 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age range: 18-65 years old;
• Within 48 hours after onset of aSAH,and planning surgical treatment(aneurysm clipping);
• Preoperative Hunt-Hess grade 2-3
• Sign informed consent.

Exclusion criteria

• ASA > grade III;
• Patients with posterior circulation aneurysm, ophthalmic aneurysms or internal carotid aneurysms;
• patients with multiple aneurysms;
• Patients with severe coagulation dysfunction;
• Patients with trauma and local infection in the nerve block area;
• Local anatomic structure changes (neck structure changes caused by radiotherapy, chemotherapy and surgery);
• MCA stenosis or infarction was found by preoperative imaging;
• Patients with poor temporal window signal revealed by preoperative TCD (clear waveform image could not be obtained);
• Allergy to known local anesthetics;
• Pregnant and lactating women.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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202 participants in 2 patient groups

Intervention group

Experimental group

Description:

In addition to routine anesthesia management and surgical operations, a stellate ganglion block was performed before induction of anesthesia, and then receive standard care after operation. Related statistical indicators were collected prospectively.

Treatment:

Procedure: Stellate ganglion block

Blank control group

No Intervention group

Description:

In this study, a blank control was used. Routine anesthesia management and surgical operation were used without any special interventions(only an camouflaging action), and then receive standard care after operation. Only relevant statistical indicators were collected prospectively.