NCT04691271

Stellate Ganglion Block and Cerebral Vasospasm

Effect of Early Stellate Ganglion Block for Cerebral Vasospasm After Aneurysmal Subarachnoid Hemorrhage: a Randomized Controlled Trial (BLOCK-CVS)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 202 (estimated)
• Sponsor: Beijing Tiantan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Aneurysmal Subarachnoid Hemorrhage
• Stellate Ganglion Block
• Cerebral Vasospasm

Interventions

Type	Name	Description
PROCEDURE	Stellate ganglion block	After the patient entered the operating room, early SGB will be performed by a designated experienced anesthesiologist using the B-ultrasound visualization technique. The intervention site is the ipsilateral side of the planned craniotomy site. After routine disinfection, 0.5% ropivacaine 8-10 mL will be injected into the surface of the longus colli muscle on the medial side of the prevertebral fascia at the level of the C6 anterior tubercle, and then the puncture point will be covered with sterile dressings. The success criteria of e-SGB are Horner's syndrome, which is characterized by a miosis, ptosis, enophthalmos, conjunctival hyperemia and facial reddishness without sweating. For the "camouflaging" arm, the anesthesiologist only covered the corresponding part of the patient with sterile dressings to confuse the follow-up, without any puncture. All patients will be admitted to the ICU after the operation and then receive the standard of care.

Timeline

• Start date: 2021-07-01
• Primary completion: 2024-12-30
• Completion: 2024-12-30
• First posted: 2020-12-31
• Last updated: 2024-03-15

Locations

1 site across 1 country: China