Stellate Ganglion Block and Cerebral Vasospasm

Aneurysmal Subarachnoid Hemorrhage Clinical Trial

— BLOCK-CVS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04691271
• Other study ID #: Z191100006619068
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: December 30, 2024

Study information

• Verified date: January 2024
• Source: Beijing Tiantan Hospital
• Contact: Ruquan Han, M.D., Ph.D
• Phone: 8610-59976660
• Email: ruquan.han[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 202
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aneurysmal Subarachnoid Hemorrhage
• Cerebral Vasospasm
• Ganglion Cysts
• Hemorrhage
• Stellate Ganglion Block
• Subarachnoid Hemorrhage
• Vasospasm, Intracranial

Intervention

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.

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of symptomatic vasospasm during hospitalization	Symptomatic vasospasm is defined as new focal or global neurological dysfunction or a decrease in the Glasgow coma score by more than 2 points, and with angiographic vasospasm on TCD or CTA.	an average of 2 weeks
Secondary	The incidence of TCD vasospasm during hospitalization	The mean blood flow velocity (MFV) of the middle cerebral artery = 120 cm/s or Lindegaard index (ratio of MFV of the middle cerebral artery to the internal carotid artery) = 3.	on the days 3-5 after operation
Secondary	The incidence of CTA vasospasm on the days 3-5 after operation	Compared with the preoperative baseline, the corresponding vessel diameter narrowed by more than 30% or new segmental stenosis occurred, not related to atherosclerosis or mechanical artery stenosis caused by arterial clamps or coils.	on the days 3-5 after operation
Secondary	The incidence of hypoperfusion in CTP diagnosis on the days 3-5 after operation	The incidence of hypoperfusion in CTP diagnosis	on the days 3-5 after operation
Secondary	The incidence of new cerebral infarction observed on the days 90 after operation and discharge .	New cerebral infarction is defined only as the appearance of new low-density infarct shadow on CT image compared with preoperation.	on the days 90 after operation and discharge
Secondary	The changes of he mean blood flow velocity (mBFV) after operation	the changes in the mean blood flow velocity (mBFV) of all large intracranial anterior circulation vessels	on the days 3-5 after operation
Secondary	Total length of stay in the intensive care unit and hospital.	Days	on the 90 days
Secondary	The modified Rankin scale at discharge, 30days, and 90 days	The modified Rankin scale =2 is defined as good prognosis	on the 30 and 90 days
Secondary	All-cause mortality rate up to 90 days.	The rate	on the 90 days
Secondary	Postoperative delirium incidence during hospitalization	The rate	on the days 1-3 after operation
Secondary	Postoperative cognitive dysfunction	The rate	At discharge,an average of 2 weeks
Secondary	The proportion of remedial treatment after CVS	The rate	At discharge,an average of 2 weeks
Secondary	Adverse events during hospitalization	Myocardial infarction, cardiac arrest, pulmonary embolism, infection, SGB related complications, etc	At discharge,an average of 2 weeks