Clinical trial NCT04691271: Stellate Ganglion Block and Cerebral Vasospasm
Official title: Effect of Early Stellate Ganglion Block for Cerebral Vasospasm After Aneurysmal Subarachnoid Hemorrhage: a Randomized Controlled Trial (BLOCK-CVS)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aneurysmal Subarachnoid Hemorrhage
Stellate Ganglion Block
Cerebral Vasospasm
Keywords: Cerebral vasospasm
Stellate ganglion block
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2020-12-31
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The incidence of symptomatic vasospasm during hospitalization
timeFrame: an average of 2 weeks
Secondary outcomes:
measure: The incidence of TCD vasospasm during hospitalization
timeFrame: on the days 3-5 after operation
measure: The incidence of CTA vasospasm on the days 3-5 after operation
timeFrame: on the days 3-5 after operation
measure: The incidence of hypoperfusion in CTP diagnosis on the days 3-5 after operation
timeFrame: on the days 3-5 after operation
measure: The incidence of new cerebral infarction observed on the days 90 after operation and discharge .
timeFrame: on the days 90 after operation and discharge
measure: The changes of he mean blood flow velocity (mBFV) after operation
timeFrame: on the days 3-5 after operation
measure: Total length of stay in the intensive care unit and hospital.
timeFrame: on the 90 days
measure: The modified Rankin scale at discharge, 30days, and 90 days
timeFrame: on the 30 and 90 days
measure: All-cause mortality rate up to 90 days.
timeFrame: on the 90 days
measure: Postoperative delirium incidence during hospitalization
timeFrame: on the days 1-3 after operation
measure: Postoperative cognitive dysfunction
timeFrame: At discharge，an average of 2 weeks
measure: The proportion of remedial treatment after CVS
timeFrame: At discharge，an average of 2 weeks
measure: Adverse events during hospitalization
timeFrame: At discharge，an average of 2 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital
state: Beijing
Study officials:
affiliation: Beijing Tiantan Hospital
name: Ruquan Han, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jing L, Wu Y, Liang F, Jian M, Bai Y, Wang Y, Liu H, Wang A, Chen X, Han R. Effect of early stellate ganglion block in cerebral vasospasm after aneurysmal subarachnoid hemorrhage (BLOCK-CVS): study protocol for a randomized controlled trial. Trials. 2022 Nov 4;23(1):922. doi: 10.1186/s13063-022-06867-9.