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Stellate Ganglion Block and Cerebral Vasospasm (BLOCK-CVS)

Primary Purpose

Aneurysmal Subarachnoid Hemorrhage, Stellate Ganglion Block, Cerebral Vasospasm

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Stellate ganglion block
Sponsored by
Beijing Tiantan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Aneurysmal Subarachnoid Hemorrhage focused on measuring Cerebral vasospasm, Stellate ganglion block

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Beijing Tiantan HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Blank control group

Arm 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.

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.

Outcomes

Primary Outcome Measures

The incidence of symptomatic vasospasm within 14 days after aSAH
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.

Secondary Outcome Measures

The incidence of TCD vasospasm withing 14 days after aSAH.
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.
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.
The incidence of hypoperfusion in CTP diagnosis on the days 3-5 after operation
The incidence of hypoperfusion in CTP diagnosis
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.
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
Total length of stay in the intensive care unit and hospital.
Days
The modified Rankin scale at discharge, 30days, and 90 days
The modified Rankin scale ≤2 is defined as good prognosis
All-cause mortality rate up to 90 days.
The rate

Full Information

First Posted
December 13, 2020
Last Updated
February 17, 2023
Sponsor
Beijing Tiantan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04691271
Brief Title
Stellate Ganglion Block and Cerebral Vasospasm
Acronym
BLOCK-CVS
Official Title
Effect of Early Stellate Ganglion Block for Cerebral Vasospasm After Aneurysmal Subarachnoid Hemorrhage: a Randomized Controlled Trial (BLOCK-CVS)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Tiantan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aneurysmal Subarachnoid Hemorrhage, Stellate Ganglion Block, Cerebral Vasospasm
Keywords
Cerebral vasospasm, Stellate ganglion block

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
228 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm 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.
Arm Title
Blank control group
Arm Type
No Intervention
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Stellate ganglion block
Intervention Description
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.
Primary Outcome Measure Information:
Title
The incidence of symptomatic vasospasm within 14 days after aSAH
Description
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.
Time Frame
within 14 days after aSAH
Secondary Outcome Measure Information:
Title
The incidence of TCD vasospasm withing 14 days after aSAH.
Description
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.
Time Frame
within 14 days after aSAH
Title
The incidence of CTA vasospasm on the days 3-5 after operation
Description
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.
Time Frame
on the days 3-5 after operation
Title
The incidence of hypoperfusion in CTP diagnosis on the days 3-5 after operation
Description
The incidence of hypoperfusion in CTP diagnosis
Time Frame
on the days 3-5 after operation
Title
The incidence of new cerebral infarction observed on the days 90 after operation and discharge .
Description
New cerebral infarction is defined only as the appearance of new low-density infarct shadow on CT image compared with preoperation.
Time Frame
on the days 90 after operation and discharge
Title
The changes of he mean blood flow velocity (mBFV) after operation
Description
the changes in the mean blood flow velocity (mBFV) of all large intracranial anterior circulation vessels
Time Frame
on the day before surgery (T0) and on the immediate (T1),1st (T2), 2nd (T3), 3rd (T4), 5th (T5) ,7th(T6) days after operation.
Title
Total length of stay in the intensive care unit and hospital.
Description
Days
Time Frame
on the 90 days
Title
The modified Rankin scale at discharge, 30days, and 90 days
Description
The modified Rankin scale ≤2 is defined as good prognosis
Time Frame
on the 30 and 90 days
Title
All-cause mortality rate up to 90 days.
Description
The rate
Time Frame
on the 90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ruquan Han, M.D., Ph.D
Phone
8610-59976660
Email
ruquan.han@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruquan Han, M.D., Ph.D
Organizational Affiliation
Beijing Tiantan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Tiantan Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100070
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ruquan Han, M.D., Ph.D
Phone
8610-59976660
Email
ruquan.han@gmail.com
First Name & Middle Initial & Last Name & Degree
Ruquan Han, M.D., Ph.D

12. IPD Sharing Statement

Citations:
PubMed Identifier
36333751
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.
Results Reference
derived

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Stellate Ganglion Block and Cerebral Vasospasm

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