Stellate Ganglion Block and Cerebral Vasospasm (BLOCK-CVS)

March 12, 2024 updated by: Ruquan Han, Beijing Tiantan Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

202

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100070
        • Recruiting
        • Beijing Tiantan Hospital
        • Contact:
        • Principal Investigator:
          • Ruquan Han, M.D., Ph.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
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.
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.
No Intervention: Blank control group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of symptomatic vasospasm during hospitalization
Time Frame: an average of 2 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total length of stay in the intensive care unit and hospital.
Time Frame: on the 90 days
Days
on the 90 days
The modified Rankin scale at discharge, 30days, and 90 days
Time Frame: on the 30 and 90 days
The modified Rankin scale ≤2 is defined as good prognosis
on the 30 and 90 days
All-cause mortality rate up to 90 days.
Time Frame: on the 90 days
The rate
on the 90 days
The incidence of CTA vasospasm on the days 3-5 after operation
Time Frame: 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
The incidence of hypoperfusion in CTP diagnosis on the days 3-5 after operation
Time Frame: on the days 3-5 after operation
The incidence of hypoperfusion in CTP diagnosis
on the days 3-5 after operation
The incidence of new cerebral infarction observed on the days 90 after operation and discharge .
Time Frame: 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
The incidence of TCD vasospasm during hospitalization
Time Frame: on the days 3-5 after operation
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
The changes of he mean blood flow velocity (mBFV) after operation
Time Frame: on the days 3-5 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
Postoperative delirium incidence during hospitalization
Time Frame: on the days 1-3 after operation
The rate
on the days 1-3 after operation
Postoperative cognitive dysfunction
Time Frame: At discharge，an average of 2 weeks
The rate
At discharge，an average of 2 weeks
The proportion of remedial treatment after CVS
Time Frame: At discharge，an average of 2 weeks
The rate
At discharge，an average of 2 weeks
Adverse events during hospitalization
Time Frame: At discharge，an average of 2 weeks
Myocardial infarction, cardiac arrest, pulmonary embolism, infection, SGB related complications, etc
At discharge，an average of 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Tiantan Hospital

Investigators

  • Principal Investigator: Ruquan Han, M.D., Ph.D, Beijing Tiantan Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2021

Primary Completion (Estimated)

December 30, 2024

Study Completion (Estimated)

December 30, 2024

Study Registration Dates

First Submitted

December 13, 2020

First Submitted That Met QC Criteria

December 29, 2020

First Posted (Actual)

December 31, 2020

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 12, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Z191100006619068

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Aneurysmal Subarachnoid Hemorrhage

Clinical Trials on Stellate ganglion block

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Türkiye

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe