Stellate Ganglion Block and Cerebral Vasospasm

NCT ID: NCT04691271

Last Updated: 2024-03-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 202 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-01
• Study Completion Date: 2024-12-30

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.

Conditions

Aneurysmal Subarachnoid Hemorrhage; Stellate Ganglion Block; Cerebral Vasospasm

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Stellate ganglion block

Intervention Type: PROCEDURE

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Tiantan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ruquan Han

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ruquan Han, M.D., Ph.D

Role: PRINCIPAL_INVESTIGATOR

Beijing Tiantan Hospital

Locations

Beijing Tiantan Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ruquan Han, M.D., Ph.D

Role: CONTACT

ruquan.han@gmail.com

8610-59976660

Facility Contacts

Ruquan Han, M.D., Ph.D

Role: primary

ruquan.han@gmail.com

8610-59976660

References

Wu Y, Lin F, Bai Y, Liang F, Wang X, Wang B, Jian M, Wang Y, Liu H, Wang A, Chen X, Han R. Early stellate ganglion block for improvement of postoperative cerebral blood flow velocity after aneurysmal subarachnoid hemorrhage: results of a pilot randomized controlled trial. J Neurosurg. 2023 Apr 28;139(5):1339-1347. doi: 10.3171/2023.3.JNS222567. Print 2023 Nov 1.

Reference Type: DERIVED

PMID: 37119094 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36333751 (View on PubMed)

Other Identifiers

Z191100006619068

Identifier Type: -

Identifier Source: org_study_id