Application of Brachial Plexus Block in Patients Undergoing Cerebral Aneurysm Embolization Via Transradial Approach

NCT06035692 | Recruiting DMC

• 1 other identifier: BPB
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was toinvestigate the effect of BPB on outcome of upper extremity arteries in patients undergoing interventional embolization of intracranial aneurysms via TRA. A multicenter prospective clinical trial was designed. The study subjects were patients undergoing cerebral aneurysm embolization with TRA. BPB was given in the BPB group patients and no BPB in the control group.The incidence of radial artery spasm (RAS) diagnosed by intraoperative angiography and the occurrence of the unfavorable RA for repeated trans-radial interventions (TRI) diagnosed by vascular ultrasound 1 month after surgery， perioperative changes of blood flow parameters in upper limb vessels,postoperative inflammatory factors and complications were observed in the two groups.

Conditions

Intracranial Aneurysm; Transradial Access(TRA)

Outcome Measures

Primary Outcomes (2)

• Assess the RAS by angiography at the begining of the operation

  The RAS was assessed through radial artery angiography following the insertion of the arterial catheter.

  During the operation

• Evaluate the degree of RAS by angiography at the end of the operation

  The severity of RAS was classified as severe, moderate, or mild based on the degree of stenosis observed on radial arteriography: greater than 75%, 25-75%, and less than 25% of the vessel diameter, respectively. In addition, if the combined spasm length exceeded 2cm, the severity increased by 1 grade.

  During the operation

Secondary Outcomes (22)

• Assess unfavorable RA for repeated trans-radial interventions (TRI) at 1 month after surgery by ultrasonography.

  Month 1 after surgery

• Record the incidence of intima-media thickness (IMT) ≥0.5 mm and diameter <1.5mm at 1 month after surgery by ultrasonography.

  Month 1 after surgery

• Record the incidence of radial artery occlusion at 1 month after surgery by ultrasonography.

  Month 1 after surgery

• Record the incidence of moderate and diffuse stenosis (> 10 mm in length) at 1 month after surgery by ultrasonography.

  Month 1 after surgery

• Record the incidence of severe focal or diffuse stenosis (regardless of length) at 1 month after surgery by ultrasonography.

  Month 1 after surgery

Other Outcomes (4)

• Calculate MEC50 and MEC95 of ropivacaine in brachial plexus block by sequential method

  During the operation

• Record diameter and the hemodynamic parameters of radial artery by ultrasound

  Day 1 before surgery

• Record diameter and the hemodynamic parameters of brachial artery by ultrasound

  Day 1 before surgery

Study Arms (2)

Brachial plexus block group（BPB）

EXPERIMENTAL

All patients received receive Ultrasound-guided BPB with 0.15% ropivacaine 20ml 30min before surgery

Drug: Ropivacaine

Control group （Control）

NO INTERVENTION

All patients received receive Ultrasound-guided BPB with normal saline 20ml 30min before surgery

Interventions

Ropivacaine DRUG

According to the results of the preliminary experiment, the BPB group was given ultrasound-guided BPB with 0.15% ropivacaine 20ml.The ropivacaine concentration was the 90% minimum effective concentration(MEC90) for preventing vasospasm during operation.

Also known as: brachial plexus block

Brachial plexus block group（BPB）

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old, BMI\<28kg/m2
• ASA physical status Ⅰ-Ⅲ
• Elective interventional surgery for intracranial aneurysms via TRA
• willing to sign informed consent

You may not qualify if:

• patients allergic to local anesthetics
• neck infection on the surgical side
• Preoperative upper extremity ultrasound or DSA showed radial artery occlusion and arteriovenous fistula
• The diameter of radial artery was still less than 2mm after brachial plexus block
• Axillary artery occlusion and other vascular anatomical abnormalities may affect the operation
• Radial artery patency: Barbeau type D
• The history of hand trauma may affect the establishment of radial artery; access, or the use of radial artery as a bypass or dialysis vessel
• patients with incomplete block effect after nerve block were detected;
• The patient refused to participate in the study or cooperate with the follow-up

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead
• Xuzhou Central Hospital: collaborator
• Huizhou Municipal Central Hospital: collaborator
• Nanjing Jiangbei Hospital: collaborator

Study Sites (1)

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, 210029, China

RECRUITING

MeSH Terms

Conditions

Intracranial Aneurysm

Interventions

Ropivacaine; Brachial Plexus Block

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Nerve Block; Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• Jingjin Li, M.D

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Feng Feng, M.D

CONTACT

13814073686; 316637881@qq.com

Nan Li, M.D

CONTACT

15850647102; mzlinan2010@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: In this study, participants, data recorders(investigators), and outcome assessor were unaware of group assignments.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a multicenter prospective randomized controlled study.Patients were assigned to the two groups with the use of central randomization and competitive enrollment.

Study Record Dates

• First Submitted: June 27, 2023
• First Posted: September 13, 2023
• Study Start: June 1, 2023
• Primary Completion: February 29, 2024
• Study Completion: June 30, 2024
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Month 1
• Access Criteria: If anyone is interested in this study, please contact us, and I think we would like to share IPD with him

Locations

CN (1)