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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

176 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-01

Study Completion Date

2024-06-30

Brief Summary

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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.

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Detailed Description

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The aim of this study was to investigate 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, and the study subjects were patients undergoing cerebral aneurysm embolization with TRA. Participants were randomly assigned to receive Ultrasound-guided BPB with 0.15% ropivacaine 20ml (BPB group) or normal saline 20ml (Control group) in 1:1ratio.The primary outcomes measured were the incidence of 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.Secondary outcomes included the severity of RAS, Components of unfavorable RA for repeated TRI, intraoperative nitroglycerin use, Intraoperative hypotension, surgeon satisfaction scores.

Conditions

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Intracranial Aneurysm Transradial Access(TRA)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

In this study, participants, data recorders(investigators), and outcome assessor were unaware of group assignments.

Study Groups

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Brachial plexus block group（BPB）

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

Group Type EXPERIMENTAL

Ropivacaine

Intervention Type 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.

Control group （Control）

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Ropivacaine

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.

Intervention Type DRUG

Other Intervention Names

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brachial plexus block

Eligibility Criteria

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Inclusion Criteria

* 18-75 years old, BMI\<28kg/m2
* ASA physical status Ⅰ-Ⅲ
* Elective interventional surgery for intracranial aneurysms via TRA
* willing to sign informed consent

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No