Effect of Brachial Plexus Block on Outcomes of Upper Extremity Arteries After Intracranial Aneurysm Interventional Surgery Via Transradial Access: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 176
- 试验地点
- 1
- 主要终点
- Assess the RAS by angiography at the begining of the operation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
In this study, participants, data recorders(investigators), and outcome assessor were unaware of group assignments.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Brachial plexus block group（BPB）
All patients received receive Ultrasound-guided BPB with 0.15% ropivacaine 20ml 30min before surgery
干预措施: Ropivacaine (Drug)
结局指标
主要结局
Assess the RAS by angiography at the begining of the operation
时间窗: During the operation
The RAS was assessed through radial artery angiography following the insertion of the arterial catheter.
Evaluate the degree of RAS by angiography at the end of the operation
时间窗: During 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.
次要结局
- Assess unfavorable RA for repeated trans-radial interventions (TRI) 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)
- Recorded the incidence of postoperative acute embolism events(Day 1 after the 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 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)
- Measured diameter and the hemodynamic parameters of radial artery by ultrasound 24h after surgery(24h after surgery)
- Measured diameter and the hemodynamic parameters of radial artery by ultrasound 1 month after surgery(Month 1 after surgery)
- Measured diameter and the hemodynamic parameters of ulnar artery by ultrasound 24h after surgery(24h after surgery)
- Record the use of nitroglycerin during the operation(During the operation)
- Record the incidence of intraoperative hypotension(During the operation)
- Record the duration of radial artery puncture(At the begining of the operation)
- Measured diameter and the hemodynamic parameters of ulnar artery by ultrasound 30min after BPB or control interventions(30min after BPB or control interventions)
- Measured diameter and the hemodynamic parameters of ulnar artery by ultrasound 1 month after surgery(Month 1 after surgery)
- Measured diameter and the hemodynamic parameters of brachial artery by ultrasound 30min after BPB or control interventions(30min after BPB or control interventions)
- Measured diameter and the hemodynamic parameters of brachial artery by ultrasound 1 month after surgery(Month 1 after surgery)
- Record physician satisfaction by questionnaire(Day 0 after the surgery)
- Measured diameter and the hemodynamic parameters of radial artery by ultrasound 30min after BPB or control interventions(30min after BPB or control interventions)
- Measured diameter and the hemodynamic parameters of brachial artery by ultrasound 24h after surgery(24h after surgery)
- Record mean arterial pressure at different time points(During the operation)
- Record perioperative complications(Day 1 after the surgery)
- Recorded the levels of eight inflammatory factors(Day 1 after the surgery)