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

Effect of Brachial Plexus Block on Outcomes of Upper Extremity Arteries After Intracranial Aneurysm Interventional Surgery Via Transradial Access: A Randomized Clinical Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Intracranial Aneurysm; Transradial Access(TRA)
• Intervention / Treatment: Drug: Ropivacaine

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 176
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Feng Feng, M.D; Phone Number: 13814073686; Email: 316637881@qq.com
• Study Contact Backup: Name: Nan Li, M.D; Phone Number: 15850647102; Email: mzlinan2010@163.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • Recruiting
      • The First Affiliated Hospital with Nanjing Medical University
      • Principal Investigator: Jingjin Li, M.D
      • Contact: Feng Feng, M.D; Phone Number: 13814073686; Email: 316637881@qq.com
      • Contact: Nan Li, M.D; Phone Number: 15850647102; Email: mzlinan2010@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Brachial plexus block group（BPB）; All patients received receive Ultrasound-guided BPB with 0.15% ropivacaine 20ml 30min before surgery	Drug: 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.; Other Names: brachial plexus block
No Intervention: Control group （Control）; All patients received receive Ultrasound-guided BPB with normal saline 20ml 30min before surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess unfavorable RA for repeated trans-radial interventions (TRI) at 1 month after surgery by ultrasonography.	The the radial artery was evaluated at 1 month after surgery using ultrasonography by an anesthesiologist who was blinded to the group assignments.The radial artery was considered unfavorable for repeated-TRI if it exhibited any of the following criteria: total occlusion, intima-media thickness (IMT) ≥0.5 mm and diameter <1.5mm, moderate and diffuse stenosis (> 10 mm in length), or severe focal or diffuse stenosis (regardless of length).	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.	The incidence of intima-media thickness (IMT) ≥0.5 mm and diameter <1.5mm as a component of unfavorable RA for repeated TRI was recorded at one month follow-up.	Month 1 after surgery
Record the incidence of radial artery occlusion at 1 month after surgery by ultrasonography.	The incidence of radial artery occlusion as a component of unfavorable RA for repeated TRI was recorded at one month follow-up.	Month 1 after surgery
Record the incidence of moderate and diffuse stenosis (> 10 mm in length) at 1 month after surgery by ultrasonography.	The incidence of moderate and diffuse stenosis (> 10 mm in length) as a component of unfavorable RA for repeated TRI was recorded at one month follow-up.	Month 1 after surgery
Record the incidence of severe focal or diffuse stenosis (regardless of length) at 1 month after surgery by ultrasonography.	The incidence of severe focal or diffuse stenosis (regardless of length) as a component of unfavorable RA for repeated TRI was recorded at one month follow-up.	Month 1 after surgery
Record the use of nitroglycerin during the operation	When the radial sheath was inserted, upper limb angiography was performed, and nitroglycerin 200ug was administered if any degree of vasospasm in the upper limb was observed on the angiography. The administration of nitroglycerin in each group was recorded.	During the operation
Record the incidence of intraoperative hypotension	The definition of intraoperative hypotension was a mean arterial blood pressure below 60mmHg.	During the operation
Record physician satisfaction by questionnaire	Physician satisfaction was scored on a scale of 1-10, with a score of 1 indicating very poor and dissatisfied experience and a score of 10 indicating very satisfied. The surgeons were asked to fill in the satisfaction questionnaire according to the operation situation after operation and recorded.	Day 0 after the surgery
Record the duration of radial artery puncture	The time from the beginning of the radial artery puncture to the placement of the radial sheath was recorded.	At the begining of the operation
Measured diameter and the hemodynamic parameters of radial artery by ultrasound 30min after BPB or control interventions	The radial artery was evaluated(include diameter, PSV,EDV,TAMAX,PI,RI) before the surgery using ultrasonography by an anesthesiologist who was blinded to the group assignments.	30min after BPB or control interventions
Measured diameter and the hemodynamic parameters of radial artery by ultrasound 24h after surgery	The radial artery was evaluated(include diameter, PSV,EDV,TAMAX,PI,RI) before the surgery using ultrasonography by an anesthesiologist who was blinded to the group assignments.	24h after surgery
Measured diameter and the hemodynamic parameters of radial artery by ultrasound 1 month after surgery	The radial artery was evaluated(include diameter, PSV,EDV,TAMAX,PI,RI) before the surgery using ultrasonography by an anesthesiologist who was blinded to the group assignments.	Month 1 after surgery
Measured diameter and the hemodynamic parameters of ulnar artery by ultrasound 30min after BPB or control interventions	The ulnar artery was evaluated(include diameter, PSV,EDV,TAMAX,PI,RI) before the surgery using ultrasonography by an anesthesiologist who was blinded to the group assignments.	30min after BPB or control interventions
Measured diameter and the hemodynamic parameters of ulnar artery by ultrasound 24h after surgery	The ulnar artery was evaluated(include diameter, PSV,EDV,TAMAX,PI,RI) before the surgery using ultrasonography by an anesthesiologist who was blinded to the group assignments.	24h after surgery
Measured diameter and the hemodynamic parameters of ulnar artery by ultrasound 1 month after surgery	The ulnar artery was evaluated(include diameter, PSV,EDV,TAMAX,PI,RI) before the surgery using ultrasonography by an anesthesiologist who was blinded to the group assignments.	Month 1 after surgery
Measured diameter and the hemodynamic parameters of brachial artery by ultrasound 30min after BPB or control interventions	The brachial artery was evaluated(include diameter, PSV,EDV,TAMAX,PI,RI) before the surgery using ultrasonography by an anesthesiologist who was blinded to the group assignments.	30min after BPB or control interventions
Measured diameter and the hemodynamic parameters of brachial artery by ultrasound 24h after surgery	The brachial artery was evaluated(include diameter, PSV,EDV,TAMAX,PI,RI) before the surgery using ultrasonography by an anesthesiologist who was blinded to the group assignments.	24h after surgery
Measured diameter and the hemodynamic parameters of brachial artery by ultrasound 1 month after surgery	The brachial artery was evaluated(include diameter, PSV,EDV,TAMAX,PI,RI) before the surgery using ultrasonography by an anesthesiologist who was blinded to the group assignments.	Month 1 after surgery
Record mean arterial pressure at different time points	The mean intraoperative arterial pressure from T0 to T8 was recorded. T0 indicates time after entering the operating room; T1,30 minutes after BPB or control procedure; T2, 5 minutes after induction of general anesthesia; T3, angiography after the radial sheath enters the radial artery; T4,1minutes after angiography; T5, 3minutes after angiography; T6, 5minutes after angiography; T7, 10 minutes after angiography; T8, completion of the operation.	During the operation
Record perioperative complications	Perioperative complications include puncture site complications, brachial plexus complications, and other cardiovascular and cerebrovascular complications	Day 1 after the surgery
Recorded the levels of eight inflammatory factors	The hospital laboratory conducted an examination on 8 inflammatory factors (include IL-2,IL-4,IL-6,IL-10,IL-17,IL-12P70,IFN-r,TNF-a) to assess postoperative infection, and subsequently provided the results.	Day 1 after the surgery
Recorded the incidence of postoperative acute embolism events	A head magnetic resonance imaging(MRI) was conducted to document the occurrence of postoperative embolic events, such as acute cerebral infarction.	Day 1 after the surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Record diameter and the hemodynamic parameters of radial artery by ultrasound	The radial artery was evaluated(include diameter, PSV,EDV,TAMAX,PI,RI) before the surgery using ultrasonography by an anesthesiologist who was blinded to the group assignments.	Day 1 before surgery
Record diameter and the hemodynamic parameters of brachial artery by ultrasound	The brachial artery was evaluated(include diameter, PSV,EDV,TAMAX,PI,RI) before the surgery using ultrasonography by an anesthesiologist who was blinded to the group assignments.	Day 1 before surgery
Record diameter and the hemodynamic parameters of ulnar artery by ultrasound	The ulnar artery was evaluated(include diameter, PSV,EDV,TAMAX,PI,RI) before the surgery using ultrasonography by an anesthesiologist who was blinded to the group assignments.	Day 1 before surgery
Calculate MEC50 and MEC95 of ropivacaine in brachial plexus block by sequential method	The minimum effective concentration（MEC50 and MEC90） of ropivacaine for brachial plexus block to prevent radial artery spasm during operation was determined by sequential method.	During the operation

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital with Nanjing Medical University
• Collaborators: Xuzhou Central Hospital; Huizhou Municipal Central Hospital; Nanjing Jiangbei Hospital
• Investigators: Principal Investigator: Jingjin Li, M.D, The First Affiliated Hospital with Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): February 29, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: June 27, 2023
• First Submitted That Met QC Criteria: September 11, 2023
• First Posted (Actual): September 13, 2023

Study Record Updates

• Last Update Posted (Estimated): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 25, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: BPB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: If anyone is interested in this study, please contact us, and I think we would like to share IPD with him
• IPD Sharing Time Frame: Month 1
• IPD Sharing Access Criteria: If anyone is interested in this study, please contact us, and I think we would like to share IPD with him
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No