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

Intracranial Aneurysm Clinical Trial

— ABPBCAETRA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06035692
• Other study ID #: BPB
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: February 2024
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: Feng Feng, M.D
• Phone: 13814073686
• Email: 316637881[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 176
• Est. completion date: June 30, 2024
• Est. primary completion date: February 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 18-75 years old, BMI<28kg/m2

• ASA physical status ?-?

• 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

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm

Intervention

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.

Locations

Country	Name	City	State
China	The First Affiliated Hospital with Nanjing Medical University	Nanjing	Jiangsu

Sponsors (4)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University	Huizhou Municipal Central Hospital, Nanjing Jiangbei Hospital, Xuzhou Central Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Record the incidence of intraoperative hypotension	The definition of intraoperative hypotension was a mean arterial blood pressure below 60mmHg.	During the operation
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Record perioperative complications	Perioperative complications include puncture site complications, brachial plexus complications, and other cardiovascular and cerebrovascular complications	Day 1 after the surgery
Secondary	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
Secondary	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