Clinical trial NCT06035692: Application of Brachial Plexus Block in Patients Undergoing Cerebral Aneurysm Embolization Via Transradial Approach
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intracranial Aneurysm
Transradial Access(TRA)
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
Collaborators: name: Xuzhou Central Hospital
name: Huizhou Municipal Central Hospital
name: Nanjing Jiangbei Hospital
First posted: 2023-09-13
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Assess the RAS by angiography at the begining of the operation
timeFrame: During the operation
measure: Evaluate the degree of RAS by angiography at the end of the operation
timeFrame: During the operation
Secondary outcomes:
measure: Assess unfavorable RA for repeated trans-radial interventions (TRI) at 1 month after surgery by ultrasonography.
timeFrame: Month 1 after surgery
measure: Record the incidence of intima-media thickness (IMT) ≥0.5 mm and diameter <1.5mm at 1 month after surgery by ultrasonography.
timeFrame: Month 1 after surgery
measure: Record the incidence of radial artery occlusion at 1 month after surgery by ultrasonography.
timeFrame: Month 1 after surgery
measure: Record the incidence of moderate and diffuse stenosis (> 10 mm in length) at 1 month after surgery by ultrasonography.
timeFrame: Month 1 after surgery
measure: Record the incidence of severe focal or diffuse stenosis (regardless of length) at 1 month after surgery by ultrasonography.
timeFrame: Month 1 after surgery
measure: Record the use of nitroglycerin during the operation
timeFrame: During the operation
measure: Record the incidence of intraoperative hypotension
timeFrame: During the operation
measure: Record physician satisfaction by questionnaire
timeFrame: Day 0 after the surgery
measure: Record the duration of radial artery puncture
timeFrame: At the begining of the operation
measure: Measured diameter and the hemodynamic parameters of radial artery by ultrasound 30min after BPB or control interventions
timeFrame: 30min after BPB or control interventions
measure: Measured diameter and the hemodynamic parameters of radial artery by ultrasound 24h after surgery
timeFrame: 24h after surgery
measure: Measured diameter and the hemodynamic parameters of radial artery by ultrasound 1 month after surgery
timeFrame: Month 1 after surgery
measure: Measured diameter and the hemodynamic parameters of ulnar artery by ultrasound 30min after BPB or control interventions
timeFrame: 30min after BPB or control interventions
measure: Measured diameter and the hemodynamic parameters of ulnar artery by ultrasound 24h after surgery
timeFrame: 24h after surgery
measure: Measured diameter and the hemodynamic parameters of ulnar artery by ultrasound 1 month after surgery
timeFrame: Month 1 after surgery
measure: Measured diameter and the hemodynamic parameters of brachial artery by ultrasound 30min after BPB or control interventions
timeFrame: 30min after BPB or control interventions
measure: Measured diameter and the hemodynamic parameters of brachial artery by ultrasound 24h after surgery
timeFrame: 24h after surgery
measure: Measured diameter and the hemodynamic parameters of brachial artery by ultrasound 1 month after surgery
timeFrame: Month 1 after surgery
measure: Record mean arterial pressure at different time points
timeFrame: During the operation
measure: Record perioperative complications
timeFrame: Day 1 after the surgery
measure: Recorded the levels of eight inflammatory factors
timeFrame: Day 1 after the surgery
measure: Recorded the incidence of postoperative acute embolism events
timeFrame: Day 1 after the surgery
Other outcomes:
measure: Calculate MEC50 and MEC95 of ropivacaine in brachial plexus block by sequential method
timeFrame: During the operation
measure: Record diameter and the hemodynamic parameters of radial artery by ultrasound
timeFrame: Day 1 before surgery
measure: Record diameter and the hemodynamic parameters of brachial artery by ultrasound
timeFrame: Day 1 before surgery
measure: Record diameter and the hemodynamic parameters of ulnar artery by ultrasound
timeFrame: Day 1 before surgery
Locations:
city: Nanjing
country: China
facility: The First Affiliated Hospital with Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Jingjin Li, M.D
role: PRINCIPAL_INVESTIGATOR
References: