NCT06035692

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 176 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Intracranial Aneurysm
• Transradial Access(TRA)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-06-01
• Primary completion: 2024-02-29
• Completion: 2024-06-30
• First posted: 2023-09-13
• Last updated: 2024-02-28

Locations

1 site across 1 country: China