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

N

Nanjing Medical University

Status

Enrolling

Conditions

Transradial Access(TRA)
Intracranial Aneurysm

Treatments

Drug: Ropivacaine

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

176 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

176 participants in 2 patient groups

Brachial plexus block group(BPB)
Experimental group
Description:
All patients received receive Ultrasound-guided BPB with 0.15% ropivacaine 20ml 30min before surgery
Treatment:
Drug: Ropivacaine
Control group (Control)
No Intervention group
Description:
All patients received receive Ultrasound-guided BPB with normal saline 20ml 30min before surgery

Trial contacts and locations

1

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Central trial contact

Nan Li, M.D; Feng Feng, M.D

Data sourced from clinicaltrials.gov

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