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

Primary Purpose

Intracranial Aneurysm, Transradial Access(TRA)

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Ropivacaine
Sponsored by
The First Affiliated Hospital with Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Intracranial Aneurysm

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • The First Affiliated Hospital with Nanjing Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Brachial plexus block group(Group T)

Control group (Group C)

Arm Description

All patients received brachial plexus block 30min before surgery

All patients were not pretreated with brachial plexus block before operation

Outcomes

Primary Outcome Measures

Assess the degree of vasospasm in the upper extremity artery by angiography
The degree of vasospasm in the upper extremity artery was assessed by angiography during surgery.
Assessed thrombosis in the upper extremity artery by ultrasound
Upper extremity artery thrombosis was assessed by ultrasonography after surgery
Assessed stenosis in the upper extremity artery by ultrasound
Upper extremity artery stenosis was assessed by ultrasonography after surgery
Assessed occlusion in the upper extremity artery by ultrasound
Upper extremity artery occlusion was assessed by ultrasonography after surgery
Assess occlusion in the upper extremity artery by angiography or ultrasonography
Upper extremity artery occlusion was assessed by angiography or ultrasonography after surgery

Secondary Outcome Measures

Evaluate the hemodynamic changes of upper limb artery by ultrasound
The hemodynamic changes of upper limb artery were evaluated by ultrasound after BPB , such as the decrease of vessel cross-sectional area (area),Blood flow (Q), peak systolic velocity (PSV), end diastolic velocity (EDV), mean velocity (TAMAX ), pulsatility index (PI), resistance index (RI), etc. The change of these parameters will be combined to report in percent(%).
Evaluate the hemodynamic changes of upper limb vessels by ultrasound
The hemodynamic changes of upper limb vessels were evaluated by ultrasound after BPB. , such as the decrease of vessel cross-sectional area (area),Blood flow (Q), peak systolic velocity (PSV), end diastolic velocity (EDV), mean velocity (TAMAX ), pulsatility index (PI), resistance index (RI), etc. The change of these parameters will be combined to report in percent (%).
Recorded the changes of inflammatory cytokine IL-6 in plasma before and after operation.
The changes of inflammatory cytokine IL-6 in plasma were recorded beforeand after operation by Flow immunofluorescence assay.
Recorded the changes of inflammatory cytokine IL-10 in plasma before and after operation.
The changes of inflammatory cytokine IL-10 in plasma were recorded beforeand after operation by Flow immunofluorescence assay.
Evaluated the incidence of postoperative cerebral infarction by magnetic resonance imagingoperation(MRI)
The incidence of postoperative cerebral infarction was evaluated by MRI,Including lacunar cerebral infarction.
Evaluate the hemodynamic changes of upper limb vessels by ultrasound
The hemodynamic changes of upper limb vessels were evaluated by ultrasound after BPB. , such as the decrease of vessel cross-sectional area (area),Blood flow (Q), peak systolic velocity (PSV), end diastolic velocity (EDV), mean velocity (TAMAX ), pulsatility index (PI), resistance index (RI), etc. The change of these parameters will be combined to report in percent (%).

Full Information

First Posted
June 27, 2023
Last Updated
September 11, 2023
Sponsor
The First Affiliated Hospital with Nanjing Medical University
Collaborators
Xuzhou Central Hospital, Huizhou Municipal Central Hospital, The First People's Hospital of Changzhou, Nanjing Jiangbei Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06035692
Brief Title
Application of Brachial Plexus Block in Patients Undergoing Cerebral Aneurysm Embolization Via Transradial Approach
Acronym
ABPBCAETRA
Official Title
The Protective Effect of Brachial Plexus Block on Upper Limb Vascular Injury in Patients Undergoing Cerebral Aneurysm Embolization Via Transradial Approach
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Affiliated Hospital with Nanjing Medical University
Collaborators
Xuzhou Central Hospital, Huizhou Municipal Central Hospital, The First People's Hospital of Changzhou, Nanjing Jiangbei Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of this study was to investigate the feasibility and mechanism of brachial plexus block(BPB) preconditioning in preventing upper limb vascular injury in patients undergoing interventional surgery for intracranial aneurysms via transradial access(TRA). A multicenter prospective clinical trial was designed. The study subjects were patients undergoing cerebral aneurysm embolization with TRA. BPB was given in the experimental group patients and no BPB in the control group. To evaluate the short and long-term protective effects of brachial plexus block on the upper limb blood vessels injury after operation, the upper limb vasospasm and hemodynamic changes during operation, upper limb vascular thrombosis and radial artery occlusion after operation were observed in the two groups.
Detailed Description
The aim of this study was to investigate the feasibility and mechanism of BPB preconditioning in preventing upper limb vascular injury in patients undergoing interventional surgery for intracranial aneurysms viaTRA. A multicenter prospective clinical trial was designed, and the study subjects were patients undergoing cerebral aneurysm embolization with TRA. The experimental group was givenBPB, and the control group was not given BPB.Firstly, the minimum effective concentration (MEC50 and MEC95) of BPB for preventing radial artery spasm was determined by sequential method. Then the experimental group patients was treated with MEC95.The hemodynamic changes and spasm of the upper limb vessels during the operation, and the complications such as thrombosis of the upper limb vessels and radial artery occlusion after the operation were compared between the two groups, to evaluate the short-term and long-term protective effects of BPB on upper limb vascular injury in those patients.The content of IL-2,IL-4,IL-6,IL-10,IL-17,IL-12p70,IFN-γ,TNF-α in plasma was determined by flow immunofluorescence before and after operation, to compare the changes of inflammatory cytokines between the two groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Aneurysm, Transradial Access(TRA)

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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. The experimental group was given brachial plexus block 30 minutes before surgery, and the control group was given routine treatment.
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
In this study, participants, data recorders(investigators), and outcome assessor were unaware of group assignments
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Brachial plexus block group(Group T)
Arm Type
Experimental
Arm Description
All patients received brachial plexus block 30min before surgery
Arm Title
Control group (Group C)
Arm Type
No Intervention
Arm Description
All patients were not pretreated with brachial plexus block before operation
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Other Intervention Name(s)
brachial plexus block
Intervention Description
The MEC50 and MEC95 of ropivacaine for brachial plexus block was measured by sequential method, and then the patients in the experimental group were treated with MEC95.
Primary Outcome Measure Information:
Title
Assess the degree of vasospasm in the upper extremity artery by angiography
Description
The degree of vasospasm in the upper extremity artery was assessed by angiography during surgery.
Time Frame
During the operation
Title
Assessed thrombosis in the upper extremity artery by ultrasound
Description
Upper extremity artery thrombosis was assessed by ultrasonography after surgery
Time Frame
Day 1 after surgery
Title
Assessed stenosis in the upper extremity artery by ultrasound
Description
Upper extremity artery stenosis was assessed by ultrasonography after surgery
Time Frame
Day 1 after surgery
Title
Assessed occlusion in the upper extremity artery by ultrasound
Description
Upper extremity artery occlusion was assessed by ultrasonography after surgery
Time Frame
Day 1 after surgery
Title
Assess occlusion in the upper extremity artery by angiography or ultrasonography
Description
Upper extremity artery occlusion was assessed by angiography or ultrasonography after surgery
Time Frame
Month 1 after surgery
Secondary Outcome Measure Information:
Title
Evaluate the hemodynamic changes of upper limb artery by ultrasound
Description
The hemodynamic changes of upper limb artery were evaluated by ultrasound after BPB , such as the decrease of vessel cross-sectional area (area),Blood flow (Q), peak systolic velocity (PSV), end diastolic velocity (EDV), mean velocity (TAMAX ), pulsatility index (PI), resistance index (RI), etc. The change of these parameters will be combined to report in percent(%).
Time Frame
Before the operation
Title
Evaluate the hemodynamic changes of upper limb vessels by ultrasound
Description
The hemodynamic changes of upper limb vessels were evaluated by ultrasound after BPB. , such as the decrease of vessel cross-sectional area (area),Blood flow (Q), peak systolic velocity (PSV), end diastolic velocity (EDV), mean velocity (TAMAX ), pulsatility index (PI), resistance index (RI), etc. The change of these parameters will be combined to report in percent (%).
Time Frame
Day 1 after surgery
Title
Recorded the changes of inflammatory cytokine IL-6 in plasma before and after operation.
Description
The changes of inflammatory cytokine IL-6 in plasma were recorded beforeand after operation by Flow immunofluorescence assay.
Time Frame
Day 1 after surgery
Title
Recorded the changes of inflammatory cytokine IL-10 in plasma before and after operation.
Description
The changes of inflammatory cytokine IL-10 in plasma were recorded beforeand after operation by Flow immunofluorescence assay.
Time Frame
Day 1 after surgery
Title
Evaluated the incidence of postoperative cerebral infarction by magnetic resonance imagingoperation(MRI)
Description
The incidence of postoperative cerebral infarction was evaluated by MRI,Including lacunar cerebral infarction.
Time Frame
Day 1 after surgery
Title
Evaluate the hemodynamic changes of upper limb vessels by ultrasound
Description
The hemodynamic changes of upper limb vessels were evaluated by ultrasound after BPB. , such as the decrease of vessel cross-sectional area (area),Blood flow (Q), peak systolic velocity (PSV), end diastolic velocity (EDV), mean velocity (TAMAX ), pulsatility index (PI), resistance index (RI), etc. The change of these parameters will be combined to report in percent (%).
Time Frame
Month 1 after the surgery
Other Pre-specified Outcome Measures:
Title
Calculate MEC50 and MEC95 of ropivacaine in brachial plexus block by sequential method
Description
The minimum effective concentration(MEC50 and MEC95) of ropivacaine for brachial plexus block to prevent radial artery spasm during operation was determined by sequential method.
Time Frame
During the operation
Title
Record VAS score by questionnaire after the surgery
Description
VAS score was record by questionnaire.The VAS was scored from 0 to 10, with 0 indicating no pain and 10 indicating severe and unbearable pain. The pain scores of patients were recorded after awakening.
Time Frame
Day 0 after the surgery
Title
Record VAS score by questionnaire 24h after the surgery
Description
VAS score was record by questionnaire.The VAS was scored from 0 to 10, with 0 indicating no pain and 10 indicating severe and unbearable pain. The pain scores of patients were recorded 1 day after operation
Time Frame
Day 1 after the surgery
Title
Record physician satisfaction by questionnaire
Description
Physician satisfaction was scored on a scale of 1-5, with a score of 1 indicating very poor and dissatisfied experience and a score of 5 indicating very satisfied. The surgeons were asked to fill in the satisfaction questionnaire according to the operation situation after operation and recorded.
Time Frame
Day 0 after the surgery
Title
Record complications of brachial plexus block
Description
The complications of brachial plexus block such as hematoma, infection, nerve injury were recorded after the surgery.
Time Frame
Day 1 after the surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Feng Feng, Master
Phone
13814073686
Email
316637881@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
Nan Li, Master
Phone
15850647102
Email
mzlinan2010@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jingjin Li, MD
Organizational Affiliation
The First Affiliated Hospital with Nanjing Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital with Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Feng Feng, Master
Phone
13814073686
Email
316637881@qq.com
First Name & Middle Initial & Last Name & Degree
Nan Li, Master
Phone
15850647102
Email
mzlinan2010@163.com
First Name & Middle Initial & Last Name & Degree
Jingjin Li, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

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

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