ABPBCAETRA: Application of Brachial Plexus Block in Patients Undergoing Cerebral Aneurysm Embolization Via Transradial Approach
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Brachial plexus block group（Group T） All patients received brachial plexus block 30min before surgery |
Drug: Ropivacaine
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.
Other Names:
|
| No Intervention: Control group （Group C） All patients were not pretreated with brachial plexus block before operation |
Outcome Measures
Primary Outcome Measures
- Assess the degree of vasospasm in the upper extremity artery by angiography [During the operation]
The degree of vasospasm in the upper extremity artery was assessed by angiography during surgery.
- Assessed thrombosis in the upper extremity artery by ultrasound [Day 1 after surgery]
Upper extremity artery thrombosis was assessed by ultrasonography after surgery
- Assessed stenosis in the upper extremity artery by ultrasound [Day 1 after surgery]
Upper extremity artery stenosis was assessed by ultrasonography after surgery
- Assessed occlusion in the upper extremity artery by ultrasound [Day 1 after surgery]
Upper extremity artery occlusion was assessed by ultrasonography after surgery
- Assess occlusion in the upper extremity artery by angiography or ultrasonography [Month 1 after surgery]
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 [Before the operation]
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 [Day 1 after surgery]
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. [Day 1 after surgery]
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. [Day 1 after surgery]
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) [Day 1 after surgery]
The incidence of postoperative cerebral infarction was evaluated by MRI，Including lacunar cerebral infarction.
- Evaluate the hemodynamic changes of upper limb vessels by ultrasound [Month 1 after the surgery]
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 (%).
Other Outcome Measures
- Calculate MEC50 and MEC95 of ropivacaine in brachial plexus block by sequential method [During the operation]
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.
- Record VAS score by questionnaire after the surgery [Day 0 after the surgery]
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.
- Record VAS score by questionnaire 24h after the surgery [Day 1 after the surgery]
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
- Record physician satisfaction by questionnaire [Day 0 after the surgery]
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.
- Record complications of brachial plexus block [Day 1 after the surgery]
The complications of brachial plexus block such as hematoma, infection, nerve injury were recorded after the surgery.
Eligibility Criteria
Criteria
Inclusion Criteria:
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18-75 years old, BMI<28kg/m2
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ASA physical status Ⅰ-Ⅲ
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Elective interventional surgery for intracranial aneurysms via TRA
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willing to sign informed consent
Exclusion Criteria:
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patients allergic to local anesthetics
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neck infection on the surgical side
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Preoperative upper extremity ultrasound or DSA showed radial artery occlusion and arteriovenous fistula
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The diameter of radial artery was still less than 2mm after brachial plexus block
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Axillary artery occlusion and other vascular anatomical abnormalities may affect the operation
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Radial artery patency: Barbeau type D
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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
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patients with incomplete block effect after nerve block were detected;
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The patient refused to participate in the study or cooperate with the follow-up
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The First Affiliated Hospital with Nanjing Medical University | Nanjing | Jiangsu | China | 210029 |
Sponsors and Collaborators
- The First Affiliated Hospital with Nanjing Medical University
- Xuzhou Central Hospital
- Huizhou Municipal Central Hospital
- The First People's Hospital of Changzhou
- Nanjing Jiangbei Hospital
Investigators
- Principal Investigator: Jingjin Li, MD, The First Affiliated Hospital with Nanjing Medical University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BPB