Intracranial AneurysmABPBCAETRANCT06035692
Application of Brachial Plexus Block in Patients Undergoing Cerebral Aneurysm Embolization Via Transradial Approach
A study testing Ropivacaine in people with Intracranial Aneurysm and Transradial Access(TRA), run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Intracranial Aneurysm, Transradial Access(TRA)
- What is being tested?
- Ropivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2023to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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 locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, 210029
Feng Feng, M.D, 13814073686, 316637881@qq.com
Nan Li, M.D, 15850647102, mzlinan2010@163.com
About this study
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
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.
Read the 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)
- Being tested
- Ropivacaine
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
Also called brachial plexus block
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.
| Study group | Role | What they receive |
|---|---|---|
| Brachial plexus block group（BPB） | Experimental | All patients received receive Ultrasound-guided BPB with 0.15% ropivacaine 20ml 30min before surgery Receives: Drug: Ropivacaine |
| Control group （Control） | No intervention | All patients received receive Ultrasound-guided BPB with normal saline 20ml 30min before surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the RAS by angiography at the begining of the operation
The RAS was assessed through radial artery angiography following the insertion of the arterial catheter.
Measured: During the operation
Evaluate the degree of RAS by angiography at the end of the operation
The severity of RAS was classified as severe, moderate, or mild based on the degree of stenosis observed on radial arteriography: greater than 75%, 25-75%, and less than 25% of the vessel diameter, respectively. In addition, if the combined spasm length exceeded 2cm, the severity increased by 1 grade.
Measured: During the operation
Secondary outcomes (22)
Assess unfavorable RA for repeated trans-radial interventions (TRI) at 1 month after surgery by ultrasonography.
The the radial artery was evaluated at 1 month after surgery using ultrasonography by an anesthesiologist who was blinded to the group assignments.The radial artery was considered unfavorable for repeated-TRI if it exhibited any of the following criteria: total occlusion, intima-media thickness (IMT) ≥0.5 mm and diameter <1.5mm, moderate and diffuse stenosis (> 10 mm in length), or severe focal or diffuse stenosis (regardless of length).
Measured: Month 1 after surgery
Record the incidence of intima-media thickness (IMT) ≥0.5 mm and diameter <1.5mm at 1 month after surgery by ultrasonography.
The incidence of intima-media thickness (IMT) ≥0.5 mm and diameter <1.5mm as a component of unfavorable RA for repeated TRI was recorded at one month follow-up.
Measured: Month 1 after surgery
Record the incidence of radial artery occlusion at 1 month after surgery by ultrasonography.
The incidence of radial artery occlusion as a component of unfavorable RA for repeated TRI was recorded at one month follow-up.
Measured: Month 1 after surgery
Record the incidence of moderate and diffuse stenosis (> 10 mm in length) at 1 month after surgery by ultrasonography.
The incidence of moderate and diffuse stenosis (> 10 mm in length) as a component of unfavorable RA for repeated TRI was recorded at one month follow-up.
Measured: Month 1 after surgery
Record the incidence of severe focal or diffuse stenosis (regardless of length) at 1 month after surgery by ultrasonography.
The incidence of severe focal or diffuse stenosis (regardless of length) as a component of unfavorable RA for repeated TRI was recorded at one month follow-up.
Measured: Month 1 after surgery
Record the use of nitroglycerin during the operation
When the radial sheath was inserted, upper limb angiography was performed, and nitroglycerin 200ug was administered if any degree of vasospasm in the upper limb was observed on the angiography. The administration of nitroglycerin in each group was recorded.
Measured: During the operation
Record the incidence of intraoperative hypotension
The definition of intraoperative hypotension was a mean arterial blood pressure below 60mmHg.
Measured: During the operation
Record physician satisfaction by questionnaire
Physician satisfaction was scored on a scale of 1-10, with a score of 1 indicating very poor and dissatisfied experience and a score of 10 indicating very satisfied. The surgeons were asked to fill in the satisfaction questionnaire according to the operation situation after operation and recorded.
Measured: Day 0 after the surgery
Record the duration of radial artery puncture
The time from the beginning of the radial artery puncture to the placement of the radial sheath was recorded.
Measured: At the begining of the operation
Measured diameter and the hemodynamic parameters of radial artery by ultrasound 30min after BPB or control interventions
The radial artery was evaluated(include diameter, PSV,EDV,TAMAX,PI,RI) before the surgery using ultrasonography by an anesthesiologist who was blinded to the group assignments.
Measured: 30min after BPB or control interventions
Measured diameter and the hemodynamic parameters of radial artery by ultrasound 24h after surgery
The radial artery was evaluated(include diameter, PSV,EDV,TAMAX,PI,RI) before the surgery using ultrasonography by an anesthesiologist who was blinded to the group assignments.
Measured: 24h after surgery
Measured diameter and the hemodynamic parameters of radial artery by ultrasound 1 month after surgery
The radial artery was evaluated(include diameter, PSV,EDV,TAMAX,PI,RI) before the surgery using ultrasonography by an anesthesiologist who was blinded to the group assignments.
Measured: Month 1 after surgery
Measured diameter and the hemodynamic parameters of ulnar artery by ultrasound 30min after BPB or control interventions
The ulnar artery was evaluated(include diameter, PSV,EDV,TAMAX,PI,RI) before the surgery using ultrasonography by an anesthesiologist who was blinded to the group assignments.
Measured: 30min after BPB or control interventions
Measured diameter and the hemodynamic parameters of ulnar artery by ultrasound 24h after surgery
The ulnar artery was evaluated(include diameter, PSV,EDV,TAMAX,PI,RI) before the surgery using ultrasonography by an anesthesiologist who was blinded to the group assignments.
Measured: 24h after surgery
Measured diameter and the hemodynamic parameters of ulnar artery by ultrasound 1 month after surgery
The ulnar artery was evaluated(include diameter, PSV,EDV,TAMAX,PI,RI) before the surgery using ultrasonography by an anesthesiologist who was blinded to the group assignments.
Measured: Month 1 after surgery
Measured diameter and the hemodynamic parameters of brachial artery by ultrasound 30min after BPB or control interventions
The brachial artery was evaluated(include diameter, PSV,EDV,TAMAX,PI,RI) before the surgery using ultrasonography by an anesthesiologist who was blinded to the group assignments.
Measured: 30min after BPB or control interventions
Measured diameter and the hemodynamic parameters of brachial artery by ultrasound 24h after surgery
The brachial artery was evaluated(include diameter, PSV,EDV,TAMAX,PI,RI) before the surgery using ultrasonography by an anesthesiologist who was blinded to the group assignments.
Measured: 24h after surgery
Measured diameter and the hemodynamic parameters of brachial artery by ultrasound 1 month after surgery
The brachial artery was evaluated(include diameter, PSV,EDV,TAMAX,PI,RI) before the surgery using ultrasonography by an anesthesiologist who was blinded to the group assignments.
Measured: Month 1 after surgery
Record mean arterial pressure at different time points
The mean intraoperative arterial pressure from T0 to T8 was recorded. T0 indicates time after entering the operating room; T1,30 minutes after BPB or control procedure; T2, 5 minutes after induction of general anesthesia; T3, angiography after the radial sheath enters the radial artery; T4,1minutes after angiography; T5, 3minutes after angiography; T6, 5minutes after angiography; T7, 10 minutes after angiography; T8, completion of the operation.
Measured: During the operation
Record perioperative complications
Perioperative complications include puncture site complications, brachial plexus complications, and other cardiovascular and cerebrovascular complications
Measured: Day 1 after the surgery
Recorded the levels of eight inflammatory factors
The hospital laboratory conducted an examination on 8 inflammatory factors (include IL-2,IL-4,IL-6,IL-10,IL-17,IL-12P70,IFN-r,TNF-a) to assess postoperative infection, and subsequently provided the results.
Measured: Day 1 after the surgery
Recorded the incidence of postoperative acute embolism events
A head magnetic resonance imaging(MRI) was conducted to document the occurrence of postoperative embolic events, such as acute cerebral infarction.
Measured: Day 1 after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start1 Jun 2023
- Primary completion29 Feb 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial AneurysmStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Xuzhou Central Hospital, Huizhou Municipal Central Hospital, Nanjing Jiangbei Hospital
- Responsible party
- Sponsor
- Investigators
- Jingjin Li, M.D, Principal investigator, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06035692
- Sponsor's protocol ID
- BPB
- Acronym
- ABPBCAETRA
- Status last verified
- Feb 2024
- First submitted
- 27 Jun 2023
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: If anyone is interested in this study, please contact us, and I think we would like to share IPD with him
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06035692
- Acronym / sponsor ID
- ABPBCAETRA / BPB
- Conditions
- Intracranial Aneurysm, Transradial Access(TRA)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- Xuzhou Central Hospital, Huizhou Municipal Central Hospital, Nanjing Jiangbei Hospital
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 29 Feb 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 13 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Brachial plexus block group（BPB） | Experimental | Drug: RopivacaineAll patients received receive Ultrasound-guided BPB with 0.15% ropivacaine 20ml 30min before surgery |
| Control group （Control） | No intervention | –All patients received receive Ultrasound-guided BPB with normal saline 20ml 30min before surgery |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RopivacaineAlso: brachial plexus blockAccording 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. | Drug | Brachial plexus block group（BPB） |
Primary outcome
Assess the RAS by angiography at the begining of the operation
Time frame: During the operation
The RAS was assessed through radial artery angiography following the insertion of the arterial catheter.
Evaluate the degree of RAS by angiography at the end of the operation
Time frame: During the operation
The severity of RAS was classified as severe, moderate, or mild based on the degree of stenosis observed on radial arteriography: greater than 75%, 25-75%, and less than 25% of the vessel diameter, respectively. In addition, if the combined spasm length exceeded 2cm, the severity increased by 1 grade.
22 secondary outcomes
Assess unfavorable RA for repeated trans-radial interventions (TRI) at 1 month after surgery by ultrasonography.
Time frame: Month 1 after surgery
Record the incidence of intima-media thickness (IMT) ≥0.5 mm and diameter <1.5mm at 1 month after surgery by ultrasonography.
Time frame: Month 1 after surgery
Record the incidence of radial artery occlusion at 1 month after surgery by ultrasonography.
Time frame: Month 1 after surgery
Record the incidence of moderate and diffuse stenosis (> 10 mm in length) at 1 month after surgery by ultrasonography.
Time frame: Month 1 after surgery
Record the incidence of severe focal or diffuse stenosis (regardless of length) at 1 month after surgery by ultrasonography.
Time frame: Month 1 after surgery
Record the use of nitroglycerin during the operation
Time frame: During the operation
Record the incidence of intraoperative hypotension
Time frame: During the operation
Record physician satisfaction by questionnaire
Time frame: Day 0 after the surgery
Record the duration of radial artery puncture
Time frame: At the begining of the operation
Measured diameter and the hemodynamic parameters of radial artery by ultrasound 30min after BPB or control interventions
Time frame: 30min after BPB or control interventions
Measured diameter and the hemodynamic parameters of radial artery by ultrasound 24h after surgery
Time frame: 24h after surgery
Measured diameter and the hemodynamic parameters of radial artery by ultrasound 1 month after surgery
Time frame: Month 1 after surgery
Measured diameter and the hemodynamic parameters of ulnar artery by ultrasound 30min after BPB or control interventions
Time frame: 30min after BPB or control interventions
Measured diameter and the hemodynamic parameters of ulnar artery by ultrasound 24h after surgery
Time frame: 24h after surgery
Measured diameter and the hemodynamic parameters of ulnar artery by ultrasound 1 month after surgery
Time frame: Month 1 after surgery
Measured diameter and the hemodynamic parameters of brachial artery by ultrasound 30min after BPB or control interventions
Time frame: 30min after BPB or control interventions
Measured diameter and the hemodynamic parameters of brachial artery by ultrasound 24h after surgery
Time frame: 24h after surgery
Measured diameter and the hemodynamic parameters of brachial artery by ultrasound 1 month after surgery
Time frame: Month 1 after surgery
Record mean arterial pressure at different time points
Time frame: During the operation
Record perioperative complications
Time frame: Day 1 after the surgery
Recorded the levels of eight inflammatory factors
Time frame: Day 1 after the surgery
Recorded the incidence of postoperative acute embolism events
Time frame: Day 1 after the surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Individual participant dataSharing planned: Yes. If anyone is interested in this study, please contact us, and I think we would like to share IPD with him
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jingjin Li, M.D principal investigator
The First Affiliated Hospital with Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ropivacaine in people with Intracranial Aneurysm and Transradial Access(TRA), run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Feng Feng, M.D (13814073686, 316637881@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the RAS by angiography at the begining of the operation (time frame: During the operation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.