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Trial registered on ANZCTR
Registration number
ACTRN12619000360112
Ethics application status
Approved
Date submitted
20/02/2019
Date registered
6/03/2019
Date last updated
6/03/2019
Date data sharing statement initially provided
6/03/2019
Type of registration
Prospectively registered
Titles & IDs
Public title
The hemodynamic changes after brachial plexus block
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Scientific title
The hemodynamic changes in brachial artery after infraclavicular brachial plexus block in early and late period.
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Secondary ID [1]
297459
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None
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Universal Trial Number (UTN)
U1111-1228-8942
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Trial acronym
BBH (Brachial plexus block hemodynamics)
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Linked study record
No
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Health condition
Health condition(s) or problem(s) studied:
elective upper extremity operation
311644
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Condition category
Condition code
Anaesthesiology
310268
310268
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0
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Other anaesthesiology
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
The patients who will receive an infraclavicular nerve block for upper extremity surgery, will be included into the study. All patients will undergo the nerve block in the absence of this study. The Doppler Ultrasound measurements will be taken at 6 different timepoints in all patients; (T0) before the nerve block, (T1) 5 minutes after the nerve block, (T2) 15 minutes after the nerve block, (T3) 30 minutes after the nerve block, (T4) 24 hours after the nerve block, (T5) 48 hours after the nerve block. At every time points the diameter of brachial artery, the Volume Flow, systolic velocity (PSV, cm/s), enddiastolic velocity (EDV, cm/s), mean velocity (Vmean, cm/s), timeaveraged mean velocity (TAVM, cm/s), ratio of PSV and EDV (S/D), resistance index (RI), and pulsatility index (PI) will be measured. The onset time of sensorial block and motor block will be recorded.
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Intervention code [1]
313713
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Early Detection / Screening
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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The Brachial artery Volume Flow measurement by using Doppler USG
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Assessment method [1]
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Timepoint [1]
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5 minutes before, 5 minutes, 15 minutes, 30 minutes, 24 hours and 48 hours after nerve block.
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Primary outcome [2]
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the diameter of brachial artery measurement by using Doppler USG
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Assessment method [2]
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Timepoint [2]
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5 minutes before,5 minutes,15 minutes,30minutes,24 hours and 48 hours after nerve block.
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Secondary outcome [1]
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The systolic velocity (PSV, cm/s) measurement by using Doppler USG
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Assessment method [1]
367146
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Timepoint [1]
367146
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5 minutes before,5 minutes,15 minutes,30minutes,24 hours and 48 hours after nerve block.
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Secondary outcome [2]
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enddiastolic velocity (EDV, cm/s) measurement by using Doppler USG
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Assessment method [2]
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Timepoint [2]
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5 minutes before,5 minutes,15 minutes,30minutes,24 hours and 48 hours after nerve block.
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Secondary outcome [3]
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mean velocity (Vmean, cm/s) measurement by using Doppler USG
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Assessment method [3]
367700
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Timepoint [3]
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5 minutes before,5 minutes,15 minutes,30minutes,24 hours and 48 hours after nerve block.
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Secondary outcome [4]
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timeaveraged mean velocity (TAVM, cm/s) measurement by using Doppler USG
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Assessment method [4]
367701
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Timepoint [4]
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5 minutes before,5 minutes,15 minutes,30minutes,24 hours and 48 hours after nerve block.
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Secondary outcome [5]
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ratio of PSV and EDV (S/D) measurement by using Doppler USG
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Assessment method [5]
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Timepoint [5]
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5 minutes before,5 minutes,15 minutes,30minutes,24 hours and 48 hours after nerve block.
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Secondary outcome [6]
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resistance index (RI) measurement by using Doppler USG
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Assessment method [6]
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Timepoint [6]
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5 minutes before,5 minutes,15 minutes,30minutes,24 hours and 48 hours after nerve block.
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Secondary outcome [7]
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pulsatility index (PI) measurement by using Doppler USG
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Assessment method [7]
367778
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Timepoint [7]
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5 minutes before,5 minutes,15 minutes,30minutes,24 hours and 48 hours after nerve block.
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Secondary outcome [8]
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sensorial block by using pinprick test
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Assessment method [8]
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Timepoint [8]
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after nerve block at every 5 minutes in the 30 minutes
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Secondary outcome [9]
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motor block after nerve block by using modified bromage scale
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Assessment method [9]
367780
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Timepoint [9]
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after nerve block at every 5 minutes in the 30 minutes
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Eligibility
Key inclusion criteria
1) 18-65 years old
2) ASA I-II
3) Patient's who will be operated for elective upper extremity operation
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1) known allergy to local anesthetic drugs
2) the presence of connective tissue disease
3) neurological or muscle disorders
4) skin infection at the axillary area
5) cardiovascular diseases
6) diabetes mellitus
7) autonomic neuropathy
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Study design
Purpose
Screening
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Duration
Longitudinal
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Selection
Convenience sample
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Timing
Prospective
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Statistical methods / analysis
Sample size will be calculated using the data obtained by the pilot study which will be conducted initially with 8 patients in total. Based on the proposed hypotheses which expect the 50% decrease on the Volume Flow between time 30.minutes to time 24 hours, The required sample size will be estimated with and an assumption of type I error of 0.01, along with type II error of 0.10 which brings a power of 0.90 (1- ß). Shapes of the distributions of the measured variables will be demonstrated by using Shapiro-Wilk method. T-test will be used to compare gender differences on the outcome parameters, and detailed with mean±standard deviation. Since the measurements wiil be rated by two independent raters including an anaesthesiologist and a radiologist, thus, the reliability tests will be utilised to assess the inter-rater agreement between the ratings of the outcomes. Intra-class correlation coefficient (ICC) will be chosen as an appropriate coefficient and will be calculated with two-way random affect model with an absolute agreement. Agreement coefficients will be reported along with 95% confidence intervals, and considered the ICC values > 0.90 as a very good agreement between the raters on the measurement. The measured parameters will be collected over the time starting from time the baseline measurement to the time the 48 hours. The repeated measures analysis of variance will be conducted between the time 30th.min to time 24th hours, Taking steps further with repeated measures, Posthoc analyses will be performed using Bonferroni correction for pairwise comparisons since within-subject variation in overall model. Statistical analyses will be conducted using SPSS version 25 (made by SPSS Incorporated, located in Chicago, Illinois, USA). P values of < 0.05 will be considered as significant for the tests results.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
8/03/2019
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Actual
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Date of last participant enrolment
Anticipated
8/04/2019
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Actual
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Date of last data collection
Anticipated
10/04/2019
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Actual
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Sample size
Target
18
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
21291
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Turkey
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State/province [1]
21291
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Mugla
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Funding & Sponsors
Funding source category [1]
302029
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Hospital
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Name [1]
302029
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Mugla Sitki Koçman University Training and Research Hospital
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Address [1]
302029
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Mugla Sitki Koçman Üniversitesi Egitim Arastirma Hastanesi Marmaris Yolu M kapisi karsisi Kötekli Mahallesi 48000 MUGLA
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Country [1]
302029
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Turkey
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Primary sponsor type
Individual
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Name
Ali Ihsan Uysal
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Address
Mugla Sitki Koçman Üniversitesi Egitim Arastirma Hastanesi Marmaris Yolu M kapisi karsisi Kötekli Mahallesi 48000 MUGLA
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Country
Turkey
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Secondary sponsor category [1]
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None
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Name [1]
301825
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Address [1]
301825
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Country [1]
301825
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
302709
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Mugla Sitki Koçman University Training and Research Hospital Institutional Ethics Committee
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Ethics committee address [1]
302709
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Mugla Sitki Koçman Üniversitesi Egitim Arastirma Hastanesi Marmaris Yolu M kapisi karsisi Kötekli Mahallesi 48000 MUGLA
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Ethics committee country [1]
302709
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Turkey
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Date submitted for ethics approval [1]
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03/12/2018
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Approval date [1]
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07/01/2019
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Ethics approval number [1]
302709
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Decision number: 3612
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Summary
Brief summary
The primary aim of this study is to evaluate the hemodynamic changes after infraclavicular brachial plexus block in early and late period buy using Doppler ultrasound. The secondary aim is to evaluate the relationship between sympathetic, sensorial and motor block in brachial plexus block.
The hypothesis of our study is the changes in Volume Flow after brachial nerve block can help us for evaluating sympathetic nerve block.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
91126
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Dr Ali Ihsan Uysal
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Address
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Mugla Sitki Koçman Üniversitesi Egitim Arastirma Hastanesi Marmaris Yolu M kapisi karsisi Kötekli Mahallesi 48000 MUGLA
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Country
91126
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Turkey
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Phone
91126
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+905067020960
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Fax
91126
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Email
91126
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[email protected]
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Contact person for public queries
Name
91127
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Dr Ali Ihsan Uysal
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Address
91127
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Mugla Sitki Koçman Üniversitesi Egitim Arastirma Hastanesi Marmaris Yolu M kapisi karsisi Kötekli Mahallesi 48000 MUGLA
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Country
91127
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Turkey
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Phone
91127
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+905067020960
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Fax
91127
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Email
91127
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[email protected]
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Contact person for scientific queries
Name
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Dr Ali Ihsan Uysal
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Address
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Mugla Sitki Koçman Üniversitesi Egitim Arastirma Hastanesi Marmaris Yolu M kapisi karsisi Kötekli Mahallesi 48000 MUGLA
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Country
91128
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Turkey
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Phone
91128
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+905067020960
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Fax
91128
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Email
91128
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
Early and late blood flow changes in the brachial artery following brachial plexus block.
2020
https://dx.doi.org/10.23736/S0375-9393.20.14309-8
N.B. These documents automatically identified may not have been verified by the study sponsor.
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