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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
Scientific title
The hemodynamic changes in brachial artery after infraclavicular brachial plexus block in early and late period.
Secondary ID [1] 297459 0
None
Universal Trial Number (UTN)
U1111-1228-8942
Trial acronym
BBH (Brachial plexus block hemodynamics)
Linked study record
No

Health condition
Health condition(s) or problem(s) studied:
elective upper extremity operation 311644 0
Condition category
Condition code
Anaesthesiology 310268 310268 0 0
Other anaesthesiology

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 313713 0
Early Detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 319160 0
The Brachial artery Volume Flow measurement by using Doppler USG
Timepoint [1] 319160 0
5 minutes before, 5 minutes, 15 minutes, 30 minutes, 24 hours and 48 hours after nerve block.
Primary outcome [2] 319161 0
the diameter of brachial artery measurement by using Doppler USG
Timepoint [2] 319161 0
5 minutes before,5 minutes,15 minutes,30minutes,24 hours and 48 hours after nerve block.
Secondary outcome [1] 367146 0
The systolic velocity (PSV, cm/s) measurement by using Doppler USG
Timepoint [1] 367146 0
5 minutes before,5 minutes,15 minutes,30minutes,24 hours and 48 hours after nerve block.
Secondary outcome [2] 367699 0
enddiastolic velocity (EDV, cm/s) measurement by using Doppler USG
Timepoint [2] 367699 0
5 minutes before,5 minutes,15 minutes,30minutes,24 hours and 48 hours after nerve block.
Secondary outcome [3] 367700 0
mean velocity (Vmean, cm/s) measurement by using Doppler USG
Timepoint [3] 367700 0
5 minutes before,5 minutes,15 minutes,30minutes,24 hours and 48 hours after nerve block.
Secondary outcome [4] 367701 0
timeaveraged mean velocity (TAVM, cm/s) measurement by using Doppler USG
Timepoint [4] 367701 0
5 minutes before,5 minutes,15 minutes,30minutes,24 hours and 48 hours after nerve block.
Secondary outcome [5] 367776 0
ratio of PSV and EDV (S/D) measurement by using Doppler USG
Timepoint [5] 367776 0
5 minutes before,5 minutes,15 minutes,30minutes,24 hours and 48 hours after nerve block.
Secondary outcome [6] 367777 0
resistance index (RI) measurement by using Doppler USG
Timepoint [6] 367777 0
5 minutes before,5 minutes,15 minutes,30minutes,24 hours and 48 hours after nerve block.
Secondary outcome [7] 367778 0
pulsatility index (PI) measurement by using Doppler USG
Timepoint [7] 367778 0
5 minutes before,5 minutes,15 minutes,30minutes,24 hours and 48 hours after nerve block.
Secondary outcome [8] 367779 0
sensorial block by using pinprick test
Timepoint [8] 367779 0
after nerve block at every 5 minutes in the 30 minutes
Secondary outcome [9] 367780 0
motor block after nerve block by using modified bromage scale
Timepoint [9] 367780 0
after nerve block at every 5 minutes in the 30 minutes

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
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
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.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
8/03/2019
Actual
Date of last participant enrolment
Anticipated
8/04/2019
Actual
Date of last data collection
Anticipated
10/04/2019
Actual
Sample size
Target
18
Accrual to date
Final
Recruitment outside Australia
Country [1] 21291 0
Turkey
State/province [1] 21291 0
Mugla

Funding & Sponsors
Funding source category [1] 302029 0
Hospital
Name [1] 302029 0
Mugla Sitki Koçman University Training and Research Hospital
Country [1] 302029 0
Turkey
Primary sponsor type
Individual
Name
Ali Ihsan Uysal
Address
Mugla Sitki Koçman Üniversitesi Egitim Arastirma Hastanesi Marmaris Yolu M kapisi karsisi Kötekli Mahallesi 48000 MUGLA
Country
Turkey
Secondary sponsor category [1] 301825 0
None
Name [1] 301825 0
Address [1] 301825 0
Country [1] 301825 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302709 0
Mugla Sitki Koçman University Training and Research Hospital Institutional Ethics Committee
Ethics committee address [1] 302709 0
Ethics committee country [1] 302709 0
Turkey
Date submitted for ethics approval [1] 302709 0
03/12/2018
Approval date [1] 302709 0
07/01/2019
Ethics approval number [1] 302709 0
Decision number: 3612

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91126 0
Dr Ali Ihsan Uysal
Address 91126 0
Mugla Sitki Koçman Üniversitesi Egitim Arastirma Hastanesi Marmaris Yolu M kapisi karsisi Kötekli Mahallesi 48000 MUGLA
Country 91126 0
Turkey
Phone 91126 0
+905067020960
Fax 91126 0
Email 91126 0
alihsanuysal@gmail.com
Contact person for public queries
Name 91127 0
Ali Ihsan Uysal
Address 91127 0
Mugla Sitki Koçman Üniversitesi Egitim Arastirma Hastanesi Marmaris Yolu M kapisi karsisi Kötekli Mahallesi 48000 MUGLA
Country 91127 0
Turkey
Phone 91127 0
+905067020960
Fax 91127 0
Email 91127 0
alihsanuysal@gmail.com
Contact person for scientific queries
Name 91128 0
Ali Ihsan Uysal
Address 91128 0
Mugla Sitki Koçman Üniversitesi Egitim Arastirma Hastanesi Marmaris Yolu M kapisi karsisi Kötekli Mahallesi 48000 MUGLA
Country 91128 0
Turkey
Phone 91128 0
+905067020960
Fax 91128 0
Email 91128 0
alihsanuysal@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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
SourceTitleYear of PublicationDOI
EmbaseEarly and late blood flow changes in the brachial artery following brachial plexus block.2020https://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.