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Trial registered on ANZCTR
Registration number
ACTRN12621000588897
Ethics application status
Approved
Date submitted
18/05/2019
Date registered
18/05/2021
Date last updated
18/05/2021
Date data sharing statement initially provided
18/05/2021
Date results information initially provided
18/05/2021
Type of registration
Retrospectively registered
Titles & IDs
Public title
To evaluate tissue oxygen, tissue nutrition and blood value measured by measuring instrument without taking blood from the patient to evaluate the quality of nerve block performed in hand and arm surgeries performed in nerve block
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Scientific title
Evaluation of block quality using Near Infrared Spectroscopy (NIRS), Perfusion index (Pi) and Noninvasive monitoring of total hemoglobin (SpHB) in upper extremity surgery for infraclavicular block
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Secondary ID [1]
298280
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None
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Universal Trial Number (UTN)
U1111-1233-6937
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Upper extremity pathologies
312895
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Condition category
Condition code
Anaesthesiology
311381
311381
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0
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Other anaesthesiology
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Anaesthesiology
311382
311382
0
0
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Pain management
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Surgery
311383
311383
0
0
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Other surgery
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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
Various methods have been studied for objective evaluation of peripheral nerve block. The aim of this study was to investigate whether tissue oxygen saturation (StO2), tissue perfusion index (PI) and non-invasive total hemoglobin (SPHB) are reliable and objective methods for measuring the quality of the nerve block. StO2, PI and SPHBmeasurements will be made within 5 minutes of the first 30 minutes after the block. Measurements change over time after a successful infraclavicular block is obtained.
The InSpectraTM tissue spectrometer (Hutchinson technology, Hutchinson, MN, USA) is a novel non-invasive haemodynamic monitor. It utilises near infra-red spectroscopy (NIRS) technology to measure the proportion of oxygenated haemoglobin relative to total haemoglobin level in the tissue
Similarly The perfusion index (PI) and noninvasive blood hemoglobin, which are automatically measured by the pulse oximeter and are indicative of peripheral perfusion in the sensor region (finger), have been shown to be useful methods for evaluating the planned blocks in extremity surgery.
StO2, PI and SPHB were measured in 100 patients schedule for elective hand surgery under infraclavicular nerve block.
Non-invasive StO2-monitoring (InSpectraTM StO 2, Hutchinson Technology Inc., Hutchinson, Minnesota, USA), PI and SpHb (Upgradable rainbow SET™ Technology Platform) will use in patients before ultrasound guided infraclavicular plexus blockade and during the first 25 minute of the blockade in both hands.
The StO2 sensor will be place on the thenar muscle of the right hand in a position, which ensured an adequate total haemoglobin index (THI) of more than 5.0 according to the manufacturer recommendation. To measure tissue oxygen saturation near-infrared light (680–800 nm) is emitted into the thenar tissue with a depth of about 15 mm. In the light that is reflected from the tissue, the percentage of oxygenated haemoglobin is calculated by using the different absorption spectra of oxygenated and deoxygenated haemoglobin.
The probe to be used to measure the PI and SpHb (Upgradable SET ™ Technology Platform) will be placed on both the nerve block hand of the patient and the nail part of the middle finger of the unblocked hand and measurements will be taken. measurements will be recorded before block, during block and up to 25 minutes after block
infraclavicular blocks will perform using a 22-gauge stimulating needle under US guidance (Esaote My Lab 30 US gold machine, Florence, Italy) using in-plane approach.
The blocked and non-blocked arms will compare at precisely timed intervals. However, the duration of sensory block, the duration of motor block, side effects and complications Bromage scale for motor block and Pinprick test in the sensory block will be recorded.
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Intervention code [1]
314796
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Early Detection / Screening
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Comparator / control treatment
The blocked and non-blocked arms will compare at precisely timed intervals
The blocked arms compared non-blocked (control) arm .
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Control group
Active
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Outcomes
Primary outcome [1]
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Determine whether clinically available NIRS-based monitors could detect changes in tissue oxygen saturation following infraclavicular nerve blocks
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Assessment method [1]
320112
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Timepoint [1]
320112
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Noninvasive StO2 monitoring (InSpectra TM StO2, Hutchinson Technology Inc., Hutchinson, Minnesota, USA) will use in patients before ultrasound guided infraclavicular brachial plexus blockade and StO2 monitoring occurs every five minutes during the first 25 minute of the post block administration.
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Secondary outcome [1]
370555
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nil
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Assessment method [1]
370555
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Timepoint [1]
370555
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nil
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Eligibility
Key inclusion criteria
Patients undergoing elective upper limb surgery with ASA physical status I or II,
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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
contraindication to regional anesthesia, preexisting peripheral vascular disease or diabetes, an allergic reaction to local anesthetics, non-cooperative patients, patients with renal insufficiency, patients with hepatic impairment, pregnant and lactators, patients with ASA III-IV-V group and use of medications such as a- and b-blocking drugs.
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Study design
Purpose
Natural history
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Duration
Cross-sectional
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Selection
Defined population
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Timing
Prospective
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Statistical methods / analysis
We calculated the sample size according to the results of the first 15 patients in the study. From these differences and assuming a two-tailed a value of 0.05 (sensitivity 95%) and a ß value of 0.20 (study power: 80%, effect size: 0.80), we determined that at least 38 patients were required for our study by statistical software Package G Power (version 3.1.9.2; Franz Faul & Edgar Erdfelder, Trier, Germany). We decided to enroll 100 patients in this study
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
28/02/2019
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Date of last participant enrolment
Anticipated
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Actual
21/02/2020
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Date of last data collection
Anticipated
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Actual
21/08/2020
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Sample size
Target
100
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Accrual to date
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Final
100
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Recruitment outside Australia
Country [1]
23624
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Turkey
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State/province [1]
23624
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Sanliurfa
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Funding & Sponsors
Funding source category [1]
302821
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University
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Name [1]
302821
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Harran Üniversity
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Address [1]
302821
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Harran Üniversitesi Tip Fakültesi Arastirma ve Egitim Hastanesi osmanbey kampüsü Sanliurfa-Mardin Karayolu Uzeri 18.Km
Sanliurfa / Türkiye
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Country [1]
302821
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Turkey
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Primary sponsor type
University
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Name
Harran Üniversity
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Address
Harran Üniversitesi Tip Fakültesi Arastirma ve Egitim Hastanesi osmanbey kampüsü Sanliurfa-Mardin Karayolu Uzeri 18.Km
Sanliurfa / Türkiye
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Country
Turkey
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Secondary sponsor category [1]
302770
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None
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Name [1]
302770
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Address [1]
302770
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Country [1]
302770
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
303404
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harran üniversitesi
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Ethics committee address [1]
303404
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Harran Üniversitesi Tip Fakültesi Arastirma ve Egitim Hastanesi osmanbey kampüsü Sanliurfa-Mardin Karayolu Uzeri 18.Km
Sanliurfa / Türkiye
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Ethics committee country [1]
303404
0
Turkey
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Date submitted for ethics approval [1]
303404
0
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Approval date [1]
303404
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14/02/2019
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Ethics approval number [1]
303404
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Summary
Brief summary
Peripheral nerve block is a common technique of regional anesthesia. The traditional method to evaluate adequacy of the block for surgery is based on loss of sensory response to stimuli, which requires patient cooperation. After successful peripheral nerve blockade, local vasodilatation, increased local blood flow and increased skin temperature occur as a result of the blockade of sympathetic nerve fibers. However, in a busy operating room, these clinical signs do not appear fast enough to be used for clinical decision-making, particularly for con- firming the adequacy of a block before or during surgery. Several methods have been described for objective assessment of the nerve block. Near Infrared Spectroscopy (NIRS ) measures the differing absorption and reflection of near-infrared light transmitted by human tissues, which provides a tissue-oxygen saturation index. Similarly The perfusion index (PI) and noninvasive blood hemoglobin, which are automatically measured by the pulse oximeter and are indicative of peripheral perfusion in the sensor region (finger), have been shown to be useful methods for evaluating the planned blocks in extremity surgery. The primary objective of this study was to compare the success of the block with NIRS, Perfusion index (PI) and Noninvasive total hemoglobin monitoring (SPHB) in patients with upper extremity surgery for infraclavicular 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
93558
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Dr Abdulhakim Sengel
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Address
93558
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Harran Üniversitesi Tip Fakültesi Arastirma ve Egitim Hastanesi.
Sanliurfa-Mardin Karayolu Üzeri 18.Km
Sanliurfa / Türkiye
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Country
93558
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Turkey
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Phone
93558
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+905374030916
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Fax
93558
0
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Email
93558
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[email protected]
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Contact person for public queries
Name
93559
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Dr Abdulhakim Sengel
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Address
93559
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Harran Üniversitesi Tip Fakültesi Arastirma ve Egitim Hastanesi.
Sanliurfa-Mardin Karayolu Üzeri 18.Km
Sanliurfa / Türkiye
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Country
93559
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Turkey
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Phone
93559
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+905374030916
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Fax
93559
0
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Email
93559
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[email protected]
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Contact person for scientific queries
Name
93560
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Dr Abdulhakim Sengel
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Address
93560
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Harran Üniversitesi Tip Fakültesi Arastirma ve Egitim Hastanesi.
Sanliurfa-Mardin Karayolu Üzeri 18.Km
Sanliurfa / Türkiye
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Country
93560
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Turkey
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Phone
93560
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+905374030916
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Fax
93560
0
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Email
93560
0
[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
Comparison of the efficacy of five different objective methods to evaluate the success of infraclavicular block; which one of them is a reliable and early indicator?.
2023
https://dx.doi.org/10.14744/tjtes.2022.51289
N.B. These documents automatically identified may not have been verified by the study sponsor.
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