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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
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
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
Secondary ID [1] 298280 0
None
Universal Trial Number (UTN)
U1111-1233-6937
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Upper extremity pathologies 312895 0
Condition category
Condition code
Anaesthesiology 311381 311381 0 0
Other anaesthesiology
Anaesthesiology 311382 311382 0 0
Pain management
Surgery 311383 311383 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
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 SETâ„¢ 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 â„¢ 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.
Intervention code [1] 314796 0
Early Detection / Screening
Comparator / control treatment
The blocked and non-blocked arms will compare at precisely timed intervals

The blocked arms compared non-blocked (control) arm .
Control group
Active

Outcomes
Primary outcome [1] 320112 0
Determine whether clinically available NIRS-based monitors could detect changes in tissue oxygen saturation following infraclavicular nerve blocks
Timepoint [1] 320112 0
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.
Secondary outcome [1] 370555 0
nil
Timepoint [1] 370555 0
nil

Eligibility
Key inclusion criteria
Patients undergoing elective upper limb surgery with ASA physical status I or II,
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
28/02/2019
Date of last participant enrolment
Anticipated
Actual
21/02/2020
Date of last data collection
Anticipated
Actual
21/08/2020
Sample size
Target
100
Accrual to date
Final
100
Recruitment outside Australia
Country [1] 23624 0
Turkey
State/province [1] 23624 0
Sanliurfa

Funding & Sponsors
Funding source category [1] 302821 0
University
Name [1] 302821 0
Harran Üniversity
Country [1] 302821 0
Turkey
Primary sponsor type
University
Name
Harran Üniversity
Address
Harran Üniversitesi Tip Fakültesi Arastirma ve Egitim Hastanesi osmanbey kampüsü Sanliurfa-Mardin Karayolu Uzeri 18.Km
Sanliurfa / Türkiye
Country
Turkey
Secondary sponsor category [1] 302770 0
None
Name [1] 302770 0
Address [1] 302770 0
Country [1] 302770 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303404 0
harran üniversitesi
Ethics committee address [1] 303404 0
Ethics committee country [1] 303404 0
Turkey
Date submitted for ethics approval [1] 303404 0
Approval date [1] 303404 0
14/02/2019
Ethics approval number [1] 303404 0

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

Contacts
Principal investigator
Name 93558 0
Dr Abdulhakim Sengel
Address 93558 0
Harran Üniversitesi Tip Fakültesi Arastirma ve Egitim Hastanesi.
Sanliurfa-Mardin Karayolu Üzeri 18.Km
Sanliurfa / Türkiye
Country 93558 0
Turkey
Phone 93558 0
+905374030916
Fax 93558 0
Email 93558 0
ahsengel121@gmail.com
Contact person for public queries
Name 93559 0
Abdulhakim Sengel
Address 93559 0
Harran Üniversitesi Tip Fakültesi Arastirma ve Egitim Hastanesi.
Sanliurfa-Mardin Karayolu Üzeri 18.Km
Sanliurfa / Türkiye
Country 93559 0
Turkey
Phone 93559 0
+905374030916
Fax 93559 0
Email 93559 0
ahsengel121@gmail.com
Contact person for scientific queries
Name 93560 0
Abdulhakim Sengel
Address 93560 0
Harran Üniversitesi Tip Fakültesi Arastirma ve Egitim Hastanesi.
Sanliurfa-Mardin Karayolu Üzeri 18.Km
Sanliurfa / Türkiye
Country 93560 0
Turkey
Phone 93560 0
+905374030916
Fax 93560 0
Email 93560 0
ahsengel121@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
EmbaseComparison 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?.2023https://dx.doi.org/10.14744/tjtes.2022.51289
N.B. These documents automatically identified may not have been verified by the study sponsor.