Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000688381
Ethics application status
Approved
Date submitted
11/04/2017
Date registered
12/05/2017
Date last updated
21/10/2021
Date data sharing statement initially provided
21/10/2021
Date results information initially provided
21/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Tissue oxygen saturation change on upper extremities after ultrasound guided infraclavicular brachial plexus blockade.
Scientific title
Tissue oxygen saturation change on upper extremities after ultrasound guided infraclavicular brachial plexus blockade; Prospective observational study
Secondary ID [1] 291095 0
None
Universal Trial Number (UTN)
U1111-1168-3483
Trial acronym
TOUGIB
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Upper extremity pathologies 301940 0
Condition category
Condition code
Anaesthesiology 301591 301591 0 0
Other anaesthesiology
Anaesthesiology 301653 301653 0 0
Pain management
Surgery 302499 302499 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
Several methods were studied for objective assessment of the peripheral nerve block. The aim of the study will investigate whether tissue oxygen saturation (StO2), a measure of the proportion of oxygenated haemoglobin relative to total haemoglobin level in the tissue, is a reliable and objective method for assessing the adequacy of infraclavicular blockade and to describe the time course of StO2 changes once peripheral nerve block has been achieved during surgery.

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

StO 2 was measured in 40 patients schedule for elective hand surgery under infraclavicular nerve block. Non-invasive StO 2-monitoring (InSpectraTM StO 2, Hutchinson Technology Inc., Hutchinson, Minnesota, USA) will use in patients before ultrasound guided infraclavicular plexus blockade and during the first 30 minute of the blockade in both hands.

The StO 2 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.

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] 297918 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] 301020 0
Determine whether clinically available NIRS-based monitors could detect changes in tissue oxygen saturation following infraclavicular nerve blocks
Timepoint [1] 301020 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 30 minute of the post block administration.
Secondary outcome [1] 331479 0
Modified Bromage Scale for motor block anesthesia will use.
Timepoint [1] 331479 0
every 5 minutes during the first 30 minute of the blockade
Secondary outcome [2] 334266 0
pinprick test for sensory anesthesia will use.
Timepoint [2] 334266 0
every 5 minutes during the first 30 minute of the blockade

Eligibility
Key inclusion criteria
Patients undergoing elective upper limb surgery with ASA physical status I or II, aged between 18 and 65 years
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 and use of medications such as a- and b-blocking drugs.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/05/2017
Actual
22/05/2017
Date of last participant enrolment
Anticipated
15/06/2017
Actual
26/06/2017
Date of last data collection
Anticipated
20/06/2017
Actual
23/10/2017
Sample size
Target
40
Accrual to date
Final
40
Recruitment outside Australia
Country [1] 8652 0
Turkey
State/province [1] 8652 0
sanliurfa

Funding & Sponsors
Funding source category [1] 295535 0
University
Name [1] 295535 0
Harran University
Country [1] 295535 0
Turkey
Primary sponsor type
Hospital
Name
Harran University School of Medicine, Research and Training Hospital
Address
Harran University School of Medicine, Research and Training Hospital osmanbey campus Sanliurfa-Mardin Karayolu Uzeri 18.Km
Sanliurfa/Turkey
Country
Turkey
Secondary sponsor category [1] 294353 0
None
Name [1] 294353 0
Address [1] 294353 0
Country [1] 294353 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296856 0
harran universty
Ethics committee address [1] 296856 0
Ethics committee country [1] 296856 0
Turkey
Date submitted for ethics approval [1] 296856 0
Approval date [1] 296856 0
06/04/2017
Ethics approval number [1] 296856 0

Summary
Brief summary
Several methods were studied for objective assessment of the peripheral nerve block. The aim of the study will investigate whether tissue oxygen saturation (StO2), a measure of the proportion of oxygenated haemoglobin relative to total haemoglobin level in the tissue, is a reliable and objective method for assessing the adequacy of infraclavicular blockade and to describe the time course of StO2 changes once peripheral nerve block has been achieved during surgery.
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
In this study, StO 2 will measure in 40 patients schedule for elective hand surgery under infraclavicular nerve block. Non-invasive StO 2-monitoring (InSpectraTM StO 2, Hutchinson Technology Inc., Hutchinson, Minnesota, USA) will use in patients before ultrasound guided infraclavicular plexus blockade and during the first 30 minute of the blockade in both hands.

The StO 2 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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 72238 0
A/Prof Mahmut Alp Karahan
Address 72238 0
Harran University School of Medicine, Research and Training Hospital.
Sanliurfa-Mardin Karayolu Üzeri 18.Km
Sanliurfa/Turkey
Country 72238 0
Turkey
Phone 72238 0
+905327808997
Fax 72238 0
Email 72238 0
[email protected]
Contact person for public queries
Name 72239 0
A/Prof Mahmut Alp Karahan
Address 72239 0
Harran University School of Medicine, Research and Training Hospital.
Sanliurfa-Mardin Karayolu Üzeri 18.Km
Sanliurfa/Turkey
Country 72239 0
Turkey
Phone 72239 0
+905327808997
Fax 72239 0
Email 72239 0
[email protected]
Contact person for scientific queries
Name 72240 0
A/Prof Mahmut Alp Karahan
Address 72240 0
Harran University School of Medicine, Research and Training Hospital.
Sanliurfa-Mardin Karayolu Üzeri 18.Km
Sanliurfa/Turkey
Country 72240 0
Turkey
Phone 72240 0
+905327808997
Fax 72240 0
Email 72240 0
[email protected]

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
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Karahan MA, Binici O, Büyükfirat E. Tissue Oxygen ... [More Details] 372295-(Uploaded-04-05-2021-23-12-32)-Journal results publication.pdf

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AITissue Oxygen Saturation Change on Upper Extremities After Ultrasound-Guided Infraclavicular Brachial Plexus Blockade; Prospective Observational Study2019https://doi.org/10.3390/medicina55060274
N.B. These documents automatically identified may not have been verified by the study sponsor.