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Trial registered on ANZCTR


Registration number
ACTRN12616000656437
Ethics application status
Approved
Date submitted
5/05/2016
Date registered
19/05/2016
Date last updated
26/11/2018
Date data sharing statement initially provided
26/11/2018
Date results information initially provided
26/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Distal skin temperature and tissue oxygen saturation for predicting ultrasound-guided lateral infraclavicular block success
Scientific title
Evaluation of distal skin temperature and tissue oxygen saturation determined by near-infrared spectroscopy for predicting ultrasound-guided lateral infraclavicular block success
Secondary ID [1] 289145 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Forearm surgery 298658 0
Condition category
Condition code
Anaesthesiology 298720 298720 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
Forty patients between the ages of 18-65 yr, ASA physical status I and II, scheduled for acute or elective hand or forearm surgery under lateral infraclavicular block, will studied.Routine monitoring (consisting of a pulse oximeter, 3-lead ECG and a non-invasive blood pressure cuff ) will applied. In addition to this monitoring two near infrared spectroscopy sensors which will monitor tissue saturation (SomaSensors, Somanetics, Troy, MI) will be placed on each patient: One on the side of the peripheral nerve block and another at a similar site on the contralateral side.Each sensor will be placed on a different arm.The sensor will be placed on the the ventral aspect of the mid-forearm. The sensors will connected to a two channel monitor (Invos 5100B monitor, Somanetics), which automatically recorded digital data approximately every 7 s for a maximum of 30 min.Sensors record every 7 seconds for 30 minutes starting immediately prior to the administration of the block.
Intervention code [1] 294750 0
Early Detection / Screening
Comparator / control treatment
Control group is the contralateral hand (the hand receiving no block).
Control group
Active

Outcomes
Primary outcome [1] 298197 0
Tissue oxygen saturation assesment by near-infrared spectroscopy
Timepoint [1] 298197 0
A blind anesthesia nurse, recorded both sides tissue oxygen saturation values from the monitor at baseline, immediately after LIB and 1 min intervals for 30 min, starting immediately after performing LIB.
Secondary outcome [1] 323458 0
Skin temperature assessment by skin temperature sensors.
Timepoint [1] 323458 0
A blind anesthesia nurse, recorded both sides skin temperature at baseline, immediately after LIB and 1 min intervals for 30 min, starting immediately after performing LIB.

Eligibility
Key inclusion criteria
18-65 yr, ASA physical status I and II, scheduled for acute or elective hand or forearm surgery under lateral infraclavicular block
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Age less than 18 years, morbid obesity defined as body mass index (BMI) greater than 40, international normalised ratio more than 1.4, platelet count less than 80000 ,coagulopathy, medication with vitamin K antagonists, high-dose or fractionated heparin treatment, allergy to local anaesthetics, infection at the site of needle insertion, peripheral neurological disease, Raynaud’s phenomenon and patient refusal.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 7859 0
Turkey
State/province [1] 7859 0
Konya

Funding & Sponsors
Funding source category [1] 293521 0
Hospital
Name [1] 293521 0
Konya Training and Research Hospital
Address [1] 293521 0
Konya Training and Research Hospital, Haci Saban Mah. Meram Yeniyol Caddesi No:97 Meram KONYA, Postcode:42090
Country [1] 293521 0
Turkey
Primary sponsor type
Hospital
Name
Konya Training and Research Hospital
Address
Konya Training and Research Hospital, Haci Saban Mah. Meram Yeniyol Caddesi No:97 Meram KONYA, Postcode:42090
Country
Turkey
Secondary sponsor category [1] 292343 0
None
Name [1] 292343 0
Address [1] 292343 0
Country [1] 292343 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294962 0
Necmettin Erbakan University Meram School of Medicine
Ethics committee address [1] 294962 0
Necmettin Erbakan University Meram School of Medicine, Akyokus, Meram-Konya 42080
Ethics committee country [1] 294962 0
Turkey
Date submitted for ethics approval [1] 294962 0
14/02/2016
Approval date [1] 294962 0
19/02/2016
Ethics approval number [1] 294962 0
2016/464

Summary
Brief summary
Forty patients will be studied for this study. Routine monitoring (consisting of a pulse oximeter, 3-lead ECG and a non-invasive blood pressure cuff ) will applied. In addition to this monitoring two sensors (SomaSensors, Somanetics, Troy, MI) will be placed on each patient: One on the side of the peripheral nerve block and another at a similar site on the contralateral side. The sensor will be placed on the the ventral aspect of the mid-forearm. The sensors will connected to a two channel monitor (Invos 5100B monitor, Somanetics), which automatically recorded digital data approximately every 7 s for a maximum of 30 min.
A blind anesthesia nurse, will record both sides skin temperature at baseline, immediately after LIB and 1 min intervals for 30 min, starting immediately after performing LIB.A blind anesthesia nurse, will record both sides tissue oxygen saturation values from the monitor at baseline, immediately after LIB and 1 min intervals for 30 min, starting immediately after performing LIB.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 65638 0
Dr Mehmet SARGIN
Address 65638 0
Konya Training and Research Hospital, Anesthesiology and Reanimation Department, Haci Saban Mah. Meram Yeniyol Caddesi No:97 Post code: 42090 Meram KONYA
Country 65638 0
Turkey
Phone 65638 0
+905322662766
Fax 65638 0
Email 65638 0
mehmet21sargin@yahoo.com
Contact person for public queries
Name 65639 0
Dr Mehmet SARGIN
Address 65639 0
Konya Training and Research Hospital, Anesthesiology and Reanimation Department, Haci Saban Mah. Meram Yeniyol Caddesi No:97 Post code: 42090 Meram KONYA
Country 65639 0
Turkey
Phone 65639 0
+905322662766
Fax 65639 0
Email 65639 0
mehmet21sargin@yahoo.com
Contact person for scientific queries
Name 65640 0
Dr Mehmet SARGIN
Address 65640 0
Konya Training and Research Hospital, Anesthesiology and Reanimation Department, Haci Saban Mah. Meram Yeniyol Caddesi No:97 Post code: 42090 Meram KONYA
Country 65640 0
Turkey
Phone 65640 0
+905322662766
Fax 65640 0
Email 65640 0
mehmet21sargin@yahoo.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary