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Trial registered on ANZCTR


Registration number
ACTRN12621000475842
Ethics application status
Approved
Date submitted
13/02/2020
Date registered
21/04/2021
Date last updated
21/04/2021
Date data sharing statement initially provided
21/04/2021
Date results provided
21/04/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Effect of Infraclavicular Block on Tourniquet-Induced Ischaemia Reperfusion Injury
Scientific title
The Effect of Infraclavicular Block on Tourniquet-Induced Ischaemia Reperfusion Injury: A Prospective Randomized Study
Secondary ID [1] 300536 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
the periferal nerve block for tourniquet-induced ischaemia reperfusion injury 316246 0
Condition category
Condition code
Anaesthesiology 314534 314534 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study group comprised 60 number of males and females, aged between 18 and 65 y with ASA physical status I–III undergoing routine upper extremity surgery with a pneumatic tourniquet. The exclusion criteria were as follows: cardiac, metabolic, renal, or hepatic diseases; systemic rheumatological diseases; inflammatory, autoimmune, or peripheral vascular diseases; symptomatic diabetic microangiopathy (diabetic foot, diabetic retinopathy, etc.); known limb ischemia; deep vein thrombosis; or hemodynamic instability. Additional exclusion criteria were a history of cancer, a history of coronary artery disease within the previous year or extremity surgery within the previous 3 months, drug use that could impair the acid-base balance, steroid drug use, alcohol consumption and smoking.
The infraclavicular block (ICB) was applied using a USG multi-frequency linear probe (10–18 MHz) by a anesthesiologist. Lateral-sagittal technique was used when the block.. Then, 10 ml of 2% prilocaine and 10 ml of 0.5% bupivacaine (total dose = 20 ml) was given as intermittent negative aspiration as a local anesthetic mixture. U-shaped spread of local anesthesia around the three branches of the brachial plexus was confirmed by ultrasound. The tourniquet was continuously inflated to 250 mmHg on the operative arm and maintained to arrest blood flow until at the end of surgery.
Blood samples were drawn before the ICB and induction of GA, and these values were accepted as T1 values before tourniquet application. A pneumatic tourniquet routinely used in upper extremity procedures was inflated just before surgery to maintain the patient’s mean systolic blood pressure above 100 mmHg. Blood samples were drawn again 2 h after tourniquet opening, and these values were accepted as T2 values too. The blood samples were collected in tubes and stored at -20°C. Serum ischemia-modified albumin (IMA) levels were measured spectrophotometrically using a spectrophotometer and the albumin-cobalt binding method. The results were recorded in absorbance units (ABSUs). Colorimetric method kits were used for the measurement of serum total antioxidant status (TAS) and total oxidant status (TOS) levels. TAS and TOS levels were calculated (µmol H2O2 equivalent/L) using commercially available diagnostic kits. The TAS, TOS and IMA levels in the groups were also measured at different tourniquet times: 0–60 min and 61–120 min. All of the intervention is managed by anesthesiology.
Intervention code [1] 316840 0
Treatment: Other
Comparator / control treatment
In the general anesthesia (GA) group, the patients were anesthetized with 2 mg/kg-1 of propofol, 2 mg/kg-1 of fentanyl and 0.6 mg/kg-1 of rocuronium at the beginning of GA induction. The patients were intubated after 2 min of muscle relaxation. Anesthesia was maintained by administering 2–3% sevoflurane, 50% O2/air and 0.1 mg/kg/dk remifentanil infusion. At the end of the operation, the return of spontaneous breathing were provided with sugammadex (4 mg/kg-1), the patients were extubated.
Control group
Active

Outcomes
Primary outcome [1] 322856 0

Comparison of serum total antioxidant status (TAS) levels between two groups according to T1 and T2 times.
Timepoint [1] 322856 0
T1 values before tourniquet application, and T2 values 2 hour after tourniquet opening.
Primary outcome [2] 323191 0
Comparison of serum total oxidant status (TOS) levels between two groups according to T1 and T2 times.
Timepoint [2] 323191 0
T1 values before tourniquet application, and T2 values 2 hour after tourniquet opening.
Primary outcome [3] 323192 0
Comparison of serum ischemia-modified albumin (IMA) levels between two groups according to T1 and T2 times.
Timepoint [3] 323192 0
T1 values before tourniquet application, and T2 values 2 hour after tourniquet opening.
Secondary outcome [1] 380035 0
Comparison of serum TAS level between and within the groups according to 0-60 minutes the tourniquet times.
Timepoint [1] 380035 0
T1 values before tourniquet application, and T2 values 2 hour after tourniquet opening.
Secondary outcome [2] 381122 0
Comparison of serum TOS level between and within the groups according to the 61-120 minutes tourniquet times.
Timepoint [2] 381122 0
T1 values before tourniquet application, and T2 values 2 hour after tourniquet opening.
Secondary outcome [3] 387727 0
Comparison of serum IMA level between and within the groups according to 0-60 minutes the tourniquet times.
Timepoint [3] 387727 0
T1 values before tourniquet application, and T2 values 2 hour after tourniquet opening.

Eligibility
Key inclusion criteria
Sixty number of males and females, aged between 18 and 65 y with ASA physical status I–III undergoing routine upper extremity surgery with a pneumatic tourniquet..
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
cardiac, metabolic, renal, or hepatic diseases; systemic rheumatological diseases; inflammatory, autoimmune, or peripheral vascular diseases; symptomatic diabetic microangiopathy (diabetic foot, diabetic retinopathy, etc.); known limb ischemia; deep vein thrombosis; or hemodynamic instability. Additional exclusion criteria were a history of cancer, a history of coronary artery disease within the previous year or extremity surgery within the previous 3 months, drug use that could impair the acid-base balance, steroid drug use, alcohol consumption and smoking.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/09/2018
Date of last participant enrolment
Anticipated
Actual
1/09/2019
Date of last data collection
Anticipated
Actual
31/01/2020
Sample size
Target
60
Accrual to date
Final
80
Recruitment outside Australia
Country [1] 22350 0
Turkey
State/province [1] 22350 0
Konya

Funding & Sponsors
Funding source category [1] 304949 0
University
Name [1] 304949 0
Selcuk University, Medical Faculty
Country [1] 304949 0
Turkey
Primary sponsor type
University
Name
Selcuk University
Address
Department of Anaesthesiology, Selcuk University, Medical Faculty Campus 42250 Selcuklu/Konya, Turkey
Country
Turkey
Secondary sponsor category [1] 305307 0
None
Name [1] 305307 0
none
Address [1] 305307 0
Country [1] 305307 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305359 0
Selcuk University Meram School of Medicine
Ethics committee address [1] 305359 0
Ethics committee country [1] 305359 0
Turkey
Date submitted for ethics approval [1] 305359 0
15/02/2018
Approval date [1] 305359 0
07/03/2018
Ethics approval number [1] 305359 0
2018/81

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

Contacts
Principal investigator
Name 100110 0
A/Prof Faruk Cicekci
Address 100110 0
Department of Anaesthesiology, Selcuk University, Medical Faculty 42250 Konya, Turkey
Country 100110 0
Turkey
Phone 100110 0
+905057649235
Fax 100110 0
Email 100110 0
[email protected]
Contact person for public queries
Name 100111 0
Inci Kara
Address 100111 0
Department of Anaesthesiology, Selcuk University, Medical Faculty 42250 Konya, Turkey
Country 100111 0
Turkey
Phone 100111 0
+905054831819
Fax 100111 0
Email 100111 0
[email protected]
Contact person for scientific queries
Name 100112 0
Inci Kara
Address 100112 0
Department of Anaesthesiology, Selcuk University, Medical Faculty 42250 Konya, Turkey
Country 100112 0
Turkey
Phone 100112 0
+905054831819
Fax 100112 0
Email 100112 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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.