Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000727741p
Ethics application status
Submitted, not yet approved
Date submitted
23/02/2022
Date registered
20/05/2022
Date last updated
20/05/2022
Date data sharing statement initially provided
20/05/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomised controlled trial of tourniquet associated pain generated in lower limb after exsanguination by Esmarch bandage versus leg elevation
Scientific title
Randomised controlled trial of tourniquet associated pain generated in lower limb after exsanguination by Esmarch bandage versus leg elevation in healthy hospital staff members
Secondary ID [1] 306510 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain generated by tourniquet 325379 0
Condition category
Condition code
Surgery 322762 322762 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Hospital pneumatic tourniquet will be used. Before inflating of tourniquet the lower limb will be exsanguinated with Esmarch bandage. Tourniquet device will be inflated to 300mm Hg which is standard pressure to perform lower limb surgeries. Skin under tourniquet will be
protected with softband. Pain score will be recorder every 2 minute for 20 minutes if participant can tolerate tourniquet. Tourniquet can be deflated earlier if
patient will report intolerable pain or would like to terminate study. Further assessment of pain profile will be conducted after deflation of tourniquet. Base
on the similar study we expect individuals to recover within 10 minutes. The research will be conducted in outpatient department. Low risk intervention does not require supervision.
Intervention code [1] 322936 0
Treatment: Surgery
Intervention code [2] 323486 0
Treatment: Devices
Comparator / control treatment
Other leg in the same person will be elevated up to 45 degrees for 1 minute then pneumatic hospital tourniquet will be applied by other researcher. Leg will remain in horizontal position after tourniquet is applied and inflated. Researcher will swap rooms with first researcher (see interventional group). Pain will be recorded every 2 minutes for 20 minutes. Tourniquet will be removed after 20 minutes but pain recording will be continue for 10 minutes. If pain will not completely disappeared the records will be continued. The research will be conducted in outpatient department.
Control group
Active

Outcomes
Primary outcome [1] 330559 0
Area under the pain curve between 0 and 20 minute of tourniquet inflation
Calculated using VAS pain score
The minimum total area under pain curve will be 0, the maximum 200
Timepoint [1] 330559 0
2 minute checks for 20 minutes post-tourniquet application. Then tourniquet will be released and pain checks will continue every 2 minutes for 10 minutes post-tourniquet removal or until pain is completely settled
Secondary outcome [1] 409246 0
Pain score (VAS) at each time point
Timepoint [1] 409246 0
Then tourniquet will be released and pain checks will continue every 2 minutes for 10 minutes post-tourniquet removal or until pain is completely settled
Secondary outcome [2] 409454 0
Total pain experienced during recovery phase
Timepoint [2] 409454 0
Depends on when pain score will drop to 0
Expected within 10 minutes post deflation of tourniquet

Eligibility
Key inclusion criteria
Healthy hospital staff members
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Nerve problems
Diabetes, multiple sclerosis, any disease affecting sensation or function
Loss of sensation/altered sensation in the foot, leg or thigh
Weakness of leg, ankle or foot
Compressive neuropathy of lower limbs
Any type of lower limb tendinitis
Hip, knee or ankle dislocation in past 12 months
Previous trauma to hip, knee ankle or foot resulted in deficit muscles power or sensation
Thoracic, lumbar or sacral spine osteoarthritis
Previous injury, trauma or surgery on thoracic, lumbar or sacral spine
Impingement of nerves or disc herniation in thoracic, lumbar or sacral spine
Circulation problems
Sickle cell disease, Raynaud’s Syndrome or any other disease that affects circulation
Clotting problems
Any history of blood clots including deep vein thrombosis (DVT) or pulmonary embolism (PE)
High blood pressure (controlled or uncontrolled), medication for high blood pressure
Previous heart attack or stroke
Surgery or fractures within the past 12 months anywhere on the lower limbs including hips, thighs, legs, an-kles or feet
Medications Warfarin, Aspirin, Clopidogrel, any other medication affecting blood clotting
Steroids, including inhalers
If participants takes medications: Warfarin
• Aspirin
• Clopidogrel
• Steroids, including inhalers
• Any medication that thins the blood
• Medication for high blood pressure

Study design
Purpose of the study
Prevention
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
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/06/2022
Actual
Date of last participant enrolment
Anticipated
4/07/2022
Actual
Date of last data collection
Anticipated
4/07/2022
Actual
Sample size
Target
32
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 21803 0
Townsville University Hospital - Douglas
Recruitment hospital [2] 21804 0
Cairns Base Hospital - Cairns
Recruitment postcode(s) [1] 36861 0
4814 - Douglas
Recruitment postcode(s) [2] 36862 0
4870 - Cairns

Funding & Sponsors
Funding source category [1] 310855 0
Self funded/Unfunded
Name [1] 310855 0
unfunded
Country [1] 310855 0
Primary sponsor type
Individual
Name
Dr Alexander Mitrichev
Address
Townsville University Hospital, 100 Angus Smith Drive, Douglas QLD 4814
Country
Australia
Secondary sponsor category [1] 312882 0
None
Name [1] 312882 0
Address [1] 312882 0
Country [1] 312882 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 310418 0
Townsville Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 310418 0
Townsville University Hospital, 100 Angus Smith Drive, Douglas QLD 4814
Ethics committee country [1] 310418 0
Australia
Date submitted for ethics approval [1] 310418 0
17/02/2022
Approval date [1] 310418 0
Ethics approval number [1] 310418 0

Summary
Brief summary
We hypothesised that pain generated by tourniquet after exsanguination of lower limb with Esmarch is significantly lower comparing with pain from elevated lower limb for one minute and applied same type of tourniquet. We intend to record pain score generated by these two methods of exsanguination every 2 minutes for 20 minutes of tourniquet type and for 10 minutes after tourniquet is released. Pain curve will be the primary parameters where the pain in each point of time and time of full recovery will be the second paremetres. We will use one leg of participant for Esmarch group and the second leg for elevation group. Sides of interventions will be randomly chosen.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 117594 0
Dr Alexander Mitrichev
Address 117594 0
Queensland Health, Townsville University Hospital, 100 Angus Smith Drive, Douglas, Queensland, 4814
Country 117594 0
Australia
Phone 117594 0
+61420811881
Fax 117594 0
Email 117594 0
Alexander.mitrichev@gmail.com
Contact person for public queries
Name 117595 0
Dr Alexander Mitrichev
Address 117595 0
Queensland Health, Townsville University Hospital, 100 Angus Smith Drive, Douglas, Queensland, 4814
Alexander Mitrichev
Country 117595 0
Australia
Phone 117595 0
+61420811881
Fax 117595 0
Email 117595 0
Alexander.mitrichev@gmail.com
Contact person for scientific queries
Name 117596 0
Dr Alexander Mitrichev
Address 117596 0
Queensland Health, Townsville University Hospital, 100 Angus Smith Drive, Douglas, Queensland, 4814
Alexander Mitrichev
Country 117596 0
Australia
Phone 117596 0
+61420811881
Fax 117596 0
Email 117596 0
Alexander.mitrichev@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?




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.