Randomised controlled trial of tourniquet associated pain generated in lower limb after exsanguination by Esmarch bandage versus leg elevatio

Not Applicable

• Conditions: Pain generated by tourniquet; Surgery - Surgical techniques

• Registration Number: ACTRN12622000727741
• Lead Sponsor: Dr Alexander Mitrichev

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-05-20
• Last Update Posted: 30 May 2022

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

Healthy hospital staff members

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Area under the pain curve between 0 and 20 minute of tourniquet inflation <br>Calculated using VAS pain score<br>The minimum total area under pain curve will be 0, the maximum 200[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<br>]

Secondary Outcome Measures

Name	Time	Method
Pain score (VAS) at each time point [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<br>];Total pain experienced during recovery phase [Depends on when pain score will drop to 0<br>Expected within 10 minutes post deflation of tourniquet]