Skip to content

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

Randomised controlled trial of tourniquet associated pain generated in lower limb after exsanguination by Esmarch bandage versus leg elevation in healthy hospital staff members

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622000727741
Enrollment
52
Registered
2022-05-20
Start date
2023-05-02
Completion date
2023-05-08
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 stud

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.

Sponsors

Dr Alexander Mitrichev
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Primary purpose
Prevention

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026