Efficacy Testing of Different Tourniquet Pressure Used for Postoperative Pain Reduction in Total Knee Arthroplasty

Thammasat University

Status: Unknown

Conditions: Osteoarthritis, Knee

Treatments: Device: Tourniquet: Systolic blood pressure + 150 mmHg; Device: Tourniquet: Systolic blood pressure + 75 mmHg; Device: Tourniquet: Systolic blood pressure + 100 mmHg

Study type: Interventional

Funder types: Other

Identifiers

NCT03931837

MTU-EC-OT-1-183/60

Details and patient eligibility

About

Tourniquet use during total knee replacement (TKR) improves visibility, significantly decreases intra-operative blood loss and reduce operative time. However, tourniquet use also has a negative effect on postoperative pain, postoperative range of motion(ROM), wound complication, deep vein thrombosis (DVT), pulmonary embolism (PE), thigh muscle strength, and functional recovery after TKR. Therefore, the investigators conducted a three-arm prospective, randomized, controlled trial study to compare the efficacy of different tourniquet pressure used between systolic blood pressure + 75 mmHg, systolic blood pressure + 100 mmHg, and systolic blood pressure + 150 mmHg.

Full description

Patients scheduled for unilateral primary TKA; 150 patients were randomly assigned to receive tourniquet pressure used of systolic blood pressure + 75 mmHg, systolic blood pressure + 100 mmHg, and systolic blood pressure + 150 mmHg.

All patients had spinal anesthesia, the same operative procedure, and postoperative pain protocol. A visual analogue scale (VAS) for pain were recorded 24, 48 hours, and 2 weeks postoperatively. Quality of bloodless visual field and calculated blood loss were evaluated perioperatively. Postoperative ROM, wound complication, deep vein thrombosis (DVT), pulmonary embolism (PE) were recorded at 2, 6, and 12 weeks. Furthermore, Knee Society Score (KSS) also recorded at 6 weeks, 3 and 6 months. The reviewers were blinded to the treatment group.

Enrollment: 150 estimated patients

Sex: All

Ages: 50 to 90 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adult patients with osteoarthritis in need of a TKR

Exclusion criteria

• Inflammatory arthritis
• Post-traumatic arthritis
• Body mass index > 30 Kg/m2
• A history of or current venous thromboembolic disease
• Any underlying disease of hemostasis, cirrhosis, chronic renal failure, patients on anticoagulants or strong antiplatelet drugs (e.g. warfarin, clopidogrel)
• Preoperative hemoglobin <10 g/dL or a platelet count < 140,000 /uL3
• Allergy to transamine

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 3 patient groups

Tourniquet: Systolic blood pressure + 75 mmHg

Experimental group

Description:

Before skin incision

Treatment:

Device: Tourniquet: Systolic blood pressure + 75 mmHg

Tourniquet: Systolic blood pressure + 100 mmHg

Experimental group

Description:

Before skin incision

Treatment:

Device: Tourniquet: Systolic blood pressure + 100 mmHg

Tourniquet: Systolic blood pressure + 150 mmHg

Experimental group

Description:

Before skin incision

Treatment:

Device: Tourniquet: Systolic blood pressure + 150 mmHg