Clinical trial NCT03931837: Efficacy Testing of Different Tourniquet Pressure Used for Postoperative Pain Reduction in Total Knee Arthroplasty
Official title: Efficacy Testing of Different Tourniquet Pressure Used for Postoperative Pain Reduction in Total Knee Arthroplasty: A Prospective, Randomized Controlled Trials
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: Tourniquet
Total knee arthroplasty
Postoperative pain
Range of motion
Wound complication
Lead sponsor: Thammasat University
Sponsor class: OTHER
Collaborators: name: Boontanapibul, Krit, M.D.
First posted: 2019-04-30
Enrollment: 150
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative visual analogue scale for pain
timeFrame: 48 hours after operation
Secondary outcomes:
measure: Quality of bloodless visual field
timeFrame: Intraoperative evaluation
measure: Changes from baseline hemoglobin concentrations
timeFrame: 48 hours after operation
measure: Postoperative range of motion
timeFrame: 2 weeks, 6 weeks and 12 weeks
measure: Number of patient with local soft tissue complications
timeFrame: 14 days after the operation
measure: Number of patient with venous thromboembolism
timeFrame: 14 days after the operation
measure: Knee society score
timeFrame: 6 weeks, 12 weeks and 6 months
Other outcomes:
Locations:
city: Pathumthani
country: Thailand
facility: Thammasat university hospital
state: Klongluang
Study officials:
affiliation: Thammasat University Hospital
name: Piya Pinsornsak
role: PRINCIPAL_INVESTIGATOR
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