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

Not Applicable

• Conditions: Osteoarthritis, Knee

• Registration Number: NCT03931837
• Lead Sponsor: Thammasat University

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.

Study Timeline

• Status Verified: 2019-04
• Study First Submitted: 2019-04-16
• Study First Submitted QC: 2019-04-25
• Study First Posted: 2019-04-30
• Study Start: 2019-05-01
• Last Update Submitted: 2019-05-03
• Last Update Posted: 2019-05-07
• Primary Completion: 2020-04-30
• Study Completion: 2020-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Postoperative visual analogue scale for pain	48 hours after operation	(VAS, 0 = no pain, 10 = the worst imaginable pain)

Secondary Outcome Measures

Name	Time	Method
Quality of bloodless visual field	Intraoperative evaluation	(QBF, 0 = the worst quality, 10 = the best quality)
Postoperative range of motion	2 weeks, 6 weeks and 12 weeks	Record with long arm goniometer
Number of patient with venous thromboembolism	14 days after the operation
Changes from baseline hemoglobin concentrations	48 hours after operation
Number of patient with local soft tissue complications	14 days after the operation
Knee society score	6 weeks, 12 weeks and 6 months	Score from 0 to 100 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions

Trial Locations

Locations (1)

Thammasat university hospital; 🇹🇭 Pathumthani, Klongluang, Thailand