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

Thammasat University150 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

150

Conditions

Osteoarthritis, Knee

Interventions

Tourniquet: Systolic blood pressure + 75 mmHgDEVICE

Spinal block without morphine. Medial parapatellar approach. Same posterior stabilized design and operated by a single surgeon. Drug: Peri-articular Transmine(15 mg/kg) combined with multimodal local anesthetic infiltration (0.5% bupivacaine 100 mg, morphine sulfate 5 mg, 0.1% epinephrine 0.6 mg, and ketorolac 30 mg) mixed NSS up to 75 mL. Procedure/Surgery: TXA combined with multimodal local anesthetic infiltration inject into peri-articular area (Anterior soft tissue 25 mL+Medial gutter area 25 mL+Lateral gutter area 25 mL) prior to capsular closure and tourniquet deflation

Tourniquet: Systolic blood pressure + 100 mmHgDEVICE

Tourniquet: Systolic blood pressure + 150 mmHgDEVICE

Eligibility

Sex: ALLMin age: 50 YearsMax age: 90 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Postoperative visual analogue scale for pain

(VAS, 0 = no pain, 10 = the worst imaginable pain)

Time frame: 48 hours after operation

Secondary Outcomes

Quality of bloodless visual field

(QBF, 0 = the worst quality, 10 = the best quality)

Time frame: Intraoperative evaluation

Changes from baseline hemoglobin concentrations

Time frame: 48 hours after operation

Postoperative range of motion

Record with long arm goniometer

Time frame: 2 weeks, 6 weeks and 12 weeks

Number of patient with local soft tissue complications

Time frame: 14 days after the operation

Number of patient with venous thromboembolism

Time frame: 14 days after the operation

Knee society score

Score from 0 to 100 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions

Time frame: 6 weeks, 12 weeks and 6 months