Osteoarthritis,Knee
Conditions
Keywords
Tranexamic acid, Peri-articular injection, Intraarticular injection, Total knee arthroplasty, Blood loss
Brief summary
Post-operative bleeding in total knee arthroplasty (TKA) can result in hypovolemic shock and unnecessity for allogenic blood transfusions. Intravenous and topical tranexamic acid (TXA) have been well established in reducing blood loss postoperatively. However, there are lack of data on peri-articular TXA injection during TKA. Therefore, the investigators conducted a three-arm prospective, randomized, controlled trial to compare the effectiveness of bleeding reduction of peri-articular TXA injections, intraarticular TXA injections and control group.
Detailed description
Patients scheduled for unilateral primary TKA; 108 patients were randomly assigned to receive peri-articular TXA, intraarticular TXA and control group. 36 patients received either: (I) 15 mg/kg peri-articular TXA combined with multimodal local anesthetic infiltration (bupivacaine, morphine, ketorolac and epinephrine) into the anterior soft tissue, medial gutter area, lateral gutter area prior to capsular closure and tourniquet deflation (group 1). (II) 2 g of intraarticular TXA after complete capsular closure just before tourniquet deflation (group 2). (III) Don't receive any route of TXA in control group (group 3). Hemoglobin (Hb) concentrations were measured at 24 and 48 hour, and the number of blood transfusions and knee circumference measurements were recorded. Serum TXA was recorded at 2 and 24 hours after operation. The reviewers were blinded to treatment group.
Interventions
DRUGPeri-articular TXA (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
DRUGIntraarticular TXA 2 g (40 mL)
inject separate from 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)
PROCEDURETXA 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
PROCEDURETXA 40 mL inject into intraaricular knee capsule
after multimodal local anesthetic infiltration (Anterior soft tissue 25 mL+Medial gutter area 25 mL+Lateral gutter area 25 mL) prior to tourniquet deflation
Sponsors
Boontanapibul, Krit, M.D.
Thammasat University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Adult patients with osteoarthritis in need of a TKA
Exclusion criteria
* Inflammatory arthritis * Post-traumatic arthritis * A history of or current venous thromboembolic disease * Any underlying disease of haemostasis, 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 TXA
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes from baseline hemoglobin concentrations | 48 hours after the operation |
| Unit of blood transfusion | 48 hours after the operation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Local soft tissue complications | 14 days after the operation | — |
| Skin necrosis | 24 and 48 hours after the operation | — |
| Tranexamic acid level in blood | 2 and 24 hours after the operation | — |
| Visual Analogue Scales | 24 and 48 hours after the operation | (VAS, 0 = no pain, 10 = the worst imaginable pain) |
| Knee flexion angle | 24 and 48 hours after the operation | — |
| Number of patient with venous thromboembolism | 14 days after the operation | — |
| Knee diameter for swelling | 24 and 48 hours after the operation | — |
Countries
Thailand
Contacts
Primary ContactPiya Pinsornsak, MD
Outcome results
None listed