Degenerative lumbar spine disease Lumbar spinal stenosis Spondylolisthesis Postoperative blood loss Spinal fusion surgery Tranexamic acid, spinal fusion, posterior lumbar fusion, blood loss, antifibrinolytic agents, lumbar spinal stenosis, spondylolisthesis, randomized controlled trial
Conditions
Interventions
Participants in this group will receive tranexamic acid 15 mg/kg, with a maximum dose of 1.5 g, diluted in 50 mL of normal saline. The solution will be infiltrated directly into the paraspinal muscles
Experimental Procedure/Surgery,Active Comparator Procedure/Surgery
Tranexamic acid (local infiltration),Tranexamic acid (intravenous injection)
Sponsors
Panlop Tirawanish
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. Adults aged 18 years and older who are diagnosed with degenerative lumbar spine disease 2. Patients scheduled for posterior lumbar fusion involving one or two spinal levels 3. Patients presenting with persistent severe radicular pain not responding to conservative treatment for at least 3 months 4. Patients with progressive neurological deficits such as numbness or muscle weakness consistent with radiographic findings 5. Radiological confirmation of lumbar degenerative disease by magnetic resonance imaging or computed tomography 6. Patients who are able and willing to provide written informed consent
Exclusion criteria
Exclusion criteria: Patients with lumbar degenerative disease involving more than two spinal levels Patients with previous lumbar spine surgery Patients with spinal tumors or active spinal infections Patients with lumbar fractures due to trauma Patients with rheumatoid arthritis or metabolic bone disease affecting the lumbar spine Patients with history of thromboembolic events including deep vein thrombosis, pulmonary embolism, myocardial infarction, or stroke Patients with renal failure or creatinine clearance less than 30 milliliters per minute Patients with known allergy or hypersensitivity to tranexamic acid
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total postoperative blood loss Within 48 hours after surgery Calculated total blood loss using the Mercuriali and Inghilleri method based on hematocrit values and patient blood volume. | — |
Secondary
| Measure | Time frame |
|---|---|
| Intraoperative blood loss At the end of surgery Measured in milliliters from suction volume and soaked gauze weight,Incidence of thromboembolic events Within 6 weeks after surgery Clinical diagnosis confirmed by Doppler ultrasound or computed tomography pulmonary angiography,Incidence of wound related complications At 2 weeks and 6 weeks after surgery Clinical assessment of wound for hematoma infection or dehiscence by physical examination,Length of hospital stay At the time of discharge after surgery Number of days from admission to hospital discharge | — |
Countries
Thailand
Contacts
Public ContactPanlop Tirawanish
Mahidol University Faculty of Medicine Siriraj Hospital
Outcome results
None listed