The primary purpose of this study is to evaluate postoperative pain. Secondary outcomes evaluated in this study will include range of motion (ROM), opioid consumption, and ambulation. Each outcome measure will be evaluated, oral tranexamic acid (TXA) in the experiment arm and placebo in the control arm, after total knee arthroplasty (TKA) at postoperative days 0-3, and weeks 1, 2, 6, and 12.
Randomized controlled trial with 1:1 allocation, selected through computer-based randomization. This study will review prospectively collected data, including patient demographic information, surgeon, use of oral tranexamic acid (TXA) or placebo regimen, and postoperative outcomes up to 3 months after surgery. Collaboration with Saint Francis' pharmacy team will be performed to ensure appropriate blinded administering of the oral TXA and placebo medication. This will be a double blinded study, with both patient and surgeon blinded to study group. 6.0 TXA dosing protocol TXA day of surgery \[All patients\] * Administer 1-gram IV TXA intraoperatively at the start of the case (hold for history of stent within 1 year of surgery) o AND * Administer 1-gram IV TXA postoperatively before leaving PACU (hold for history of stent within 1 year of surgery) o OR * Exception: Administer 2 grams TXA in 50cc normal saline topically during the case for patients with a history of stent placed within one year of surgery. TXA postoperative day (POD) 1-3 \[Experimental group\] * Administer 1.95 grams oral (3- 650 mg tablets) TXA each morning for three days following surgery. * Patients discharged home before POD 3 will be sent home with remaining oral TXA doses. Placebo POD 1-3 \[Control group\] * Administer oral placebo (3 tablets) each morning for three days following surgery. * Patients discharged home before POD 3 will be sent home with remaining oral placebo doses.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
80
1.95 grams oral
Trinity Health Of New England/CT Joint Replacement Institute
Hartford, Connecticut, United States
RECRUITINGVisual Analogue Scale (VAS) Pain scores
Patient reported pain score from 0 to 10 where 0 is no pain and 10 is the most pain. Higher scores are a worse outcome.
Time frame: postoperative day (POD) 0, 1, 2, 3 (+/- 0 days) and weeks 1 (+/- 0 days), 2 (+/- 2 days), 6 and 12 (+/- 7 days).
Range of Motion
Clinical measurement of passive, pain-free range of motion of knee in degrees from 0 to 180 from maximum extension to maximum flexion
Time frame: at 2, 6 and 12 week follow up visits
Opioid consumption
Subjects will keep a log recording opioid consumption. Research staff will ask subjects to report opioids during postoperative telephone calls.
Time frame: POD 1, 2, 3 (+/- 0 days) and weeks 1 (+/- 0 days), 2 (+/- 2 days), 6 and 12 (+/- 7 days)
Ambulation Status
Surgeon or physical therapist will record if patient is using a walker, cane or no assistive devices.
Time frame: at 2, 6 and 12 week follow up visits
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