Effects of oral tranexamic acid after knee surgery

Effects of Oral Tranexamic Acid Following Total Knee Arthroplasty on Postoperative Pain and Range of Motion: A Randomized Control Trial

This study is testing if taking oral tranexamic acid after knee surgery can help reduce pain and improve recovery for patients.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years to 89 Years
• Sex: All
• Sponsor: Trinity Health Of New England (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Hartford, Connecticut)
• Trial ID: NCT06479161 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the impact of oral tranexamic acid (TXA) on postoperative pain following total knee arthroplasty (TKA). It is a randomized controlled trial with a 1:1 allocation, where participants receive either TXA or a placebo for three days after surgery. The study will assess various outcomes, including pain levels, range of motion, opioid consumption, and ambulation, over a period of three months. Both patients and surgeons will be blinded to the treatment allocation to ensure unbiased results.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-89 undergoing primary total knee arthroplasty due to knee osteoarthritis.

Not a fit: Patients with a history of stent placement within one year, actively treated cancer, or chronic opioid use may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved pain management and reduced opioid consumption for patients undergoing knee surgery.

How similar studies have performed: Other studies have shown promising results with tranexamic acid in reducing postoperative bleeding, but this specific approach for pain management is less established.

Eligibility criteria

Inclusion Criteria:

* \- All patients undergoing either manual or robotic primary total knee arthroplasty (TKA)
* Performed by participating Connecticut Joint Replacement Institute (CJRI) surgeons (Dr. Matthew Grosso, Dr. Robert McAllister, Dr. Chad Daniel, Dr. Eric Silverstein, Dr. Alex Dukas, Dr. Michael Joyce, Dr. Brett Wasserlauf).
* Male and female patient age 18-89
* Primary diagnosis of knee osteoarthritis

Exclusion Criteria:

* Revision TKA
* No exclusion based on gender
* Patients \<18 and \>89 years old
* Exclusion for IV oral tranexamic acid (TXA):

  * TXA allergy - there are NO absolute contraindications for TXA use.
  * History of stent placed within one year of surgery - patient will receive topical TXA as an alternative.
* Exclusion for oral TXA:

  o Actively treated cancer or deep vein thrombosis (DVT)
* Chronic opioid use (opioid use within the 4 weeks prior to surgery)
* Allergies to nonsteroidal Anti-inflammatory drugs (NSAIDs) and acetaminophen
* Patients with clinically significant drug interactions
* Pre-existing neuropathy
* Current or previous venous thrombosis (DVT or venous stasis disease)
* Immuno-compromised secondary to medical condition
* Immune-suppressive medications, chemotherapy
* Pregnancy, breast feeding
* History of pain catastrophizing. Major depressive disorder
* History of suspected or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
* Currently on a neuroleptic agent \[e.g., gabapentin, pregabalin (Lyrica), duloxetine (Cymbalta) etc.\].
* Non-English speaking and reading patient populations
* Any clinically significant event or condition uncovered during the surgery (e.g., excessive bleeding, acute sepsis) that, in the opinion of the investigator, renders the subject medically unstable or complicates the subject's post-operative course.

Where this trial is running

Hartford, Connecticut

• Trinity Health Of New England/CT Joint Replacement Institute — Hartford, Connecticut, United States (Recruiting)

Study contacts

• Study coordinator: Gina Panek, BS

Conditions Postoperative Pain