Status:
COMPLETED
Effect of Tranexamic Acid (TXA) Administered Prior to Shoulder Arthroscopy on Postoperative Pain Medication Usage: A Randomized Controlled Trial
Lead Sponsor:
St. Louis Joint Replacement Institute
Conditions:
This Study Will Evaluate Whether TXA Reduces Pain
Eligibility:
All Genders
Phase:
PHASE1
Brief Summary
To our knowledge, no studies examining the use of TXA after shoulder arthroscopy in an outpatient setting have been published. This study will evaluate whether TXA reduces pain as measured by opioid c...
Detailed Description
We will conduct a double-blind, placebo-controlled randomized clinical trial (RCT) to assess if there is benefit to use of TXA in shoulder arthroscopy. The study will include patients scheduled for ro...
Eligibility Criteria
Inclusion
- Patients scheduled to have shoulder arthroscopy with the PI (KAB)
- shoulder arthroscopy for partial or full thickness rotator cuff tear confirmed on MRI or CT arthrogram preoperatively.
- willing to sign consent to participation and randomization.
Exclusion
- Surgical exclusion criteria:
- Revision procedures
- Irreparable tears including planned allograft augmentation and superior capsular reconstruction (SCR) procedures
- Goutallier staging for fatty infiltration of 3 or higher
- Substantial underlying arthritis (Samuelson and Prieto grade 2 or higher).
- Medical exclusion criteria:
- Allergy, known sensitivity to TXA.
- Renal insufficiency as defined by serum creatinine \>1.5 prior to surgery.
- History of coagulopathy, DVT or PE requiring ongoing anticoagulation.
- Baseline opioid use of long-acting medications including Fentanyl patches, Oxycontin CR, or MS Contin.
- Documented history of COVID-19 infection within 90 days of surgery.
Key Trial Info
Start Date :
July 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2024
Estimated Enrollment :
165 Patients enrolled
Trial Details
Trial ID
NCT06920264
Start Date
July 1 2021
End Date
September 30 2024
Last Update
April 9 2025
Active Locations (1)
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1
SSM Health- DePaul
Bridgeton, Missouri, United States, 63044