Effect of Tranexamic Acid (TXA) Administered Prior to Shoulder Arthroscopy on Postoperative Pain Medication Usage: A Randomized Controlled Trial
NCT06920264 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 165
Last updated 2025-04-09
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 consumption and a visual analog scale for pain (VAS) for the first 72 hours after surgery. Secondary outcomes will examine whether patients were satisfied overall with their postoperative pain control, whether the time to first opioid use is increased, and whether the surgeon perceives improved surgical visualization in patients who received TXA. We will also examine the number of times pump pressure was increased during the procedure to improve visualization.
Conditions
- This Study Will Evaluate Whether TXA Reduces Pain
Interventions
- DRUG
-
Tranexamic acid
A total of 150 participants will be enrolled and randomized 1:1 to receive either a standard dose of TXA (1000 mg) or an equivalent volume of placebo (normal saline, NS) at the time of surgery. .
- OTHER
-
placebo
saline
Sponsors & Collaborators
-
St. Louis Joint Replacement Institute
lead OTHER
Principal Investigators
-
Katherine Burns, MD · SSM Health Orthopedics
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- SINGLE_GROUP
Eligibility
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-07-01
- Primary Completion
- 2024-09-08
- Completion
- 2024-09-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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