Effect of Tranexamic Acid (TXA) Administered Prior to Shoulder Arthroscopy on Postoperative Pain Medication Usage: A Randomized Controlled Trial

April 2, 2025 updated by: St. Louis Joint Replacement Institute
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 rotator cuff repair with or without concomitant procedures. Patients undergoing shoulder arthroscopy for any other reason will be excluded, including isolated labral repair, isolated distal clavicle excision, frozen shoulder, isolated decompression or debridement. Medical exclusion criteria will include allergy or known sensitivity to TXA, known renal disease with previously documented creatinine >1.5, history of coagulopathy, DVT or PE requiring ongoing anticoagulation, baseline long-acting opioid use, a documented history of COVID-19 infection within 90 days of surgery.

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. The primary outcome measure will be postoperative opioid consumption as measured by pill count for 72 hours, calculated as morphine equivalent dose (MED). Secondary outcome measures will include subjective measurement of pain as rated on the VAS, time to first opioid use, and patient satisfaction with postoperative pain management at 72 hours. Operative time, surgeon rating of overall visibility during the procedure, and number of times pump pressure was increased during the procedure will also be compared between groups.

Study Type

Interventional

Enrollment (Actual)

165

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Bridgeton, Missouri, United States, 63044
        • SSM Health- DePaul

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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 Criteria:

  • Surgical exclusion criteria:

    1. Revision procedures
    2. Irreparable tears including planned allograft augmentation and superior capsular reconstruction (SCR) procedures
    3. Goutallier staging for fatty infiltration of 3 or higher
    4. Substantial underlying arthritis (Samuelson and Prieto grade 2 or higher).

Medical exclusion criteria:

  1. Allergy, known sensitivity to TXA.
  2. Renal insufficiency as defined by serum creatinine >1.5 prior to surgery.
  3. History of coagulopathy, DVT or PE requiring ongoing anticoagulation.
  4. Baseline opioid use of long-acting medications including Fentanyl patches, Oxycontin CR, or MS Contin.
  5. Documented history of COVID-19 infection within 90 days of surgery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Patients who receive TXA will exhibit less pain
as measured by opioid consumption and VAS for the first 72 hours after surgery
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. .
Placebo Comparator: Patients who receive placebo will have higher pain
placebo
Other: placebo
saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
primary outcome measure will be postoperative opioid consumption as measured by pill count for 72 hours, calculated as morphine equivalent dose (MED).
Time Frame: 72 hours
72 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary outcome measures will be postoperative pain management satisfaction at 72 hours.
Time Frame: 72 hours
include VAS, time to first opioid use, and patient satisfaction
72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Louis Joint Replacement Institute

Investigators

  • Principal Investigator: Katherine Burns, MD, SSM Health Orthopedics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2021

Primary Completion (Actual)

September 8, 2024

Study Completion (Actual)

September 30, 2024

Study Registration Dates

First Submitted

October 6, 2021

First Submitted That Met QC Criteria

April 2, 2025

First Posted (Actual)

April 9, 2025

Study Record Updates

Last Update Posted (Actual)

April 9, 2025

Last Update Submitted That Met QC Criteria

April 2, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-12-1991

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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