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

Phase 1

Completed

• Conditions: This Study Will Evaluate Whether TXA Reduces Pain
• Interventions: Drug: Tranexamic acid; Other: placebo

• Registration Number: NCT06920264
• Lead Sponsor: St. Louis Joint Replacement Institute

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 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.

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 Timeline

• Study Start: 2021-07-01
• Study First Submitted: 2021-10-06
• Primary Completion: 2024-09-08
• Study Completion: 2024-09-30
• Status Verified: 2025-04
• Study First Submitted QC: 2025-04-02
• Last Update Submitted: 2025-04-02
• Study First Posted: 2025-04-09
• Last Update Posted: 2025-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 165

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients who receive TXA will exhibit less pain	Tranexamic acid	as measured by opioid consumption and VAS for the first 72 hours after surgery
Patients who receive placebo will have higher pain	placebo	placebo

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Secondary outcome measures will be postoperative pain management satisfaction at 72 hours.	72 hours	include VAS, time to first opioid use, and patient satisfaction

Trial Locations

Locations (1)

SSM Health- DePaul; 🇺🇸 Bridgeton, Missouri, United States