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

NCT06920264 | Completed Phase 1 FDA Drug

• 1 other identifier: 20-12-1991
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

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.

Conditions

This Study Will Evaluate Whether TXA Reduces Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Secondary outcome measures will be postoperative pain management satisfaction at 72 hours.

  72 hours

Study Arms (2)

Patients who receive TXA will exhibit less pain

ACTIVE COMPARATOR

as measured by opioid consumption and VAS for the first 72 hours after surgery

Drug: Tranexamic acid

Patients who receive placebo will have higher pain

PLACEBO COMPARATOR

placebo

Other: placebo

Interventions

Tranexamic acid DRUG

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. .

Patients who receive TXA will exhibit less pain

placebo OTHER

saline

Patients who receive placebo will have higher pain

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• St. Louis Joint Replacement Institute: lead

Study Sites (1)

SSM Health- DePaul

Bridgeton, Missouri, 63044, United States

Location

Related Publications (6)

• Lin ZX, Woolf SK. Safety, Efficacy, and Cost-effectiveness of Tranexamic Acid in Orthopedic Surgery. Orthopedics. 2016 Mar-Apr;39(2):119-30. doi: 10.3928/01477447-20160301-05. Epub 2016 Mar 4.

  PMID: 26942474 BACKGROUND

• Pauzenberger L, Domej MA, Heuberer PR, Hexel M, Grieb A, Laky B, Blasl J, Anderl W. The effect of intravenous tranexamic acid on blood loss and early post-operative pain in total shoulder arthroplasty. Bone Joint J. 2017 Aug;99-B(8):1073-1079. doi: 10.1302/0301-620X.99B8.BJJ-2016-1205.R1.

  PMID: 28768785 BACKGROUND

• Kirsch JM, Bedi A, Horner N, Wiater JM, Pauzenberger L, Koueiter DM, Miller BS, Bhandari M, Khan M. Tranexamic Acid in Shoulder Arthroplasty: A Systematic Review and Meta-Analysis. JBJS Rev. 2017 Sep;5(9):e3. doi: 10.2106/JBJS.RVW.17.00021.

  PMID: 28902659 BACKGROUND

• Hurley ET, Lim Fat D, Pauzenberger L, Mullett H. Tranexamic acid for the Latarjet procedure: a randomized controlled trial. J Shoulder Elbow Surg. 2020 May;29(5):882-885. doi: 10.1016/j.jse.2020.01.066.

  PMID: 32305106 BACKGROUND

• Liu YF, Hong CK, Hsu KL, Kuan FC, Chen Y, Yeh ML, Su WR. Intravenous Administration of Tranexamic Acid Significantly Improved Clarity of the Visual Field in Arthroscopic Shoulder Surgery. A Prospective, Double-Blind, and Randomized Controlled Trial. Arthroscopy. 2020 Mar;36(3):640-647. doi: 10.1016/j.arthro.2019.10.020. Epub 2019 Dec 20.

  PMID: 31870749 BACKGROUND

• Karaaslan F, Karaoglu S, Yurdakul E. Reducing Intra-articular Hemarthrosis After Arthroscopic Anterior Cruciate Ligament Reconstruction by the Administration of Intravenous Tranexamic Acid: A Prospective, Randomized Controlled Trial. Am J Sports Med. 2015 Nov;43(11):2720-6. doi: 10.1177/0363546515599629. Epub 2015 Sep 2.

  PMID: 26337246 BACKGROUND

MeSH Terms

Interventions

Tranexamic Acid

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Katherine Burns, MD

  SSM Health Orthopedics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2021
• First Posted: April 9, 2025
• Study Start: July 1, 2021
• Primary Completion: September 8, 2024
• Study Completion: September 30, 2024
• Last Updated: April 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)