Tranexamic Acid to Improve Arthroscopic Visualization in Shoulder Surgery

Status Completed

Clinical Trial Summary

The purpose of this study is to determine if intravenous TXA is a safe alternative to epinephrine in improving arthroscopic shoulder visualization. Primary Objectives 1. Determine that patients given intravenous tranexamic acid improves surgeon-rated visualization compared to placebo. 2. Determine that intravenous tranexamic acid is a safe alternative to epinephrine mixed irrigation fluid to improve arthroscopic shoulder visualization

Clinical Trial Description

In the last twenty years, the use of arthroscopy to surgically manage shoulder pathologies has expanded in its indications. The interplay between increased indications, surgeon experience, and improvements in equipment have all propelled arthroscopic shoulder surgery to preferred treatment in managing instability, rotator cuff, and impingement pathology. Obtaining adequate visual clarity is paramount to performing the procedures safely, efficiently, and effectively. A variety of methods have been employed to improve visualization. This includes tighter control of blood pressure, regional anesthetic, pressure controlled irrigation system, sealed cannulas, electrocautery devices, and injecting epinephrine into irrigation fluid. The use of epinephrine in irrigation fluid has been studied in literature. The results of a few randomized controlled trials demonstrate that the vasoconstrictive properties of epinephrine decrease blood flow and consequently, improves surgeon visualization. However, there has been reports of ventricular tachycardia, lethal arrhythmias, and epinephrine induced pulmonary edema in literature that suggests that the addition of epinephrine in irrigation fluid may have caused these adverse events. Therefore, it is important to examine other alternatives, such as TXA, that can decrease bleeding and improve visualization without potential detrimental effects. This trial will be conducted in compliance with the protocol, GCP, and the applicable regulatory requirements. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04594408
Study type	Interventional
Source	Panam Clinic
Contact
Status	Completed
Phase	Phase 4
Start date	September 1, 2020
Completion date	January 1, 2024

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04974242` - Physiotherapy for Patients Awaiting Rotator Cuff Repair	N/A
Recruiting	`NCT06055478` - Effect of Suprascapular Nerve Block and Axillary Nerve Block After Arthroscopic Rotator Cuff Repair	N/A
Completed	`NCT04552925` - Exercises With Electromyographic Biofeedback in Conservative Treatment of Massive Rotator Cuff Tears	N/A
Not yet recruiting	`NCT06032416` - DenCT Shoulder Bone Quality Evaluation	N/A
Not yet recruiting	`NCT04047745` - Post-operative Exparel Study Following Rotator Cuff Repair	N/A
Completed	`NCT01029574` - Platelet Rich Plasma on Rotator Cuff Repair	Phase 3
Not yet recruiting	`NCT05817578` - Profiling the RCRSP Patient: a Pain Phenotype Classification Algorithm
Not yet recruiting	`NCT05670080` - Does MI Have a Therapeutic Role in Arthroscopic Rotator Cuff Repair?	N/A
Suspended	`NCT04421417` - The Effect of Microfracture Procedure on Rotator Cuff Tendon Healing	N/A
Recruiting	`NCT06156423` - Investigation of the Effect of Motor Control Exercises in Patients Undergoing Rotator Cuff Surgery	N/A
Completed	`NCT06145815` - Machine Learning Predictive Model for Rotator Cuff Repair Failure
Not yet recruiting	`NCT05009498` - Vitamin D3 Supplementation for Vitamin D Deficiency in Rotator Cuff Repair Surgery	N/A
Terminated	`NCT04855968` - The Effect of Mindfulness/Meditation on Post-operative Pain and Opioid Consumption	N/A
Not yet recruiting	`NCT04538001` - Safety and Efficacy of Rotator Cuff Function Restoration Balloon in Irreparable Rotator Cuff Tear	N/A
Completed	`NCT04710966` - Comparison Between Arthroscopic Debridement and Repair for Partial-thickness Rotator Cuff Tears	N/A
Recruiting	`NCT06192459` - Effect of the Muscle Strength and Range of Motion Training for Post-platelet Rich Plasma Injection in People With Rotator Cuff Partial Tear	N/A
Recruiting	`NCT05925881` - Lower Trapezius Transfer vs Bridging Reconstruction	N/A
Recruiting	`NCT05988541` - Rotator Cuff Integrity and Clinical Outcomes 5 Years After Repair.	N/A
Not yet recruiting	`NCT04584476` - Superior Capsular Reconstruction Versus. Partial Repair for Irreparable Rotator Cuff Tears	N/A
Not yet recruiting	`NCT04587037` - A Clinical Study Comparing Superior Capsule Reconstruction Using Different Graft for Irreparable Rotator Cuff Tear	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.