A Phase 4 interventional study of Epinephrine and Tranexamic acid in Rotator Cuff Injuries, Rotator Cuff Tears and Subacromial Impingement, sponsored by Panam Clinic. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-02.
Sponsored by Panam Clinic · Phase 4, Interventional, and Treatment
The purpose of this study is to determine if intravenous TXA is a safe alternative to epinephrine in improving arthroscopic shoulder visualization.
Primary Objectives
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.
304 studies on the registry are indexed under Shoulder Impingement Syndrome; 55 are open to participants now.
This study's enrollment of 128 is above the median of 54 across 261 interventional studies indexed under Shoulder Impingement Syndrome.
Browse Shoulder Impingement Syndrome studies →Panam Clinic is the lead sponsor of 16 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
No intervention given.
Epinephrine intervention used.
Drug: Epinephrine
Tranexamic acid intervention used.
Drug: Tranexamic acid
Epinephrine and tranexamic acid intervention used.
Drug: Epinephrine and Tranexamic Acid
1 mL of 1:1000 mixed into irrigation bag.
Also known as: Epi
1 g IV x 1 dose to be administered intraoperatively.
Also known as: TXA
1 mL of 1:1000 epinephrine mixed into irrigation bag, and 1 g tranexamic acid x 1 dose to be administered intraoperatively.
Also known as: TXA, Epi
Visualization Quality Scale
Surgeons are asked every 15 minutes to report on the quality of visualization based on a 4-point scale. Minimum value is 0, maximum value is 3 with the higher value reflecting improved visualization
Time frame: Intra-operative
Patient Log Book for Pain and Medications
Patients are sent home from surgery with a log book to track the level of pain they are experiencing as well as the medications that they take.
Time frame: Day of surgery - post-operative day 14
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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