Rotator Cuff Injuries, Rotator Cuff Tears, Subacromial Impingement, Subacromial Impingement Syndrome
Conditions
Brief 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
Detailed 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.
Interventions
DRUGEpinephrine
1 mL of 1:1000 mixed into irrigation bag.
DRUGTranexamic acid
1 g IV x 1 dose to be administered intraoperatively.
DRUGEpinephrine and Tranexamic Acid
1 mL of 1:1000 epinephrine mixed into irrigation bag, and 1 g tranexamic acid x 1 dose to be administered intraoperatively.
Sponsors
University of Manitoba
Panam Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Surgeons are blinded to group allocation as all IV bags will have labels appearing identical when turned away from the surgeon. Anesthetists are told not to reveal allocation to the surgeon as well. And patients will not be informed of their allocation.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Able to read and understand patient consent form and give informed consent * Rotator cuff pathology or impingement that have clinical indications for shoulder arthroscopy surgery (either rotator cuff repair or subacromial decompression
Exclusion criteria
* Have an active thromboembolic event * Allergies or hypersensitivies to TXA or any of the ingredients * Have a seizure disorder * On hormonal contraceptives * Pregnant * History of venous thromboembolism in the previous 12 months, or requiring lifelong anticoagulation related to previous VTE. VTE is defined as a cerebrovascular event (stroke, transient ischemic attack, deep vein thrombosis, and pulmonary embolism or with a history of hypercoagulable disorders (i.e. Factor V Lieden, antiphospholipid antibody) * Acquired disturbances of colour vision * Hematuria with renal cause
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visualization Quality Scale | Intra-operative | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Log Book for Pain and Medications | Day of surgery - post-operative day 14 | 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. |
Countries
Canada
Outcome results
None listed