Comparison of the Efficacy of Irrigation With Epinephrine or Tranexamic Acid on Visual Clarity

Study Overview
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Brief Summary
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The primary aim of this report is to determine whether there is a difference between Epinephrine and Tranexamic acid in providing visual clarity during arthroscopic rotator cuff tear repair.

Official Title
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Comparison of the Efficacy of Irrigation With Epinephrine or Tranexamic Acid on Visual Clarity During Arthroscopic Rotator Cuff Repair: A Randomized Double-Blind Study

Conditions
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Rotator Cuff Tears

Intervention / Treatment
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* Drug: tranexamic acid
* Drug: Epinephrine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Age > 18 years American Society of Anesthesiologist Physical Status Classification System : 1-2 Undergoing a full arthroscopic double-row repair due to full-thickness cuff tear Being willing to participate the study Exclusion Criteria: • Age < 18 years American Society of Anesthesiologist Physical Status Classification System ≥3 Concomitant cardiac diseases Concomitant bleeding disorder or coagulopathy Diabetes mellitus Being pregnant Use of contraceptive pills A history of previous shoulder surgery Uncontrolled hypertension during the operation (>180/110 mm Hg) Unrepairable rotator cuff tears Being unwilling to participate the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TXA group<br>tranexamic acid added to irrigation solution | Drug: tranexamic acid<br>* Tranexamic acid is added to the irrigation fluid used in arthroscopic shoulder surgery.<br>* Other names: TRANSAMINE %5 5 ml 250 mg;|
| Experimental: EPN group<br>epinephrine added to irrigation solution | Drug: Epinephrine<br>* Epinephrine is added to the irrigation fluid used in arthroscopic shoulder surgery.<br>* Other names: ADRENALIN 0,5 mg/1 m;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analog scale | Visual analog scale will be rated by surgeon. While 0 is the worst score with no clear vision, 10 was noted as the best score for visual clarity. | through study completion, an average of 2 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total operating time | period in minutes from the time the arthroscope was inserted into the glenohumeral joint until the termination of the arthroscopic procedure | through study completion, an average of 2 year | 
| average mean arterial pressure | mean arterial pressure per operation. | through study completion, an average of 2 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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shoulder arthroscopy, irrigation, epinephrine, image quality, tranexamic acid, cuff tear repair, visual clarity