Back to resultsComparison of the Efficacy of Irrigation With Epinephrine or Tranexamic Acid on Visual Clarity
Primary Purpose
Rotator Cuff Tears
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
tranexamic acid
Epinephrine
Sponsored by
About this trial
This is an interventional basic science trial for Rotator Cuff Tears focused on measuring shoulder arthroscopy, irrigation, epinephrine, image quality, tranexamic acid, cuff tear repair, visual clarity
Eligibility Criteria
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
Sites / Locations
- Haseki Training and Research Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
TXA group
EPN group
Arm Description
tranexamic acid added to irrigation solution
epinephrine added to irrigation solution
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
total operating time
period in minutes from the time the arthroscope was inserted into the glenohumeral joint until the termination of the arthroscopic procedure
average mean arterial pressure
mean arterial pressure per operation.
Full Information
NCT ID
NCT04628676
First Posted
October 29, 2020
Last Updated
November 12, 2020
Sponsor
Haseki Training and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04628676
Brief Title
Comparison of the Efficacy of Irrigation With Epinephrine or Tranexamic Acid on Visual Clarity
Official Title
Comparison of the Efficacy of Irrigation With Epinephrine or Tranexamic Acid on Visual Clarity During Arthroscopic Rotator Cuff Repair: A Randomized Double-Blind Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
December 30, 2019 (Actual)
Study Completion Date
January 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Haseki Training and Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tears
Keywords
shoulder arthroscopy, irrigation, epinephrine, image quality, tranexamic acid, cuff tear repair, visual clarity
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TXA group
Arm Type
Experimental
Arm Description
tranexamic acid added to irrigation solution
Arm Title
EPN group
Arm Type
Experimental
Arm Description
epinephrine added to irrigation solution
Intervention Type
Drug
Intervention Name(s)
tranexamic acid
Other Intervention Name(s)
TRANSAMINE %5 5 ml 250 mg
Intervention Description
Tranexamic acid is added to the irrigation fluid used in arthroscopic shoulder surgery.
Intervention Type
Drug
Intervention Name(s)
Epinephrine
Other Intervention Name(s)
ADRENALIN 0,5 mg/1 m
Intervention Description
Epinephrine is added to the irrigation fluid used in arthroscopic shoulder surgery.
Primary Outcome Measure Information:
Title
Visual analog scale
Description
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.
Time Frame
through study completion, an average of 2 year
Secondary Outcome Measure Information:
Title
total operating time
Description
period in minutes from the time the arthroscope was inserted into the glenohumeral joint until the termination of the arthroscopic procedure
Time Frame
through study completion, an average of 2 year
Title
average mean arterial pressure
Description
mean arterial pressure per operation.
Time Frame
through study completion, an average of 2 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Haseki Training and Research Hospital
City
Istanbul
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
Comparison of the Efficacy of Irrigation With Epinephrine or Tranexamic Acid on Visual Clarity
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