- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04628676
Comparison of the Efficacy of Irrigation With Epinephrine or Tranexamic Acid on Visual Clarity
November 12, 2020 updated by: erhan bayram, Haseki Training and Research Hospital
Comparison of the Efficacy of Irrigation With Epinephrine or Tranexamic Acid on Visual Clarity During Arthroscopic Rotator Cuff Repair: A Randomized Double-Blind Study
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Istanbul, Turkey
- Haseki Training and Research Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: TXA group
tranexamic acid added to irrigation solution
|
Tranexamic acid is added to the irrigation fluid used in arthroscopic shoulder surgery.
Other Names:
|
Experimental: EPN group
epinephrine added to irrigation solution
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Epinephrine is added to the irrigation fluid used in arthroscopic shoulder surgery.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual analog scale
Time Frame: through study completion, an average of 2 year
|
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
Time Frame: through study completion, an average of 2 year
|
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
Time Frame: through study completion, an average of 2 year
|
mean arterial pressure per operation.
|
through study completion, an average of 2 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2017
Primary Completion (Actual)
December 30, 2019
Study Completion (Actual)
January 30, 2020
Study Registration Dates
First Submitted
October 29, 2020
First Submitted That Met QC Criteria
November 12, 2020
First Posted (Actual)
November 13, 2020
Study Record Updates
Last Update Posted (Actual)
November 13, 2020
Last Update Submitted That Met QC Criteria
November 12, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Wounds and Injuries
- Rupture
- Shoulder Injuries
- Tendon Injuries
- Rotator Cuff Injuries
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Fibrin Modulating Agents
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Tranquilizing Agents
- Psychotropic Drugs
- Antidepressive Agents
- Anti-Anxiety Agents
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Antifibrinolytic Agents
- Hemostatics
- Coagulants
- Monoamine Oxidase Inhibitors
- Adrenergic beta-Agonists
- Sympathomimetics
- Vasoconstrictor Agents
- Mydriatics
- Tranexamic Acid
- Epinephrine
- Tranylcypromine
Other Study ID Numbers
- Saglik Bilimleri University
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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