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

  • Turkey
      • Istanbul, Turkey
        • Haseki Training and Research Hospital

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
Drug: tranexamic acid
Tranexamic acid is added to the irrigation fluid used in arthroscopic shoulder surgery.
Other Names:
  • TRANSAMINE %5 5 ml 250 mg
Experimental: EPN group
epinephrine added to irrigation solution
Drug: Epinephrine
Epinephrine is added to the irrigation fluid used in arthroscopic shoulder surgery.
Other Names:
  • ADRENALIN 0,5 mg/1 m

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.

Sponsor

Haseki Training and Research Hospital

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

Other Study ID Numbers

  • Saglik Bilimleri University (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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