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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04628676
Enrollment
100
Registered
2020-11-13
Start date
2017-02-01
Completion date
2020-01-30
Last updated
2020-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rotator Cuff Tears

Keywords

shoulder arthroscopy, irrigation, epinephrine, image quality, tranexamic acid, cuff tear repair, visual clarity

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.

Interventions

DRUGtranexamic acid

Tranexamic acid is added to the irrigation fluid used in arthroscopic shoulder surgery.

DRUGEpinephrine

Epinephrine is added to the irrigation fluid used in arthroscopic shoulder surgery.

Sponsors

Haseki Training and Research Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Visual analog scalethrough study completion, an average of 2 yearVisual 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

MeasureTime frameDescription
total operating timethrough study completion, an average of 2 yearperiod in minutes from the time the arthroscope was inserted into the glenohumeral joint until the termination of the arthroscopic procedure
average mean arterial pressurethrough study completion, an average of 2 yearmean arterial pressure per operation.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026