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Completed

NCT Number: NCT04628676

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

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.

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Key information

Conditions

Rotator Cuff Tears Rotator Cuff Injuries Rupture Shoulder Injuries Tendon Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Haseki Training and Research Hospital

Istanbul, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tranexamic Acid

Drug

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

Other names: TRANSAMINE %5 5 ml 250 mg

Epinephrine

Drug

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

Other names: ADRENALIN 0,5 mg/1 m

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. average mean arterial pressure

    Time frame: through study completion, an average of 2 year

    mean arterial pressure per operation.

Sponsors and collaborators

Lead sponsor

Haseki Training and Research Hospital

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Nov 13, 2020
Registry last updated
Nov 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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