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

Rotator Cuff Tears Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04628676
• Other study ID #: saglik bilimleri university
• Status: Completed
• Phase: N/A
• Start date: February 1, 2017
• Est. completion date: January 30, 2020

Study information

• Verified date: November 2020
• Source: Haseki Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 30, 2020
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Tears

Intervention

Drug:
• tranexamic acid
Tranexamic acid is added to the irrigation fluid used in arthroscopic shoulder surgery.
• Epinephrine
Epinephrine is added to the irrigation fluid used in arthroscopic shoulder surgery.

Locations

Country	Name	City	State
Turkey	Haseki Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Haseki Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	through study completion, an average of 2 year
Secondary	total operating time	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
Secondary	average mean arterial pressure	mean arterial pressure per operation.	through study completion, an average of 2 year