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

Not Applicable

Completed

• Conditions: Rotator Cuff Tears
• Interventions: Drug: Epinephrine; Drug: tranexamic acid

• Registration Number: NCT04628676
• Lead Sponsor: Haseki Training and Research Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-01
• Primary Completion: 2019-12-30
• Study Completion: 2020-01-30
• Study First Submitted: 2020-10-29
• Status Verified: 2020-11
• Study First Submitted QC: 2020-11-12
• Last Update Submitted: 2020-11-12
• Study First Posted: 2020-11-13
• Last Update Posted: 2020-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EPN group	Epinephrine	epinephrine added to irrigation solution
TXA group	tranexamic acid	tranexamic acid added to irrigation solution

Primary Outcome Measures

Name	Time	Method
Visual analog scale	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 Outcome Measures

Name	Time	Method
total operating time	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
average mean arterial pressure	through study completion, an average of 2 year	mean arterial pressure per operation.

Trial Locations

Locations (1)

Haseki Training and Research Hospital; 🇹🇷 Istanbul, Turkey