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

Sponsor

Haseki Training and Research Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04628676

Collaborator

(none)

100

Enrollment

Location

Arms

35.9

Actual Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rotator Cuff Tears	Drug: tranexamic acid Drug: Epinephrine	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Basic Science

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

Actual Study Start Date :

Feb 1, 2017

Actual Primary Completion Date :

Dec 30, 2019

Actual Study Completion Date :

Jan 30, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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