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

NCT04628676 | Completed

• 1 other identifier: saglik bilimleri university
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Rotator Cuff Tears

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• total operating time

  through study completion, an average of 2 year

• average mean arterial pressure

  through study completion, an average of 2 year

Study Arms (2)

TXA group

EXPERIMENTAL

tranexamic acid added to irrigation solution

Drug: tranexamic acid

EPN group

EXPERIMENTAL

epinephrine added to irrigation solution

Drug: Epinephrine

Interventions

tranexamic acid DRUG

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

Also known as: TRANSAMINE %5 5 ml 250 mg

TXA group

Epinephrine DRUG

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

Also known as: ADRENALIN 0,5 mg/1 m

EPN group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Haseki Training and Research Hospital: lead

Study Sites (1)

Haseki Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

Tranexamic Acid; Epinephrine

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Ethanolamines; Amino Alcohols; Alcohols; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: medical doctor

Study Record Dates

• First Submitted: October 29, 2020
• First Posted: November 13, 2020
• Study Start: February 1, 2017
• Primary Completion: December 30, 2019
• Study Completion: January 30, 2020
• Last Updated: November 13, 2020

Record last verified: 2020-11

Locations

TU (1)