Effect of Intravenous Tranexamic Acid on Visual Clarity During Shoulder Arthroscopy in the Beach Chair Position

Summary

Shoulder arthroscopy offers numerous advantages and has led to a continuous increase in procedural complexity. Adequate intraoperative visual clarity is essential for successful performance of the procedure and is primarily dependent on effective hemorrhage control.The aim of this prospective, double-blind, randomized controlled study is to evaluate the effect of intravenously administered tranexamic acid (TXA) on intraoperative visual clarity, perioperative blood loss, procedure duration, and early postoperative outcomes in patients undergoing shoulder arthroscopy in the beach chair position, an area for which limited data are currently available in the literature. In both the experimental and control groups, hemoglobin levels are measured in the irrigation fluid and in patients' blood samples obtained before and after surgery. Additional outcomes include intraoperative visual clarity, duration of the procedure, postoperative shoulder swelling, postoperative pain intensity, and analgesic consumption.This study applies established scientific methods to determine whether there is a justified basis for the introduction of TXA into routine clinical practice for shoulder arthroscopy.

Conditions

• Rotator Cuff Tears
• Hemorrhage, Surgical
• Shoulder Injuries

Interventions

DRUG

Tranexamic Acid Injectable Product

Patients from the experimental group will receive 10 minutes before the procedure 1 g of tranexamic acid in 100 ml of saline intravenously unlike the patients in the control group who will receive just sterile saline.

DRUG

Placebo

Patients from experimental group will receive 10 minutes before the procedure 1 g of tranexamic acid in 100 ml of saline intravenously unlike the patients in the control group who will receive just sterile saline.

Sponsors & Collaborators

• University orthopaedic and trauma hospital Lovran

  collaborator UNKNOWN

• University of Rijeka, The Faculty of Medicine

  collaborator UNKNOWN

• University of Zagreb, The Faculty of Kinesiology

  collaborator UNKNOWN

• Nikola Matejcic

  lead OTHER

Principal Investigators

• Nikola Matejcic, MD · University orthopaedic and trauma hospital Lovran, Croatia

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-05-24

Primary Completion

2023-07-21

Completion

2023-07-21

Countries

• Croatia

Study Locations