The Aim of This Study is to Examine the Effect of Intravenously Administered Tranexamic Acid (TXA) on the Visual Clarity, Perioperative Hemorrhage, Duration and Early Postoperative Course of Shoulder Arthroscopy in Beach Chair Position.
Condition: Rotator Cuff Tears; Hemorrhage, Surgical; Shoulder Injuries
MeSH terms: Hemorrhage; Blood Loss, Surgical; Rotator Cuff Injuries; Shoulder Injuries
Study type: Interventional
Phase: Phase 4

Summary: 
      Shoulder arthroscopy provides many benefits with a permanent increase in the possibilities
      and complexity of the application. A condition to perform it is intraoperative visual clarity
      dependent on hemorrhage control. The aim of this prospective, double blind, randomized, and
      controlled study is to examine the effect of intravenously administered tranexamic acid (TXA)
      on the visual clarity, perioperative hemorrhage, duration and early postoperative course of
      shoulder arthroscopy in beach chair position, which is not yet available in the literature.
      In the tested and control group, the investigators measure hemoglobin (Hb) in the waste
      irrigation fluid and the patient's blood before and after the procedure, visual clarity,
      duration of the procedure, postoperative shoulder swelling, pain level and analgesic drug
      consumption. The research uses scientific methods to determine if there is a reasonable basis
      for introducing TXA into routine clinical use.
    

Detailed description: 
      All surgical procedures will be performed at the University orthopaedic and trauma hospital
      Lovran, Croatia. Upon arrival at the hospital, the patient's body weight and height will be
      recorded. One day before the procedure, the patient will have blood taken from a vein and a
      complete blood count will be analyzed. Immediately before the procedure, patients will
      receive regional infiltrative (interscalene block) and general anesthesia with airway
      protection by endotracheal tube or laryngeal mask. Patients in the experimental group will
      receive 1 g of tranexamic acid in 100 ml of sterile saline IV 10 min before the start of the
      procedure, while patients in the control group will receive only sterile saline. The position
      of the patients will be beach chair with the head in the protective helmet and the arm in the
      front traction of 2-3 kg. All patients will be operated on by the same surgeon (NM) with the
      usual equipment: 4.5 mm 30° arthroscopic lens, arthroscopic pump basically set to 50 mmHg
      with the possibility of pulse increase of pressure by 20 mmHg for 2 min as needed,
      radiofrequency ablator and arthroscopic shaver system. Tendon reconstructions and shoulder
      stabilization will be performed in the usual way with suture anchors. During the procedure,
      the visual clarity on the endoscope screen (Visual analog scale VAS range: 0 worst visual
      clarity - 10 best visual clarity) will be evaluated by the surgeon every 15 minutes and the
      screen will be photographed at the same time. Screen photos will be presented after surgery
      to three independent surgeons with experience in arthroscopy on visual clarity estimation
      (VAS range 0-10). During the procedure, the number of times the pump pressure is increased
      will be counted. At the end of the surgery, the mean arterial pressure (MAP) will be noted,
      the exact amount of irrigation fluid consumed and the duration of the procedure from the
      first incision to the last skin suture will be calculated. A homogenized sample will be taken
      from the total volume of the waste solution in which the Hb concentration will be determined
      by a spectrophotometer using the Cripps method (University of Rijeka, Medical Faculty;
      spectrophotometer Varian Cary 100 Bio 190-900 nm, resolution ≤ 0.189 nm, wavelength accuracy
      of ± 0.02 nm to ± 0.04 nm). On the first day after the surgery, the shoulder circumference
      will be measured at 3 typical sites and the level of pain will be noted (VAS range 0 no pain
      -10 the strongest pain). On the second day, the shoulder circumference measurement and
      estimation of the level of pain will be repeated. Also blood will be taken from a vein and
      complete blood count will be repeated. During the postoperative period, the amount and type
      of analgesic drugs administered and the length of hospitalization will be monitored.
    

Intervention name(s): Tranexamic Acid Injectable Product; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 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.; 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.
Intervention MeSH terms: Tranexamic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Arthroscopy; Hemorrhage; Shoulder; Tranexamic acid