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.

Rotator Cuff Tears Clinical Trial

Official title:

Effects of the Application of a New Pharmacological Protocol for Shoulder Arthroscopy in Beach Chair Position

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05397652
• Other study ID #: MATTXA2022
• Status: Completed
• Phase: Phase 4
• Start date: May 24, 2021
• Est. completion date: July 21, 2023

Study information

• Verified date: July 2023
• Source: Clinic for Orthopedics Lovran
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: July 21, 2023
• Est. primary completion date: July 21, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• rotator cuff tear

• instability of the glenohumeral joint

• instability of the acromioclavicular joint

Exclusion Criteria:

• allergy to tranexamic acid

• deep vein thrombosis

• congenital thrombophilia

• coagulopathy

• thromboembolic events last 12 months

• stroke or acute coronary syndrome last 3 months

• renal failure

• cirrhosis of the liver

• glaucoma or retinal vascular disorder

• chronic treatment with anticoagulant therapy

• uncontrolled hypertension

Related Conditions & MeSH terms

• Blood Loss, Surgical
• Hemorrhage
• Hemorrhage, Surgical
• Rotator Cuff Injuries
• Rotator Cuff Tears
• Shoulder Injuries

Intervention

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.
• 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.

Locations

Country	Name	City	State
Croatia	University orthopaedic and trauma hospital	Lovran	Primorsko Goranska

Sponsors (4)

Lead Sponsor	Collaborator
Nikola Matejcic	University of Rijeka, The Faculty of Medicine, University of Zagreb, The Faculty of Kinesiology, University orthopaedic and trauma hospital Lovran

Country where clinical trial is conducted

Croatia, 

References & Publications (26)

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* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual clarity on endoscope screen during shoulder arthroscopy	The surgeon will evaluate visual clarity using Visual analog scale range from 0 (worst visual clarity) -10 (best visual clarity) every 15 minutes during shoulder arthroscopy and screen will be photographed at the same time	At the very beginning of the shoulder arthroscopy
Primary	Visual clarity on endoscope screen during shoulder arthroscopy	The surgeon will evaluate visual clarity using Visual analog scale range from 0 (worst visual clarity) -10 (best visual clarity) every 15 minutes during shoulder arthroscopy and screen will be photographed at the same time	After 15 minutes since the beginning of the surgery
Primary	Visual clarity on endoscope screen during shoulder arthroscopy	The surgeon will evaluate visual clarity using Visual analog scale range from 0 (worst visual clarity) -10 (best visual clarity) every 15 minutes during shoulder arthroscopy and screen will be photographed at the same time	After 30 minutes since the beginning of the surgery
Primary	Visual clarity on endoscope screen during shoulder arthroscopy	The surgeon will evaluate visual clarity using Visual analog scale range from 0 (worst visual clarity) -10 (best visual clarity) every 15 minutes during shoulder arthroscopy and screen will be photographed at the same time	After 45 minutes since the beginning of the surgery
Primary	Visual clarity on endoscope screen during shoulder arthroscopy	The surgeon will evaluate visual clarity using Visual analog scale range from 0 (worst visual clarity) -10 (best visual clarity) every 15 minutes during shoulder arthroscopy and screen will be photographed at the same time	After 60 minutes since the beginning of the surgery
Primary	Visual clarity on endoscope screen during shoulder arthroscopy	The surgeon will evaluate visual clarity using Visual analog scale range from 0 (worst visual clarity) -10 (best visual clarity) every 15 minutes during shoulder arthroscopy and screen will be photographed at the same time	After 75 minutes since the beginning of the surgery
Primary	Visual clarity on endoscope screen during shoulder arthroscopy	The surgeon will evaluate visual clarity using Visual analog scale range from 0 (worst visual clarity) -10 (best visual clarity) every 15 minutes during shoulder arthroscopy and screen will be photographed at the same time	After 90 minutes since the beginning of the surgery
Primary	Visual clarity on endoscope screen during shoulder arthroscopy	The surgeon will evaluate visual clarity using Visual analog scale range from 0 (worst visual clarity) -10 (best visual clarity) every 15 minutes during shoulder arthroscopy and screen will be photographed at the same time	After 105 minutes since the beginning of the surgery
Primary	Visual clarity on endoscope screen during shoulder arthroscopy	The surgeon will evaluate visual clarity using Visual analog scale range from 0 (worst visual clarity) -10 (best visual clarity) every 15 minutes during shoulder arthroscopy and screen will be photographed at the same time	After 120 minutes since the beginning of the surgery
Primary	Visual clarity on endoscope screen during shoulder arthroscopy	The surgeon will evaluate visual clarity using Visual analog scale range from 0 (worst visual clarity) -10 (best visual clarity) every 15 minutes during shoulder arthroscopy and screen will be photographed at the same time	After 135 minutes since the beginning of the surgery
Primary	Visual clarity on endoscope screen during shoulder arthroscopy	The surgeon will evaluate visual clarity using Visual analog scale range from 0 (worst visual clarity) -10 (best visual clarity) every 15 minutes during shoulder arthroscopy and screen will be photographed at the same time	After 150 minutes since the beginning of the surgery
Primary	Visual clarity on endoscope screen during shoulder arthroscopy	Screen photos taken every 15 minutes during shoulder arthroscopy will be presented after surgery to three independent surgeons with experience in arthroscopy on visual clarity estimation using Visual analog scale range from 0 (worst visual clarity) -10 (best visual clarity)	Through study completion, an average of 1 year
Primary	Perioperative blood loss	The investigators will measure hemoglobin (Hb mg/100 mL) in the waste irrigation fluid collected during the surgery	Right after the surgery
Primary	Perioperative blood loss	The investigators will measure hemoglobin (Hb g/L) in the patient's blood before and after the procedure	1 day before the surgery
Primary	Perioperative blood loss	The investigators will measure hemoglobin (Hb g/L) in the patient's blood before and after the procedure	2nd day after the surgery
Primary	Early postoperative course of shoulder arthroscopy	The investigators will measure postoperative shoulder swelling. Shoulder circumference will be measured in centimeters (cm) at 3 typical sites one day before the surgery and 1st and 2nd day after the surgery	One day before the surgery
Primary	Early postoperative course of shoulder arthroscopy	The investigators will measure postoperative shoulder swelling. Shoulder circumference will be measured in centimeters (cm) at 3 typical sites one day before the surgery and 1st and 2nd day after the surgery	1st day after the surgery
Primary	Early postoperative course of shoulder arthroscopy	The investigators will measure postoperative shoulder swelling. Shoulder circumference will be measured in centimeters (cm) at 3 typical sites one day before the surgery and 1st and 2nd day after the surgery	2nd day after the surgery
Primary	Early postoperative course of shoulder arthroscopy	The investigators will measure postoperative pain level with Visual analog scale range from 0 (no pain) - 10 (the strongest pain)	1st postoperative day
Primary	Early postoperative course of shoulder arthroscopy	The investigators will measure postoperative pain level with Visual analog scale range from 0 (no pain) - 10 (the strongest pain)	2nd postoperative day
Primary	Early postoperative course of shoulder arthroscopy	The investigators will measure analgesic drug consumption (mg of peroral or injectable product of paracetamol)	During hospitalization (up to 7 days)
Primary	Early postoperative course of shoulder arthroscopy	The investigators will measure analgesic drug consumption (mg of peroral or injectable product of ketoprofen)	During hospitalization (up to 7 days)
Primary	Early postoperative course of shoulder arthroscopy	The investigators will measure analgesic drug consumption (mg of injectable product of metamizole)	During hospitalization (up to 7 days)
Primary	Early postoperative course of shoulder arthroscopy	The investigators will measure analgesic drug consumption (mg of injectable product of tramadol)	During hospitalization (up to 7 days)
Secondary	Difference in blood loss between different indications for performing shoulder arthroscopy	The investigators will measure hemoglobin (Hb mg/100 mL) in the waste irrigation fluid collected during the different types of shoulder arthroscopy	Right after the surgery
Secondary	Difference in blood loss between different indications for performing shoulder arthroscopy	The investigators will measure hemoglobin (Hb g/L) in the patient's blood before and after the different types of shoulder arthroscopy	1 day before the surgery
Secondary	Difference in blood loss between different indications for performing shoulder arthroscopy	The investigators will measure hemoglobin (Hb g/L) in the patient's blood before and after the different types of shoulder arthroscopy	2nd day after the surgery