Rotator Cuff Tears Clinical Trial
Official title:
Effects of the Application of a New Pharmacological Protocol for Shoulder Arthroscopy in Beach Chair Position
Verified date | July 2023 |
Source | Clinic for Orthopedics Lovran |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Croatia | University orthopaedic and trauma hospital | Lovran | Primorsko Goranska |
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 |
Croatia,
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* Note: There are 26 references in all — Click here to view all references
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 |
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