Intravenous tranexamic acid ("TXA") and its effect on post-operative pain and stiffness in patients undergoing total shoulder arthroscopy and rotator cuff repair.

This will be a multicentre multisurgeon prospective doubleblinded randomized and controlled trial looking at the effectiveness of single dose intravenous administration of Tranexamic Acid (TXA) in patients undergoing shoulder arthroscopy and rotator cuff repair. The aim of this study is to extend Level I category evidence of the known benefits of TXA to shoulder arthroscopy and rotator cuff repair. The primary objective of this study is to test the hypothesis that systemic use of tranexamic acid decreases postoperative pain and stiffness. All consecutive patients presenting to an elective orthopaedic consultation indicated for shoulder arthroscopy and rotator cuff repair will be considered eligible for this study. After having been screened for inclusion and exclusion criteria, read the information sheet and signed the consent form, patients will be blindly randomized to one of 2 groups: Systemic TXA or Control. Patients’ general demographic characteristics such as age, sex, dominance, diagnosis and other relevant comorbidities will be collected in a deidentified database locked on a password-protected computer. During the surgery, patients will be administered either 2000mg of intravenous TXA or a placebo equivalent (saline solution). Analysed outcome variables will include: occurrence of postoperative haematoma, postoperative pain Visual Analog Scale (pVAS), range of motion at 8 weeks and 24 weeks.