Intravenous tranexamic acid (TXA) and its effect on post-operative pain and stiffness in patients undergoing total shoulder arthroscopy and rotator cuff repair.
Phase 4
Completed
- Conditions
- Pain and stiffness after shoulder arthroscopy and rotator cuff repairSurgery - Other surgeryAnaesthesiology - Other anaesthesiologyMusculoskeletal - Other muscular and skeletal disorders
- Registration Number
- ACTRN12617001074381
- Lead Sponsor
- Dr Benjamin Cass
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 98
Inclusion Criteria
1. Patients who have consented for shoulder arthroscopy and rotator cuff repair under one of the investigators.
2. Patients who are capable of and have given informed consent for their participation in this study.
Exclusion Criteria
1. Patients allergic to tranexamic acid
2. Patients with a failed rotator cuff repair requiring revision
3. Patients with history of deep venous thrombosis or pulmonary embolism
4. Patients with cardiovascular disease, including coronary disease or peripheral arteriopathy
5. Patients with renal or liver failure
6. Patients with a known coagulopathy
7. Patients that refuse a potential transfusion
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Range of Motion in the operated shoulder will be assessed using a goniometer and the ASES (American Shoulder and Elbow Society Score). Treatment group will be compared with control group. [8 weeks and 24 weeks post-surgery, with 24 weeks being the primary endpoint.];Pain in treatment group versus control group will be assessed using the 100mm visual analogue scale as well as a pain questionnaire which asks the patient to rate (from 1 to 10) their pain at its worst and at its best during the last 24 hours.[72 hours (3 days), 8 weeks and 24 weeks post-surgery, with 24 weeks being the primary endpoint.]
- Secondary Outcome Measures
Name Time Method Occurrence of postoperative haematoma as measured by data linkage to patient medical records.[Within 6 weeks after intervention commencement.]