Operative Bleeding, Postoperative Pain, Shoulder Arthroscopy
Conditions
Brief summary
Tranexamic acid has seen an increase in use over the past decade in hip and knee arthroplasty as well as spine surgery with more recent use seen in total shoulder arthroplasty (TSA). The mechanism of action of TXA is as a lysine analogue that competitively inhibits the conversion of plasminogen to plasmin thus resulting in its antifibrinolytic activity. Investigators have showed that compared with placebo TXA had a statistically significant effect on blood and postoperative hemoglobin levels in TSA. To date there are no studies investigating the effect of TXA in arthroscopy of any kind or studies examining the ability of TXA to aid in surgeon visualization in arthroscopic procedures. The investigators of this study will use change in pump pressure as a surrogate objective measure for surgeon visualization. The hypothesis is that participants who receive TXA will have a lower change in pump pressure compared to participants who do not receive TXA.
Interventions
DRUGTranexamic acid
Prior to surgery, the patient will receive 1 gram of IV TXA
Sponsors
Rothman Institute Orthopaedics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* participants aged 18-80 * participants with an ASA (American Society of Anesthesiologists) score 1-3 * participants with a surgical indication of full thickness small to massive rotator cuff tear.
Exclusion criteria
* pregnant females, * participants with a known allergy to tranexamic acid, * participants with active thromboembolic disease, * participants with seizure disorder, * participants with prior cerebrovascular accident (CVA), * history of cardiac stents or past history of thromboembolic disease, * presence of full-thickness subscapularis tear (\>50%), * participants with irreparable rotator cuff tears.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in operative factors | 2 hours | change in pump pressure (ΔP) during shoulder arthroscopy with a change in pump pressure of 15 mmHg set as the marker of surgeon visualization of the shoulder joint during surgery. |
| Postoperative pain | 7 days | Investigators will be measuring whether there is a decrease in participants pain after surgery as assessed by visual analog score 7 days after surgery |
Countries
United States
Outcome results
None listed