Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To our knowledge, no studies examining the use of TXA after shoulder arthroscopy in an outpatient setting have been published. This study will evaluate whether TXA reduces pain as measured by opioid consumption and a visual analog scale for pain (VAS) for the first 72 hours after surgery. Secondary outcomes will examine whether patients were satisfied overall with their postoperative pain control, whether the time to first opioid use is increased, and whether the surgeon perceives improved surgical visualization in patients who received TXA. We will also examine the number of times pump pressure was increased during the procedure to improve visualization.
We will conduct a double-blind, placebo-controlled randomized clinical trial (RCT) to assess if there is benefit to use of TXA in shoulder arthroscopy. The study will include patients scheduled for rotator cuff repair with or without concomitant procedures. Patients undergoing shoulder arthroscopy for any other reason will be excluded, including isolated labral repair, isolated distal clavicle excision, frozen shoulder, isolated decompression or debridement. Medical exclusion criteria will include allergy or known sensitivity to TXA, known renal disease with previously documented creatinine >1.5, history of coagulopathy, DVT or PE requiring ongoing anticoagulation, baseline long-acting opioid use, a documented history of COVID-19 infection within 90 days of surgery.
A total of 150 participants will be enrolled and randomized 1:1 to receive either a standard dose of TXA (1000 mg) or an equivalent volume of placebo (normal saline, NS) at the time of surgery. The primary outcome measure will be postoperative opioid consumption as measured by pill count for 72 hours, calculated as morphine equivalent dose (MED). Secondary outcome measures will include subjective measurement of pain as rated on the VAS, time to first opioid use, and patient satisfaction with postoperative pain management at 72 hours. Operative time, surgeon rating of overall visibility during the procedure, and number of times pump pressure was increased during the procedure will also be compared between groups.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients who receive TXA will exhibit less pain | Active Comparator | as measured by opioid consumption and VAS for the first 72 hours after surgery |
|
| Patients who receive placebo will have higher pain | Placebo Comparator | placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic acid | Drug | A total of 150 participants will be enrolled and randomized 1:1 to receive either a standard dose of TXA (1000 mg) or an equivalent volume of placebo (normal saline, NS) at the time of surgery. . |
| Measure | Description | Time Frame |
|---|---|---|
| primary outcome measure will be postoperative opioid consumption as measured by pill count for 72 hours, calculated as morphine equivalent dose (MED). | 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary outcome measures will be postoperative pain management satisfaction at 72 hours. | include VAS, time to first opioid use, and patient satisfaction | 72 hours |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Surgical exclusion criteria:
Medical exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Katherine Burns, MD | SSM Health Orthopedics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SSM Health- DePaul | Bridgeton | Missouri | 63044 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26942474 | Background | Lin ZX, Woolf SK. Safety, Efficacy, and Cost-effectiveness of Tranexamic Acid in Orthopedic Surgery. Orthopedics. 2016 Mar-Apr;39(2):119-30. doi: 10.3928/01477447-20160301-05. Epub 2016 Mar 4. | |
| 28768785 | Background | Pauzenberger L, Domej MA, Heuberer PR, Hexel M, Grieb A, Laky B, Blasl J, Anderl W. The effect of intravenous tranexamic acid on blood loss and early post-operative pain in total shoulder arthroplasty. Bone Joint J. 2017 Aug;99-B(8):1073-1079. doi: 10.1302/0301-620X.99B8.BJJ-2016-1205.R1. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| placebo | Other | saline |
|
| 28902659 | Background | Kirsch JM, Bedi A, Horner N, Wiater JM, Pauzenberger L, Koueiter DM, Miller BS, Bhandari M, Khan M. Tranexamic Acid in Shoulder Arthroplasty: A Systematic Review and Meta-Analysis. JBJS Rev. 2017 Sep;5(9):e3. doi: 10.2106/JBJS.RVW.17.00021. |
| 32305106 | Background | Hurley ET, Lim Fat D, Pauzenberger L, Mullett H. Tranexamic acid for the Latarjet procedure: a randomized controlled trial. J Shoulder Elbow Surg. 2020 May;29(5):882-885. doi: 10.1016/j.jse.2020.01.066. |
| 31870749 | Background | Liu YF, Hong CK, Hsu KL, Kuan FC, Chen Y, Yeh ML, Su WR. Intravenous Administration of Tranexamic Acid Significantly Improved Clarity of the Visual Field in Arthroscopic Shoulder Surgery. A Prospective, Double-Blind, and Randomized Controlled Trial. Arthroscopy. 2020 Mar;36(3):640-647. doi: 10.1016/j.arthro.2019.10.020. Epub 2019 Dec 20. |
| 26337246 | Background | Karaaslan F, Karaoglu S, Yurdakul E. Reducing Intra-articular Hemarthrosis After Arthroscopic Anterior Cruciate Ligament Reconstruction by the Administration of Intravenous Tranexamic Acid: A Prospective, Randomized Controlled Trial. Am J Sports Med. 2015 Nov;43(11):2720-6. doi: 10.1177/0363546515599629. Epub 2015 Sep 2. |
| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
Not provided
Not provided