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| Name | Class |
|---|---|
| University of Manitoba | OTHER |
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The purpose of this study is to determine if intravenous TXA is a safe alternative to epinephrine in improving arthroscopic shoulder visualization.
Primary Objectives
In the last twenty years, the use of arthroscopy to surgically manage shoulder pathologies has expanded in its indications. The interplay between increased indications, surgeon experience, and improvements in equipment have all propelled arthroscopic shoulder surgery to preferred treatment in managing instability, rotator cuff, and impingement pathology. Obtaining adequate visual clarity is paramount to performing the procedures safely, efficiently, and effectively.
A variety of methods have been employed to improve visualization. This includes tighter control of blood pressure, regional anesthetic, pressure controlled irrigation system, sealed cannulas, electrocautery devices, and injecting epinephrine into irrigation fluid. The use of epinephrine in irrigation fluid has been studied in literature. The results of a few randomized controlled trials demonstrate that the vasoconstrictive properties of epinephrine decrease blood flow and consequently, improves surgeon visualization. However, there has been reports of ventricular tachycardia, lethal arrhythmias, and epinephrine induced pulmonary edema in literature that suggests that the addition of epinephrine in irrigation fluid may have caused these adverse events. Therefore, it is important to examine other alternatives, such as TXA, that can decrease bleeding and improve visualization without potential detrimental effects.
This trial will be conducted in compliance with the protocol, GCP, and the applicable regulatory requirements.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No epinephrine or TXA | No Intervention | No intervention given. | |
| Epinephrine in irrigation fluid | Active Comparator | Epinephrine intervention used. |
|
| Intravenous TXA | Experimental | Tranexamic acid intervention used. |
|
| Epinephrine and TXA | Experimental | Epinephrine and tranexamic acid intervention used. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epinephrine | Drug | 1 mL of 1:1000 mixed into irrigation bag. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visualization Quality Scale | Surgeons are asked every 15 minutes to report on the quality of visualization based on a 4-point scale. Minimum value is 0, maximum value is 3 with the higher value reflecting improved visualization | Intra-operative |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Log Book for Pain and Medications | Patients are sent home from surgery with a log book to track the level of pain they are experiencing as well as the medications that they take. | Day of surgery - post-operative day 14 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jason Old, MD, FRCSC | Pan Am Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pan Am Clinic | Winnipeg | Manitoba | R3M 3E4 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11447543 | Background | Jensen KH, Werther K, Stryger V, Schultz K, Falkenberg B. Arthroscopic shoulder surgery with epinephrine saline irrigation. Arthroscopy. 2001 Jul;17(6):578-81. doi: 10.1053/jars.2001.23590. | |
| 8534296 | Background | Morrison DS, Schaefer RK, Friedman RL. The relationship between subacromial space pressure, blood pressure, and visual clarity during arthroscopic subacromial decompression. Arthroscopy. 1995 Oct;11(5):557-60. doi: 10.1016/0749-8063(95)90131-0. |
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| ID | Term |
|---|---|
| D000070636 | Rotator Cuff Injuries |
| D019534 | Shoulder Impingement Syndrome |
| ID | Term |
|---|---|
| D012421 | Rupture |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
| D013708 | Tendon Injuries |
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| ID | Term |
|---|---|
| D004837 | Epinephrine |
| D014148 | Tranexamic Acid |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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Surgeons are blinded to group allocation as all IV bags will have labels appearing identical when turned away from the surgeon. Anesthetists are told not to reveal allocation to the surgeon as well. And patients will not be informed of their allocation.
| Tranexamic acid | Drug | 1 g IV x 1 dose to be administered intraoperatively. |
|
|
| Epinephrine and Tranexamic Acid | Drug | 1 mL of 1:1000 epinephrine mixed into irrigation bag, and 1 g tranexamic acid x 1 dose to be administered intraoperatively. |
|
|
| 8534302 | Background | Ogilvie-Harris DJ, Weisleder L. Fluid pump systems for arthroscopy: a comparison of pressure control versus pressure and flow control. Arthroscopy. 1995 Oct;11(5):591-5. doi: 10.1016/0749-8063(95)90137-x. |
| 25442659 | Background | Avery DM 3rd, Gibson BW, Carolan GF. Surgeon-rated visualization in shoulder arthroscopy: a randomized blinded controlled trial comparing irrigation fluid with and without epinephrine. Arthroscopy. 2015 Jan;31(1):12-8. doi: 10.1016/j.arthro.2014.08.010. Epub 2014 Nov 6. |
| 26524933 | Background | van Montfoort DO, van Kampen PM, Huijsmans PE. Epinephrine Diluted Saline-Irrigation Fluid in Arthroscopic Shoulder Surgery: A Significant Improvement of Clarity of Visual Field and Shortening of Total Operation Time. A Randomized Controlled Trial. Arthroscopy. 2016 Mar;32(3):436-44. doi: 10.1016/j.arthro.2015.08.027. |
| 12728044 | Background | Mazzocca AD, Meneghini RM, Chhablani R, Badrinath SK, Cole BJ, Bush-Joseph CA. Epinephrine-induced pulmonary edema during arthroscopic knee surgery. A case report. J Bone Joint Surg Am. 2003 May;85(5):913-5. doi: 10.2106/00004623-200305000-00023. No abstract available. |
| 19184069 | Background | Cho SH, Yi JW, Kwack YH, Park SW, Kim MK, Rhee YG. Ventricular tachycardia during arthroscopic shoulder surgery: a report of two cases. Arch Orthop Trauma Surg. 2010 Mar;130(3):353-6. doi: 10.1007/s00402-009-0820-1. Epub 2009 Jan 29. |
| 10876433 | Background | Karns JL. Epinephrine-induced potentially lethal arrhythmia during arthroscopic shoulder surgery: a case report. AANA J. 1999 Oct;67(5):419-21. |
| 22397329 | Background | McCormack PL. Tranexamic acid: a review of its use in the treatment of hyperfibrinolysis. Drugs. 2012 Mar 26;72(5):585-617. doi: 10.2165/11209070-000000000-00000. |
| 16156456 | Background | Johansson T, Pettersson LG, Lisander B. Tranexamic acid in total hip arthroplasty saves blood and money: a randomized, double-blind study in 100 patients. Acta Orthop. 2005 Jun;76(3):314-9. |
| 8636182 | Background | Benoni G, Fredin H. Fibrinolytic inhibition with tranexamic acid reduces blood loss and blood transfusion after knee arthroplasty: a prospective, randomised, double-blind study of 86 patients. J Bone Joint Surg Br. 1996 May;78(3):434-40. |
| 22623147 | Background | Yang ZG, Chen WP, Wu LD. Effectiveness and safety of tranexamic acid in reducing blood loss in total knee arthroplasty: a meta-analysis. J Bone Joint Surg Am. 2012 Jul 3;94(13):1153-9. doi: 10.2106/JBJS.K.00873. |
| 23615973 | Background | Zhou XD, Tao LJ, Li J, Wu LD. Do we really need tranexamic acid in total hip arthroplasty? A meta-analysis of nineteen randomized controlled trials. Arch Orthop Trauma Surg. 2013 Jul;133(7):1017-27. doi: 10.1007/s00402-013-1761-2. Epub 2013 Apr 25. |
| 22161917 | Background | Alshryda S, Sarda P, Sukeik M, Nargol A, Blenkinsopp J, Mason JM. Tranexamic acid in total knee replacement: a systematic review and meta-analysis. J Bone Joint Surg Br. 2011 Dec;93(12):1577-85. doi: 10.1302/0301-620X.93B12.26989. |
| 24075404 | Background | Huang F, Wu D, Ma G, Yin Z, Wang Q. The use of tranexamic acid to reduce blood loss and transfusion in major orthopedic surgery: a meta-analysis. J Surg Res. 2014 Jan;186(1):318-27. doi: 10.1016/j.jss.2013.08.020. Epub 2013 Sep 13. |
| 21196541 | Background | Sukeik M, Alshryda S, Haddad FS, Mason JM. Systematic review and meta-analysis of the use of tranexamic acid in total hip replacement. J Bone Joint Surg Br. 2011 Jan;93(1):39-46. doi: 10.1302/0301-620X.93B1.24984. |
| 23643299 | Background | Tan J, Chen H, Liu Q, Chen C, Huang W. A meta-analysis of the effectiveness and safety of using tranexamic acid in primary unilateral total knee arthroplasty. J Surg Res. 2013 Oct;184(2):880-7. doi: 10.1016/j.jss.2013.03.099. Epub 2013 Apr 25. |
| D007592 |
| Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D000588 |
| Amines |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |