OBJECTIVE: The aim of this study was to determine the effect of intravenous (IV) tranexamic acid (TRX) use on visual clarity during arthroscopic rotator cuff repair. METHODS: This prospective, randomized, double-blinded, placebo-controlled study was conducted in patients scheduled for an arthroscopic rotator cuff repair. In total, 60 patients were randomly distributed into two groups: control (28 patients: 11 male, 17 female; mean age=53 years, age range=19-65) and TRX (32 patients: 15 male, 17 female; mean age=50, age range=18-69). In the TRX group, the arthroscopy was performed through the bolus IV administration of 10 mg/kg TRX in 100 ml isotonic saline solution. In the control group, the arthroscopy was performed through the bolus IV administration of 100 ml isotonic saline solution. In both the groups, the IV administration was carried out after the induction of anesthesia. At the end of each procedure, the surgeon rated the visual clarity on a scale from 1 to 10. In addition, operation time (minutes), irrigation amount used in operation (lt), and the need of pressure increase because of bleeding were recorded. RESULTS: No adverse effects were seen during the study period. Visual clarity in TRX group was significantly better than the control group (the mean visual clarity scores=8.1/10 (range=7-10) vs 7/10 (range=5-9); p=0.018). The amount of solution was significantly less in the TRX group (10.2 lt (range=3.5-21)) than in the control group (15.8 lt (range=5.8-27); p=0.007, post-hoc power=95.7%), although the operation time was slightly longer in the TRX group (106 minutes (range=50-210)) than in the control group (99 minutes (range=45-165); p=0.24). Moreover, the need for the increase in pressure owing to bleeding was found significantly less in the TRX group (5.8 times (range=(0-9)) than in the control group (9.6 times (range=0-13); p=0.04, post-hoc power=94.5%). CONCLUSION: Preoperative IV TRX administration seems to be effective in improving visual clarity and reducing the need for high pressure and the amount of irrigation fluid during the arthroscopic rotator cuff repair. LEVEL OF EVIDENCE: Level II, Therapeutic study.
RCT Entities:
OBJECTIVE: The aim of this study was to determine the effect of intravenous (IV) tranexamic acid (TRX) use on visual clarity during arthroscopic rotator cuff repair. METHODS: This prospective, randomized, double-blinded, placebo-controlled study was conducted in patients scheduled for an arthroscopic rotator cuff repair. In total, 60 patients were randomly distributed into two groups: control (28 patients: 11 male, 17 female; mean age=53 years, age range=19-65) and TRX (32 patients: 15 male, 17 female; mean age=50, age range=18-69). In the TRX group, the arthroscopy was performed through the bolus IV administration of 10 mg/kg TRX in 100 ml isotonic saline solution. In the control group, the arthroscopy was performed through the bolus IV administration of 100 ml isotonic saline solution. In both the groups, the IV administration was carried out after the induction of anesthesia. At the end of each procedure, the surgeon rated the visual clarity on a scale from 1 to 10. In addition, operation time (minutes), irrigation amount used in operation (lt), and the need of pressure increase because of bleeding were recorded. RESULTS: No adverse effects were seen during the study period. Visual clarity in TRX group was significantly better than the control group (the mean visual clarity scores=8.1/10 (range=7-10) vs 7/10 (range=5-9); p=0.018). The amount of solution was significantly less in the TRX group (10.2 lt (range=3.5-21)) than in the control group (15.8 lt (range=5.8-27); p=0.007, post-hoc power=95.7%), although the operation time was slightly longer in the TRX group (106 minutes (range=50-210)) than in the control group (99 minutes (range=45-165); p=0.24). Moreover, the need for the increase in pressure owing to bleeding was found significantly less in the TRX group (5.8 times (range=(0-9)) than in the control group (9.6 times (range=0-13); p=0.04, post-hoc power=94.5%). CONCLUSION: Preoperative IV TRX administration seems to be effective in improving visual clarity and reducing the need for high pressure and the amount of irrigation fluid during the arthroscopic rotator cuff repair. LEVEL OF EVIDENCE: Level II, Therapeutic study.
Authors: Alexander D Vara; Denise M Koueiter; Daphne E Pinkas; Ashok Gowda; Brett P Wiater; J Michael Wiater Journal: J Shoulder Elbow Surg Date: 2017-02-03 Impact factor: 3.019