TY - JOUR
T1 - Intravenous Administration of Tranexamic Acid Significantly Improved Clarity of the Visual Field in Arthroscopic Shoulder Surgery. A Prospective, Double-Blind, and Randomized Controlled Trial
AU - Liu, Yuan Fu
AU - Hong, Chih Kai
AU - Hsu, Kai Lan
AU - Kuan, Fa Chuan
AU - Chen, Yueh
AU - Yeh, Ming Long
AU - Su, Wei Ren
N1 - Funding Information:
The authors thank professor Miin-Jye Wen and his work team, Department of Statistics, National Cheng-Kung University, Tainan, Taiwan, for the assistance of statistic in this study. They also thank Medical Device R & D Core Laboratory, National Cheng Kung University Hospital, Tainan, Taiwan, for the assistance of this project. We also thank Skeleton Materials and Bio-compatibility Core Lab, Research Center of Clinical Medicine, National Cheng Kung University Hospital, Tainan, Taiwan, for the assistance of this project.
Publisher Copyright:
© 2019 Arthroscopy Association of North America
PY - 2020/3
Y1 - 2020/3
N2 - Purpose: To determine whether intravenous administration of tranexamic acid (TXA) before shoulder arthroscopic rotator cuff repair surgery can improve arthroscopy visual clarity. Methods: This was a prospective, double-blind, randomized, and placebo-controlled study. From May 2016 to April 2018, patients requiring arthroscopic rotator cuff repair were enrolled and randomly assigned to either the TXA group. receiving 1000 mg of TXA intravenously 10 minutes before surgery. or the placebo group. receiving the same volume of plain saline. Patients with pre-existing liver/renal disease, coagulopathy, or concurrent use of anticoagulation medications were excluded. Visual clarity was rated using a Numeric Rating Scale from grade 1 (poor) to grade 3 (clear) every 15 minutes throughout the surgery. Secondary outcomes included estimated perioperative blood loss, operative time, degree of shoulder swelling, postoperative subjective pain score, inpatient duration, and associated comorbidities were recorded. Both parametric and nonparametric methods were used for the statistical analysis. Results: In total, 72 patients were enrolled, 37 in the TXA group and 35 in the placebo group. The demographic data were similar between the 2 groups. Visual clarity was found to be significantly better in the TXA group, with a greater percentage of grade 3 vision clarity (53.7 ± 18.9 % vs 40.5 ± 22.1%, P = .036). The average visual score in the TXA group (2.5 ± 0.2) also was better than that of the control group (2.3 ± 0.3) (P = .048). The postoperative subjective pain score was significantly lower in the TXA group (3.0 ± 1.5) than in the control group (4.3 ± 2.0) (P = .009). In addition, postoperative analgesic usage was significant lower in the TXA groups (9.6 ± 9.7 morphine milligram equivalent) than in the control group (14.7 ± 13.4 morphine milligram equivalent) (P = .037). Other parameters, such as operative time, estimated perioperative blood loss, degree of shoulder swelling, and duration of inpatient stay were similar between the 2 groups. None of the patients developed complications after surgery. Conclusions: Intravenous administration of TXA is an alternative way to improve visual clarity in arthroscopic shoulder surgery. It also reduces subjective pain and analgesic consumption in the early postoperative period without significant side effects. Level of Evidence: Therapeutic studies level II.
AB - Purpose: To determine whether intravenous administration of tranexamic acid (TXA) before shoulder arthroscopic rotator cuff repair surgery can improve arthroscopy visual clarity. Methods: This was a prospective, double-blind, randomized, and placebo-controlled study. From May 2016 to April 2018, patients requiring arthroscopic rotator cuff repair were enrolled and randomly assigned to either the TXA group. receiving 1000 mg of TXA intravenously 10 minutes before surgery. or the placebo group. receiving the same volume of plain saline. Patients with pre-existing liver/renal disease, coagulopathy, or concurrent use of anticoagulation medications were excluded. Visual clarity was rated using a Numeric Rating Scale from grade 1 (poor) to grade 3 (clear) every 15 minutes throughout the surgery. Secondary outcomes included estimated perioperative blood loss, operative time, degree of shoulder swelling, postoperative subjective pain score, inpatient duration, and associated comorbidities were recorded. Both parametric and nonparametric methods were used for the statistical analysis. Results: In total, 72 patients were enrolled, 37 in the TXA group and 35 in the placebo group. The demographic data were similar between the 2 groups. Visual clarity was found to be significantly better in the TXA group, with a greater percentage of grade 3 vision clarity (53.7 ± 18.9 % vs 40.5 ± 22.1%, P = .036). The average visual score in the TXA group (2.5 ± 0.2) also was better than that of the control group (2.3 ± 0.3) (P = .048). The postoperative subjective pain score was significantly lower in the TXA group (3.0 ± 1.5) than in the control group (4.3 ± 2.0) (P = .009). In addition, postoperative analgesic usage was significant lower in the TXA groups (9.6 ± 9.7 morphine milligram equivalent) than in the control group (14.7 ± 13.4 morphine milligram equivalent) (P = .037). Other parameters, such as operative time, estimated perioperative blood loss, degree of shoulder swelling, and duration of inpatient stay were similar between the 2 groups. None of the patients developed complications after surgery. Conclusions: Intravenous administration of TXA is an alternative way to improve visual clarity in arthroscopic shoulder surgery. It also reduces subjective pain and analgesic consumption in the early postoperative period without significant side effects. Level of Evidence: Therapeutic studies level II.
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U2 - 10.1016/j.arthro.2019.10.020
DO - 10.1016/j.arthro.2019.10.020
M3 - Article
C2 - 31870749
AN - SCOPUS:85076849257
SN - 0749-8063
VL - 36
SP - 640
EP - 647
JO - Arthroscopy - Journal of Arthroscopic and Related Surgery
JF - Arthroscopy - Journal of Arthroscopic and Related Surgery
IS - 3
ER -