Arthroscopic rotator cuff repair performed with intra-articular tranexamic acid: could it provide improved visual clarity and less postoperative pain? A prospective, double-blind, randomized study of 63 patients

医学 可视模拟标度 氨甲环酸 外科 随机对照试验 安慰剂 肩袖 前瞻性队列研究 双盲 关节内 麻醉 骨关节炎 失血 病理 替代医学
作者
Celaleddin Bildik,Tuna Pehlivanoğlu
出处
期刊:Journal of Shoulder and Elbow Surgery [Elsevier]
卷期号:32 (2): 223-231 被引量:22
标识
DOI:10.1016/j.jse.2022.10.007
摘要

Background Tranexamic acid (TXA) has been widely used in orthopedic surgery with the aim of reducing intraoperative and postoperative bleeding, as well as bleeding-related complications. The purpose of this study was to assess whether intra-articular use of TXA during arthroscopic rotator cuff tear (RCT) repair could improve visual clarity, shorten the duration of the operation, and provide superior pain management as compared with placebo. Methods We conducted a prospective, randomized, double-blind, placebo-controlled study. Patients aged ≥18 years with a magnetic resonance imaging–confirmed RCT and a history of failed conservative treatment for ≥6 months were included. Patients with a history of coagulopathy; a history of cardiac, renal, or hepatic disease; a history of conservative treatment for <6 months; and/or acute RCTs were excluded. Visual clarity as the primary outcome was assessed using an arthroscopic visual scale comprising 5 grades—ranging from grade 1, best visual clarity, to grade 5, worst visual clarity (requiring conversion to open surgery)—after the procedure by the operating surgeon every 10 minutes throughout the video of the operation. Secondary outcomes were operative duration and postoperative pain scores. Results A total of 63 patients with similar demographic data (age and sex) and intraoperative mean arterial pressure were enrolled and randomized into 2 groups: The TXA group comprised 32 patients with a mean age of 56.46 years, and the placebo group comprised 31 patients with a mean age of 57.83 years. The TXA group was reported to have significantly superior visual clarity (mean arthroscopic visual scale score, 1.5 ± 0.5 vs. 2.86 ± 1.7; P < .001), with a significantly higher percentage of grade 1 visual clarity (78.1% vs. 32.2%, P < .001) and a significantly lower percentage of grade 4 visual clarity (0% vs. 3.2%, P = .003). Grade 5 visual clarity was not recorded in any patient in either group. The TXA group showed a significantly shorter operative duration (55.73 minutes vs. 67.26 minutes, P = .001) and superior pain scores at 8 hours (2.3 vs. 3.6, P = .002) and 24 hours (1.6 vs. 2.4, P < .001) postoperatively. No complications were recorded in either group. Conclusions This study showed that during arthroscopic rotator cuff repair procedures, intra-articular use of TXA was able to provide superior arthroscopic visual clarity while shortening the total operative duration significantly and providing significantly superior pain management in the first 8 and 24 hours postoperatively as compared with placebo. This study underlines the safety and efficacy of intra-articular TXA use in arthroscopic rotator cuff repair. Tranexamic acid (TXA) has been widely used in orthopedic surgery with the aim of reducing intraoperative and postoperative bleeding, as well as bleeding-related complications. The purpose of this study was to assess whether intra-articular use of TXA during arthroscopic rotator cuff tear (RCT) repair could improve visual clarity, shorten the duration of the operation, and provide superior pain management as compared with placebo. We conducted a prospective, randomized, double-blind, placebo-controlled study. Patients aged ≥18 years with a magnetic resonance imaging–confirmed RCT and a history of failed conservative treatment for ≥6 months were included. Patients with a history of coagulopathy; a history of cardiac, renal, or hepatic disease; a history of conservative treatment for <6 months; and/or acute RCTs were excluded. Visual clarity as the primary outcome was assessed using an arthroscopic visual scale comprising 5 grades—ranging from grade 1, best visual clarity, to grade 5, worst visual clarity (requiring conversion to open surgery)—after the procedure by the operating surgeon every 10 minutes throughout the video of the operation. Secondary outcomes were operative duration and postoperative pain scores. A total of 63 patients with similar demographic data (age and sex) and intraoperative mean arterial pressure were enrolled and randomized into 2 groups: The TXA group comprised 32 patients with a mean age of 56.46 years, and the placebo group comprised 31 patients with a mean age of 57.83 years. The TXA group was reported to have significantly superior visual clarity (mean arthroscopic visual scale score, 1.5 ± 0.5 vs. 2.86 ± 1.7; P < .001), with a significantly higher percentage of grade 1 visual clarity (78.1% vs. 32.2%, P < .001) and a significantly lower percentage of grade 4 visual clarity (0% vs. 3.2%, P = .003). Grade 5 visual clarity was not recorded in any patient in either group. The TXA group showed a significantly shorter operative duration (55.73 minutes vs. 67.26 minutes, P = .001) and superior pain scores at 8 hours (2.3 vs. 3.6, P = .002) and 24 hours (1.6 vs. 2.4, P < .001) postoperatively. No complications were recorded in either group. This study showed that during arthroscopic rotator cuff repair procedures, intra-articular use of TXA was able to provide superior arthroscopic visual clarity while shortening the total operative duration significantly and providing significantly superior pain management in the first 8 and 24 hours postoperatively as compared with placebo. This study underlines the safety and efficacy of intra-articular TXA use in arthroscopic rotator cuff repair.
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