Yuan-Fu Liu1, Chih-Kai Hong1, Kai-Lan Hsu2, Fa-Chuan Kuan2, Yueh Chen3, Ming-Long Yeh4, Wei-Ren Su5. 1. Department of Orthopaedic Surgery, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan. 2. Department of Orthopaedic Surgery, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan; Department of Biomedical Engineering, National Cheng Kung University, Tainan, Taiwan. 3. Department of Orthopaedic Surgery, Sin Lau Christian Hospital, Tainan, Taiwan. 4. Department of Biomedical Engineering, National Cheng Kung University, Tainan, Taiwan; Medical Device Innovation Center, National Cheng Kung University, Tainan, Taiwan. 5. Department of Orthopaedic Surgery, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan; Skeleton Materials and Bio-compatibility Core Lab, Research Center of Clinical Medicine, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan. Electronic address: suwr@ms28.hinet.net.
Abstract
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.
RCT Entities:
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.
Authors: Carola F van Eck; Tim A C van Meel; Michel P J van den Bekerom; Jacco A C Zijl; Bauke Kooistra Journal: Arthrosc Sports Med Rehabil Date: 2021-02-23