Trial Design and Participants
This is a double-blinded, randomized controlled trial (RCT). Patients who underwent shoulder arthroscopic repair in our hospital from January 2021 to April 2019 were enrolled in this study. Inclusion criteria included patients diagnosed with rotator cuff tear and failure of conservative treatment for more than 3 months. We excluded patients who have coagulation disease or using anticoagulant drugs, those with thromboembolic disease such as myocardial infarction or deep venous thrombosis, those with atrial fibrillation or impairment of liver and kidney function. All patients were informed of the details of this trail, patients who refused to participate were excluded. For the patients with hypertension, the blood pressure should be controlled below 140 / 90mmHg, we consulted the department of cardiology if necessary. Transcranial Doppler ultrasound (TCD) were used for the screening of cerebral vascular stenosis (CVS), if TCD shows rapid cerebral arterial blood flow, further examination of craniocerebral magnetic resonance angiography were necessary, patients with CVS were excluded. All patients received a magnetic resonance imaging examination before their operation, according to cofild classification, massive rotator cuff tears were excluded from this trail. This study was approved by Ethics Committee of the Third Hospital of Hebei Medical University(2022-020-1).
Intervention And Randomization
Patients were randomly assigned to four groups in a 1:1:1:1 ratio. The four groups were control group, intravenous group, irrigation group, intravenous and irrigation group. TXA is produced by Shanxi Pude Pharmaceutical Co., Ltd. For intravenous group, TXA 1000 mg (100 mL) was given intravenously 10 minutes before surgery as previously mentioned [14]. For irrigation group, TXA solution (0.42 g of TXA per 1 L of saline) was used for irrigation fluid during subacromial decompression and acromioplasty procedure(SDAP) of the surgery. In intravenous and irrigation group, patients received TXA 1000 mg (100 mL) intravenous infusion 10 minutes before surgery, and irrigation fluid during SDAP was the same as irrigation group. The control group received neither TXA intravenous infusion and TXA irrigation.
Randomized grouping was conducted via a computer-generated randomization table. A sequence of random digits from 1 to 4 was generated, 1–4 correspond respectively to control group, intravenous group, irrigation group, intravenous and irrigation group. When a random number is generated, the patient will be assigned to corresponding group. The grouping procedure was accomplished by nurses in the ward, who didn't participate this study. Both the surgeons and patients were blinded as to which group they were assigned.
Anesthesia And Surgery
The surgery were performed with the patient in lateral position under tracheal intubation general anesthesia combined with forearm plexus block. All surgeries was performed by one experienced professor.Radio frequency cutter is produced by ArthroCare Corporation, shaver and bur is produced by Smith ༆ Nephew Inc. Intraoperative blood pressure was controlled by anesthesiologist, generally the high pressure was controlled at the level of 90–110 mmHg, The water pump pressure was about 20mmhg lower than the high pressure of blood during the surgery.
Outcome Measures
The primary outcome was the visual clarity, it was evaluated based on a visual analog scale (VAS). VAS has been previously described by Avery et al [13]. They rated the visual clarity into 11 scale (0–10) using the VAS system. Douwe O simplified the VAS into 3 scale (1–3) [15], visual clarity better than 7 was evaluated as good, worse than 3 was evaluated as poor, between 3 and 7 of was evaluated as fair. Yuan-Fu Liu proved 3-grade visual clarity have better intraobserver and interobserver validations than 10-grade visual clarity scoring system [16]. In this trail we evaluate visual clarity using 3 scale VAS system.
The secondary outcomes includes irrigation fluid consumption and time of SDAP of the surgery.
Statistical Method
Sample size was based on a priori power analysis model of a similar study [13]. In this model, At least 30 specimens in each group was needed. Considering the risk of dropouts, 140 patients were included for the four groups in trial. All statistical calculations were performed using SPSS software for Windows (version 25.0; IBM Corp, Armonk, NY). All parameters in this paper are quantitative data. Visual clarity was nonnormally distributed data and expressed by median (upper quartile, lower quartile). Visual clarity comparisons between each group were conducted using the Rank sum test. Irrigation fluid consumption and time of SDAP of the surgery were nonnormally distributed and were expressed by mean ± standard deviation (SD), comparisons between each group were conducted using ordinary one-way analysis of variance (ANOVA). Significance was set at a p-value < 0.05.