Riassunto dello studio

One hundred ninety-five patients with rotator cuff tears undergoing arthroscopic double-row repair were randomized to receive carbazochrome sodium sulfonate (CSS) 80 mg IV (n=65), Tranexamic acid (TXA) 100 mg IV (n=65), or 0.9% sodium chloride 60 mg IV (n=65), administered five minutes pre-incision and again three hours post-op via light-protected infusion (triple-blind). The primary outcome was intraoperative visual clarity (VCS) assessed during arthroscopic exam, subacromial work, and cuff repair. Secondary outcomes included operative duration, irrigation fluid volume, red-blood-cell count in discarded irrigation fluid, intraoperative mean blood pressure, inflammatory markers (CRP, IL-6, ESR), hemoglobin, VAS pain, and postoperative shoulder enlargement; labs and VAS were followed through postoperative day (POD) 3. Overall, the results showed CSS produced higher VC during subacromial treatment and cuff repair, with shorter operative time, less irrigation, lower RBC counts in fluid, less swelling, and lower early pain than TXA or placebo; inflammatory markers were lower with CSS and TXA versus placebo, and no drug-related adverse events were observed. These findings suggest IV CSS enhances visualization and operative efficiency without added safety signals in this setting.