Intravenous Carbazochrome Sodium Sulfonate Improves Visual Clarity in Patients Undergoing Arthroscopic Rotator Cuff Repair: A Randomised Controlled, Triple-Blinded, Prospective Study.

Abstract

Purpose: To investigate the clinical efficacy of intravenous carbazochrome sodium sulfonate (CSS), an oxidation substance of epinephrine, in improving visual clarity (VC), perioperative hemostasis, and anti-inflammatory effects during arthroscopic rotator cuff repair.

Methods: This was a single-center, single-surgeon, randomized, controlled, triple-blinded, prospective study. Between August 2023 and August 2024, 195 patients undergoing arthroscopic rotator cuff repair were enrolled and randomly assigned to 1 of 3 groups: Group A received an intravenous infusion of CSS; group B received an intravenous infusion of tranexamic acid; and group C received an intravenous infusion of 0.9% sodium chloride. Patients with massive rotator cuff tear, frozen shoulder, hypertension, severe liver or renal dysfunction, long-term use of anticoagulants or antiplatelet drugs, bleeding disorders, or severe cardiopulmonary diseases were excluded. After each surgical procedure, a trained and independent evaluator assessed the clarity of images based on the VC scale, and all related clinical outcomes were recorded. The primary outcome was arthroscopic VC. The secondary outcomes were operative duration, irrigation fluid volume, red blood cell count of discarded irrigation fluid samples, intraoperative mean blood pressure, inflammatory marker levels, hemoglobin levels, visual analog scale (VAS) pain score, and shoulder joint enlargement rate.

Results: In total, 195 patients were enrolled, and they were randomized into 1 of 3 groups: Group A comprised 65 patients (21 men and 44 women) with a mean age of 56.4 years; group B, 65 patients (29 men and 36 women) with a mean age of 57.0 years; and group C, 65 patients (24 men and 41 women) with a mean age of 56.7 years. VC scale scores were not significantly different during arthroscopic examination (5 [range, 4 to 5] in group A vs 5 [range, 4 to 5] in group B vs 5 [range, 4 to 5] in group C; P = .859), but group A had higher scores than groups B and C during subacromial treatment (5 [range, 5 to 5] vs 4 [range, 3 to 4] vs 3 [range, 2 to 3.5]; P < .001) and rotator cuff repair (5 [range, 5 to 5] vs 4 [range, 3 to 4] vs 3 [range, 3 to 4]; P < .001). Group A showed significant advantages over groups B and C in operative duration (50.4 ± 8.0 minutes vs 66.4 ± 13.7 minutes vs 70.2 ± 17.4 minutes; P < .001), intraoperative infusion volume (11,338.5 ± 1,381.0 mL vs 18,483.1 ± 1,808.7 mL vs 19,047.7 ± 1,984.1 mL; P < .001), postoperative shoulder joint enlargement rate (8.2% [range, 3.0% to 11.7%] vs 14.1% [range, 9.2% to 18.1%] vs 15.4% [range, 13.8% to 16.3%]; P < .001), and red blood cell count of discarded infusion samples (12.6 ± 2.3 × 10⁹/L vs 19.6 ± 2.0 × 10⁹/L vs 20.4 ± 2.2 × 10⁹/L; P < .001). On postoperative days (PODs) 1, 2, and 3, hemoglobin levels were significantly lower in group C than in groups A and B. Inflammatory marker levels on PODs 1, 2, and 3 were not significantly different between groups A and B (P > .05) but were significantly lower in groups A and B than in group C (P < .05). A total of 157 patients (80.51% of the overall cohort) showed a change in the VAS pain score that met the MCID threshold 3 days after surgery. VAS scores on PODs 1, 2, and 3 were lower in group A than in groups B and C (P < .05). No adverse drug reactions or surgical complications occurred in any patients.

Conclusions: CSS can effectively improve VC, reduce perioperative blood loss, decrease the inflammatory response, and alleviate early postoperative pain and shoulder joint swelling, and it does not increase the incidence of adverse reactions and complications.

Level of evidence: Level I, randomized clinical trial.