Bladder instillation cocktail for preventing catheter-related bladder irritation after gynecologic surgery: a double-blind, randomized, placebo- controlled study

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Abstract

Background: Catheter-related bladder discomfort (CRBD) can lead to decreased patient satisfaction and increased postoperative adverse events. Although existing prevention methods for CRBD have demonstrated certain therapeutic effects, they may cause various adverse reactions. In this study, a "cocktail" reagent containing a combination of three drugs, including ropivacaine, dexamethasone, and magnesium sulfate, was used. This study aimed to investigate whether bladder instillation of a "cocktail" can prevent postoperative CRBD in gynecological patients. Methods: This double-blind, prospective, randomized controlled clinical study included 112 patients randomly divided into two groups: 56 patients in the "cocktail" group and 56 patients in the control group. Patients in the "cocktail" group received an intravesical infusion of the "cocktail" ("cocktail" formula included 20 mL of 1% ropivacaine + 5 g of magnesium sulfate injection + 10 mg of dexamethasone, all diluted to a total volume of 32 mL), while those in the control group received an intravesical infusion of 32 mL of physiological saline. After bladder instillation in all patients, the catheter was clamped for 20 min. The CRBD and visual analog scale (VAS) of the patients were recorded at 0, 1, 2, and 6 h after surgery. The 15-item Quality of Recovery (QoR-15) scale was used 24 h after surgery to assess the patient's postoperative recovery status. Results: The "cocktail" group exhibited significantly decreased CRBD severity at 0, 1, 2, and 6 h postoperatively ( P = 0.002, P < 0.001, P < 0.001, and P < 0.001, respectively). Specifically, compared with the control group, the "cocktail" group exhibited a significant decrease in moderate-to-severe CRBD at 0, 1, and 2 h postoperatively ( P = 0.040, P = 0.043, P = 0.031, respectively). Moreover, patients in the "cocktail" group exhibited significantly higher postoperative recovery scale scores compared to those in the control group ( P < 0.001). Conclusion: Bladder instillation of the "cocktail" can prevent catheter-related bladder irritation and improve postoperative recovery in gynecologic patients. Trial registration: This trial was a retrospective registration with the Chinese Clinical Trial Registry (No. ChiCTR2300078550), registered on December 12, 2023.

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