Background: To compare the efficacy and safety of local infiltration anesthesia and mucous surface anesthesia in patients undergoing trans-rectal ultrasound-guided (TRUS guided) prostate biopsy. Methods: Patients with suspected prostate cancer undergoing TRUS guided prostate biopsy were randomly divided into two groups between January 2018 and March 2019. Local infiltration anesthesia was performed in the experimental group with lidocaine; while the control group was treated with mucous surface anesthesia. We collected baseline characteristics. Residual urine volume was measured twice: before biopsy, the first micturition after biopsy. Associated complications, positive rate of biopsy, visual analog pain scale (VAS) and Gleason score were recorded. Results: The study included 78 patients. The pain score of experimental group was significantly lower than the control group. Experimental group had lower rate of urinary retention and catheterization. Both groups had similar positive rate of biopsy, residual urine volume, Gleason score, fever and so on. Conclusion: Comparing with mucous surface anesthesia, local infiltration anesthesia relieved the pain better in patients undergoing TRUS guided prostate biopsy. It was more effective and safer. Trial registration: Chinese Clinical Trial Registry, Trial registration number (TRN): ChiCTR1800016424, Date of registration: 01/06/ 2018.
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