G Pareek1, N A Armenakas, J A Fracchia. 1. Division of Urology, Department of Surgery, Lenox Hill Hospital, 100 E. 77th Street, New York, NY 10021, USA.
Abstract
PURPOSE: We performed a randomized, double-blind, placebo controlled study to assess the safety and efficacy of periprostatic anesthesia administration during prostate biopsy. MATERIALS AND METHODS: From May to November 2000 transrectal ultrasound guided prostate biopsy was performed in 132 consecutive men due to an abnormal digital rectal examination and/or elevated prostate specific antigen. During biopsy 66 patients each were randomly assigned to receive an injection of 1% lidocaine or normal saline. Immediately after biopsy the pain score was recorded independently by patients and the physician using a 10-point linear scale. In addition, patients were given a descriptive questionnaire to be completed at home and mailed back within 2 weeks of biopsy. RESULTS:Mean patient perceived pain scores plus or minus standard deviation of 2.7 +/- 0.21 in the lidocaine and 4.7 +/- 0.26 in the saline groups were significantly different (p <0.0001), as were mean physician perceived scores of 2.9 +/- 0.27 and 5.1 +/- 0.34, respectively (p = 0.0001). Mean questionnaire scores for pain during biopsy of 2.3 +/- 0.13 in the lidocaine and 3.1 +/- 0.18 in the saline groups were also significantly different (p = 0.0006), as were mean questionnaire scores for pain after biopsy of 1.8 +/- 0.11 and 2.3 +/- 0.13, respectively (p <0.006). There were no adverse effects of injection. CONCLUSIONS: Our results show a significant benefit of periprostatic anesthesia over placebo in a randomized double-blind trial. This safe, simple and rapid technique should be applied at transrectal ultrasound guided prostate biopsy to limit undue patient discomfort.
RCT Entities:
PURPOSE: We performed a randomized, double-blind, placebo controlled study to assess the safety and efficacy of periprostatic anesthesia administration during prostate biopsy. MATERIALS AND METHODS: From May to November 2000 transrectal ultrasound guided prostate biopsy was performed in 132 consecutive men due to an abnormal digital rectal examination and/or elevated prostate specific antigen. During biopsy 66 patients each were randomly assigned to receive an injection of 1% lidocaine or normal saline. Immediately after biopsy the pain score was recorded independently by patients and the physician using a 10-point linear scale. In addition, patients were given a descriptive questionnaire to be completed at home and mailed back within 2 weeks of biopsy. RESULTS: Mean patient perceived pain scores plus or minus standard deviation of 2.7 +/- 0.21 in the lidocaine and 4.7 +/- 0.26 in the saline groups were significantly different (p <0.0001), as were mean physician perceived scores of 2.9 +/- 0.27 and 5.1 +/- 0.34, respectively (p = 0.0001). Mean questionnaire scores for pain during biopsy of 2.3 +/- 0.13 in the lidocaine and 3.1 +/- 0.18 in the saline groups were also significantly different (p = 0.0006), as were mean questionnaire scores for pain after biopsy of 1.8 +/- 0.11 and 2.3 +/- 0.13, respectively (p <0.006). There were no adverse effects of injection. CONCLUSIONS: Our results show a significant benefit of periprostatic anesthesia over placebo in a randomized double-blind trial. This safe, simple and rapid technique should be applied at transrectal ultrasound guided prostate biopsy to limit undue patient discomfort.
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