OBJECTIVE: To compare the level of pain experienced by patients during transrectal ultrasound-guided prostatic biopsy using intrarectal 2% lidocaine gel versus plain lubricant gel. DESIGN: Prospective double-blind randomised controlled trial. SETTING: Regional hospital, Hong Kong. PATIENTS: From March 2002 to December 2003, patients who underwent ultrasound-guided prostate biopsy at a Geriatric Urology Centre. MAIN OUTCOME MEASURES: Pain and discomfort scores measured by horizontal visual analogue scales. RESULTS: A total of 338 consecutive patients were randomised to lidocaine gel or plain lubricant gel groups. The two groups were statistically similar in demographic and disease characteristics. There were no significant statistical differences in pain or discomfort score in the lidocaine gel and plain lubricant groups--pain score: 1.75 versus 1.79 (P=0.66) on day 0 and 0.21 versus 0.15 (P=0.97) on day 1; discomfort score: 0.79 versus 0.77 (P=0.86) on day 0 and 0.12 versus 0.12 (P=0.76) on day 1. No major complications were recorded in this cohort. CONCLUSIONS:Transrectal ultrasound-guided trucut biopsy of the prostate can be safely performed with no anaesthesia in Chinese patients. Pain and discomfort are minimal. It was found that 2% lidocaine gel has no statistical therapeutic or analgesic benefit over plain lubricant gel.
RCT Entities:
OBJECTIVE: To compare the level of pain experienced by patients during transrectal ultrasound-guided prostatic biopsy using intrarectal 2% lidocaine gel versus plain lubricant gel. DESIGN: Prospective double-blind randomised controlled trial. SETTING: Regional hospital, Hong Kong. PATIENTS: From March 2002 to December 2003, patients who underwent ultrasound-guided prostate biopsy at a Geriatric Urology Centre. MAIN OUTCOME MEASURES: Pain and discomfort scores measured by horizontal visual analogue scales. RESULTS: A total of 338 consecutive patients were randomised to lidocaine gel or plain lubricant gel groups. The two groups were statistically similar in demographic and disease characteristics. There were no significant statistical differences in pain or discomfort score in the lidocaine gel and plain lubricant groups--pain score: 1.75 versus 1.79 (P=0.66) on day 0 and 0.21 versus 0.15 (P=0.97) on day 1; discomfort score: 0.79 versus 0.77 (P=0.86) on day 0 and 0.12 versus 0.12 (P=0.76) on day 1. No major complications were recorded in this cohort. CONCLUSIONS: Transrectal ultrasound-guided trucut biopsy of the prostate can be safely performed with no anaesthesia in Chinese patients. Pain and discomfort are minimal. It was found that 2% lidocaine gel has no statistical therapeutic or analgesic benefit over plain lubricant gel.
Authors: Joon Se Jung; Hee Nam Moon; Jung Im Kim; Sang Rak Bae; Chang Hee Han; Bong Hee Park Journal: Int Urol Nephrol Date: 2021-09-30 Impact factor: 2.370