INTRODUCTION: Transrectal ultrasound guided needle biopsy of prostate is considered a minor procedure but it is associated with significant discomfort and pain. Rectal administration of lidocaine gel during biopsy is safe, simple and effective with no major morbidity. Tramadol is used for relief of moderate to severe pain and the parenteral preparation has been used prior to prostate biopsy. Since TRUS-guided needle biopsy of the prostate is an outpatient procedure and both parenteral and oral tramadol are effective in moderate to severe pain, it is the purpose of this study to compare the efficacy of oral tramadol with that of rectally instilled lidocaine gel prior to TRUS guided needle biopsy of the prostate.

MATERIALS AND METHODS: All male patients fifty and above who had indications for prostatic biopsy were enrolled in the study. Twenty eight patients were randomized into 2 groups, the control (group 1) and experimental (group 2). In group 1, a placebo capsule was given 1 hour prior to the biopsy and 15cc of 2% lidocaine gel was administered intrarectally 10 minutes before the biopsy. In group 2, the patients received a capsule of tramadol 50mg 1 hour prior to the biopsy and 15cc of K-Y jelly was administered intrarectally 10 minutes prior to the biopsy. The VAS pain was measured during insertion of the probe, during the biopsy and 10 minutes after. The mean difference in pain scores per group were compared using the independent T-test.

RESULTS: Twenty eight patients completed the procedure, fourteen were randomized to receive intrarectal lidocaine gel and the other fourteen received oral tramadol. Results showed that oral tramadol demonstrated less pain during insertion of the ultrasound rectal probe 19.57+/-SD 10.82 versus 34.28 +/- SD 19.31 (p = 0.032). During the biopsy proper the, control group had a mean VAS score of 36.86 +/-SD 21.12 and the tramadol group had a mean VAS score of 32.29 +/-SD 19.01 which was not statistically significant (p=0.528).The VAS scores ten minutes after the biopsy showed that the tramadol group had a lower mean of 10.43 +/-SD 11.65 versus 15.79 +/-SD 16.81 for the lidocaine group which was not statistically significant (p = 0.409). Each group had a 21% (3/14) incidence of adverse events and comparison showed no statistical significant difference (p= 0.645).

DISCUSSION: Tramadol, with its dual mechanism of action provides a kind of combined/adjuvant pain therapy. The advantage of using tramadol is that it is a centrally acting analgesis which effectively decreases the pain during distention of the anal sphincter and insertion of the needle into the prostate gland. Conclusion: Our data confirms that both techniques of non-invasive methods of analgesia duirng prostate biopsy are efficacious in reducing patient pain and discomfort, however oral tramadol significantly decreased the pain during probe insertion and was noted to be cheaper.