Our review revealed a great heterogeneity in definition , format , and values of what is considered a clinical ly relevant difference in pain in RCTs of analgesics , and st and ardizations are advisable
OBJECTIVE To describe the  pain decrease considered as clinical ly relevant when design ing a trial and reporting its results .
Combination of oral tramadol, acetaminophen and 1% lidocaine induced periprostatic nerve block for pain control during transrectal ultrasound guided biopsy of the prostate: a prospective, randomized, controlled trial.
PURPOSE Prostate biopsy for diagnosing cancer can be painful . Tramadol is a central ly acting analgesic used to treat many pain disorders . We determined whether administering oral tramadol and acetaminophen combined with 1 % lidocaine induced periprostatic nerve block would significantly decrease the pain experienced by patients during st and ard 10-core transrectal ultrasound guided needle biopsy of the prostate . MATERIAL S AND METHODS A total of 60 men who presented for diagnostic prostate biopsy were r and omized to receive placebo plus periprostatic 1 % lidocaine as the control group of 30 or 75 mg tramadol/650 mg acetaminophen orally plus periprostatic 1 % lidocaine as the experimental group of 30 before undergoing biopsy . Immediately after biopsy each patient was asked to rate the pain on a linear 10-point scale and a st and ard 6-point faces pain scale . Complications of pain medication administration in each group were noted and compared . RESULTS Pain medication administration was well tolerated by each study group except for lightheadedness/dizziness and itching in 1 patient each in the experimental group , and lightheadedness/dizziness in 1 patient in the control group . Overall patients in the experimental group reported a mean decrease + /- SD in the pain score of 2.3 + /- 2.4 on the scale of 1 to 10 ( p = 0.0008 ) and 1.11 + /- 1.25 on the scale of 0 to 5 compared with scores in controls ( p = 0.0009 ) . CONCLUSIONS Administering 75 mg tramadol/650 mg acetaminophen orally with periprostatic 1 % lidocaine before transrectal ultrasound guided prostate biopsy is a safe , easy and effective method of controlling pain during the biopsy procedure
Our review revealed a great heterogeneity in definition , format , and values of what is considered a clinical ly relevant difference in pain in RCTs of analgesics , and st and ardizations are advisable
OBJECTIVE To describe the  pain decrease considered as clinical ly relevant when design ing a trial and reporting its results .