Efficacy of Diclofenac Suppository for Pain Control in Ultrasound Guided Biopsy of Prostate

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: Male

Summary

Transrectal ultrasound guided biopsy of prostate (TRUS-Bx) is widely used as accepted mode of investigation for prostate cancer in current urology practice. It is considered a minor procedure, which most of the patients tolerate, however 20% of patients refuse to undergo the redo procedure without any analgesia or anesthesia but on the other hand, some authors reveal that 65 to 90% of patients report pain ranging from mild to severe in intensity. Diclofenac is a local and systemic anti-inflammatory drug and it reduces local mediators involved in local pain.The purpose of this study is to find out the role of rectal administration of diclofenac suppositories as an adjunct to 2% xylocaine gel in alleviating intra and post procedural pain in prostatic biopsy with adequately calculated sample size and excluding the patients with contraindication to procedure or diclofenac administration as these were the shortcomings of previous studies.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Aga Khan University
• Treatments: Diclofenac; Lidocaine

Criteria

Inclusion Criteria:All male patients undergoing ultrasound guided prostate biopsy due to any one of the following:

• Raised prostate-specific antigen level (>4.0ng/ml) and palpable nodularity on digital rectal examination

• Palpable nodularity on digital rectal examination

• Hypo echoic lesion as compared to surrounding prostate on transrectal ultrasound

Exclusion Criteria:

• History of previous prostate biopsy

• Acute and/or chronic prostatitis or chronic pelvic pain syndrome

• Anal fissure, hemorrhoids, anal surgery

• Concomitant analgesic medication

• Chronic renal failure

• Allergy to diclofenac