NCT01939743

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

Diclofenac Suppository As a Preemptive Analgesia in Ultrasound Guided Biopsy of Prostate: Randomized Controlled Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Aga Khan University · Academic / Other
• Sex: Male
• Age: 51 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Carcinoma Prostate

Interventions

Type	Name	Description
DRUG	Diclofenac suppository plus lidocaine gel
DRUG	Lidocaine gel only

Timeline

• Start date: 2011-10-01
• Primary completion: 2012-09-01
• Completion: 2012-10-01
• First posted: 2013-09-11
• Last updated: 2013-09-11

Locations

1 site across 1 country: Pakistan