Skip to main content
OpenTrials
Completed

NCT Number: NCT01939743

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Carcinoma Prostate Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

51 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Aga Khan University Hospital

Karachi, Sindh, 3500, Pakistan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diclofenac suppository plus lidocaine gel

Drug

Other names: Voltral suppository

Lidocaine gel only

Drug

Primary outcomes

  1. Pain on visual analog score

    Time frame: Two hours

Secondary outcomes

  1. Adverse effects of diclofenac suppository

    Time frame: two hours

Sponsors and collaborators

Lead sponsor

Aga Khan University

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Sep 11, 2013
Registry last updated
Sep 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.