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

September 7, 2013 updated by: Naveed Haroon, Aga Khan University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 3500
        • Aga Khan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

47 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: diclofenac suppository plus lidocaine gel
Intervention Drug with local anaesthetic
Drug: Diclofenac suppository plus lidocaine gel
Other Names:
  • Voltral suppository
Drug: Lidocaine gel only
Other: Lidocaine gel only
Used as local aneaethetic as a part of institutional prostate biopsy protocol
Drug: Lidocaine gel only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain on visual analog score
Time Frame: Two hours
Two hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse effects of diclofenac suppository
Time Frame: two hours
two hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aga Khan University

Investigators

  • Principal Investigator: Naveed Haroon, MBBS, Aga Khan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

April 1, 2013

First Submitted That Met QC Criteria

September 7, 2013

First Posted (Estimate)

September 11, 2013

Study Record Updates

Last Update Posted (Estimate)

September 11, 2013

Last Update Submitted That Met QC Criteria

September 7, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11GS009SUR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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