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

Primary Purpose

Carcinoma Prostate

Status
Completed
Phase
Phase 2
Locations
Pakistan
Study Type
Interventional
Intervention
Diclofenac suppository plus lidocaine gel
Lidocaine gel only
Sponsored by
Aga Khan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Carcinoma Prostate

Eligibility Criteria

51 Years - 70 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Aga Khan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

diclofenac suppository plus lidocaine gel

Lidocaine gel only

Arm Description

Intervention Drug with local anaesthetic

Used as local aneaethetic as a part of institutional prostate biopsy protocol

Outcomes

Primary Outcome Measures

Pain on visual analog score

Secondary Outcome Measures

Adverse effects of diclofenac suppository

Full Information

First Posted
April 1, 2013
Last Updated
September 7, 2013
Sponsor
Aga Khan University
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1. Study Identification

Unique Protocol Identification Number
NCT01939743
Brief Title
Efficacy of Diclofenac Suppository for Pain Control in Ultrasound Guided Biopsy of Prostate
Official Title
Diclofenac Suppository As a Preemptive Analgesia in Ultrasound Guided Biopsy of Prostate: Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aga Khan University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma Prostate

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
diclofenac suppository plus lidocaine gel
Arm Type
Experimental
Arm Description
Intervention Drug with local anaesthetic
Arm Title
Lidocaine gel only
Arm Type
Other
Arm Description
Used as local aneaethetic as a part of institutional prostate biopsy protocol
Intervention Type
Drug
Intervention Name(s)
Diclofenac suppository plus lidocaine gel
Other Intervention Name(s)
Voltral suppository
Intervention Type
Drug
Intervention Name(s)
Lidocaine gel only
Primary Outcome Measure Information:
Title
Pain on visual analog score
Time Frame
Two hours
Secondary Outcome Measure Information:
Title
Adverse effects of diclofenac suppository
Time Frame
two hours

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
51 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Naveed Haroon, MBBS
Organizational Affiliation
Aga Khan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aga Khan University Hospital
City
Karachi
State/Province
Sindh
ZIP/Postal Code
3500
Country
Pakistan

12. IPD Sharing Statement

Citations:
PubMed Identifier
16230141
Citation
Irer B, Gulcu A, Aslan G, Goktay Y, Celebi I. Diclofenac suppository administration in conjunction with lidocaine gel during transrectal ultrasound-guided prostate biopsy: prospective, randomized, placebo-controlled study. Urology. 2005 Oct;66(4):799-802. doi: 10.1016/j.urology.2005.04.053.
Results Reference
background
PubMed Identifier
15017205
Citation
Haq A, Patel HR, Habib MR, Donaldson PJ, Parry JR. Diclofenac suppository analgesia for transrectal ultrasound guided biopsies of the prostate: a double-blind, randomized controlled trial. J Urol. 2004 Apr;171(4):1489-91. doi: 10.1097/01.ju.0000115706.19605.e4.
Results Reference
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Efficacy of Diclofenac Suppository for Pain Control in Ultrasound Guided Biopsy of Prostate

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