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

NCT ID: NCT01939743

Last Updated: 2013-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2012-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Carcinoma Prostate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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diclofenac suppository plus lidocaine gel

Intervention Drug with local anaesthetic

Group Type EXPERIMENTAL

Diclofenac suppository plus lidocaine gel

Intervention Type DRUG

Lidocaine gel only

Intervention Type DRUG

Lidocaine gel only

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

Group Type OTHER

Lidocaine gel only

Intervention Type DRUG

Interventions

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Diclofenac suppository plus lidocaine gel

Intervention Type DRUG

Lidocaine gel only

Intervention Type DRUG

Other Intervention Names

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Voltral suppository

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

51 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Aga Khan University

OTHER

Sponsor Role lead

Responsible Party

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Naveed Haroon

Resident

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Naveed Haroon, MBBS

Role: PRINCIPAL_INVESTIGATOR

Aga Khan University

Locations

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Aga Khan University Hospital

Karachi, Sindh, Pakistan

Site Status

Countries

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Pakistan

References

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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.

Reference Type BACKGROUND
PMID: 16230141 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15017205 (View on PubMed)

Other Identifiers

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11GS009SUR

Identifier Type: -

Identifier Source: org_study_id