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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01939743

Enrollment

100

Registered

2013-09-11

Start date

2011-10-31

Completion date

2012-10-31

Last updated

2013-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma Prostate

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.

Interventions

DRUGDiclofenac suppository plus lidocaine gel

DRUGLidocaine gel only

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

51 Years to 70 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Pain on visual analog score	Two hours

Secondary

Measure	Time frame
Adverse effects of diclofenac suppository	two hours

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026