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

Study Overview
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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.

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

Conditions
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Carcinoma Prostate

Intervention / Treatment
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* Drug: Diclofenac suppository plus lidocaine gel
* Drug: Lidocaine gel only


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 51 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: diclofenac suppository plus lidocaine gel<br>Intervention Drug with local anaesthetic | Drug: Diclofenac suppository plus lidocaine gel<br> <br> * Other names: Voltral suppository;Drug: Lidocaine gel only<br> <br> |
| Other: Lidocaine gel only<br>Used as local aneaethetic as a part of institutional prostate biopsy protocol | Drug: Lidocaine gel only<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain on visual analog score |  | Two hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse effects of diclofenac suppository |  | two hours |