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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| diclofenac suppository plus lidocaine gel | Experimental | Intervention Drug with local anaesthetic |
|
| Lidocaine gel only | Other | Used as local aneaethetic as a part of institutional prostate biopsy protocol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diclofenac suppository plus lidocaine gel | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pain on visual analog score | Two hours |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse effects of diclofenac suppository | two hours |
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Inclusion Criteria:All male patients undergoing ultrasound guided prostate biopsy due to any one of the following:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Naveed Haroon, MBBS | Aga Khan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aga Khan University Hospital | Karachi | Sindh | 3500 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16230141 | Background | 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. | |
| 15017205 | Background |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Lidocaine gel only |
| Drug |
|
| 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. |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |