Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma Prostate | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Diclofenac suppository plus lidocaine gel | Drug | — | UNRESOLVED |
| Lidocaine gel only | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- diclofenac suppository plus lidocaine gel
- description
- Intervention Drug with local anaesthetic
- interventionNames
- Drug: Diclofenac suppository plus lidocaine gel
- Drug: Lidocaine gel only
- type
- OTHER
- label
- Lidocaine gel only
- description
- Used as local aneaethetic as a part of institutional prostate biopsy protocol
- interventionNames
- Drug: Lidocaine gel only
Primary outcomes (1)
- measure
- Pain on visual analog score
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 51 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDIrer 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. PMID 16230141
- BACKGROUNDHaq 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. PMID 15017205