Clinical trial NCT01939743: Efficacy of Diclofenac Suppository for Pain Control in Ultrasound Guided Biopsy of Prostate
Official title: Diclofenac Suppository As a Preemptive Analgesia in Ultrasound Guided Biopsy of Prostate: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoma Prostate
Lead sponsor: Aga Khan University
Sponsor class: OTHER
First posted: 2013-09-11
Enrollment: 100
Sex: MALE
Minimum age (years): 51
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Pain on visual analog score
timeFrame: Two hours
Secondary outcomes:
measure: Adverse effects of diclofenac suppository
timeFrame: two hours
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Aga Khan University Hospital
state: Sindh
Study officials:
affiliation: Aga Khan University
name: Naveed Haroon, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.