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

Carcinoma Prostate Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01939743
• Other study ID #: 11GS009SUR
• Status: Completed
• Phase: Phase 2
• First received: April 1, 2013
• Last updated: September 7, 2013
• Start date: October 2011
• Est. completion date: October 2012

Study information

• Verified date: September 2013
• Source: Aga Khan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Pakistan: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 51 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Carcinoma Prostate
• Prostatic Neoplasms

Intervention

Drug:
• Diclofenac suppository plus lidocaine gel

• Lidocaine gel only

Locations

Country	Name	City	State
Pakistan	Aga Khan University Hospital	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Aga Khan University

Country where clinical trial is conducted

Pakistan, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain on visual analog score		Two hours	No
Secondary	Adverse effects of diclofenac suppository		two hours	Yes