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

NCT01939743 | Completed Phase 2 DMC

• 1 other identifier: 11GS009SUR
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Carcinoma Prostate

Outcome Measures

Primary Outcomes (1)

• Pain on visual analog score

  Two hours

Secondary Outcomes (1)

• Adverse effects of diclofenac suppository

  two hours

Study Arms (2)

diclofenac suppository plus lidocaine gel

EXPERIMENTAL

Intervention Drug with local anaesthetic

Drug: Diclofenac suppository plus lidocaine gel; Drug: Lidocaine gel only

Lidocaine gel only

OTHER

Used as local aneaethetic as a part of institutional prostate biopsy protocol

Drug: Lidocaine gel only

Interventions

Diclofenac suppository plus lidocaine gel DRUG

Also known as: Voltral suppository

diclofenac suppository plus lidocaine gel

Lidocaine gel only DRUG

Lidocaine gel only; diclofenac suppository plus lidocaine gel

Eligibility Criteria

• Age: 51 Years - 70 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aga Khan University: lead

Study Sites (1)

Aga Khan University Hospital

Karachi, Sindh, 3500, Pakistan

Location

Related Publications (2)

• 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.

  PMID: 16230141 BACKGROUND

• 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.

  PMID: 15017205 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Naveed Haroon, MBBS

  Aga Khan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: April 1, 2013
• First Posted: September 11, 2013
• Study Start: October 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: October 1, 2012
• Last Updated: September 11, 2013

Record last verified: 2013-09

Locations

PA (1)