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

• Sponsor: Aga Khan University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01939743
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Duration (Months): 12
• Patients Per Site Per Month: 8.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Carcinoma Prostate	Drug: Diclofenac suppository plus lidocaine gel; Drug: Lidocaine gel only	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Diclofenac Suppository As a Preemptive Analgesia in Ultrasound Guided Biopsy of Prostate: Randomized Controlled Trial
• Study Start Date: Oct 1, 2011
• Actual Primary Completion Date: Sep 1, 2012
• Actual Study Completion Date: Oct 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: diclofenac suppository plus lidocaine gel Intervention Drug with local anaesthetic	Drug: Diclofenac suppository plus lidocaine gel; Other Names: Voltral suppository ; Drug: Lidocaine gel only
Other: Lidocaine gel only Used as local aneaethetic as a part of institutional prostate biopsy protocol	Drug: Lidocaine gel only

Outcome Measures

Primary Outcome Measures

1. Pain on visual analog score [Two hours]

Secondary Outcome Measures

1. Adverse effects of diclofenac suppository [two hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 51 Years to 70 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aga Khan University Hospital	Karachi	Sindh	Pakistan	3500

Sponsors and Collaborators

• Aga Khan University

Investigators

• Principal Investigator: Naveed Haroon, MBBS, Aga Khan University

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.

• Responsible Party: Naveed Haroon, Resident, Aga Khan University
• ClinicalTrials.gov Identifier: NCT01939743
• Other Study ID Numbers: 11GS009SUR
• First Posted: Sep 11, 2013
• Last Update Posted: Sep 11, 2013
• Last Verified: Sep 1, 2013

• Additional relevant MeSH terms: Prostatic Neoplasms; Diclofenac; Lidocaine

Study Results

No Results Posted as of Sep 11, 2013