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

Phase 2

Completed

• Conditions: Carcinoma Prostate
• Interventions: Drug: Diclofenac suppository plus lidocaine gel; Drug: Lidocaine gel only

• Registration Number: NCT01939743
• Lead Sponsor: Aga Khan University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Primary Completion: 2012-09
• Study Completion: 2012-10
• Study First Submitted: 2013-04-01
• Status Verified: 2013-09
• Study First Submitted QC: 2013-09-07
• Last Update Submitted: 2013-09-07
• Study First Posted: 2013-09-11
• Last Update Posted: 2013-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
diclofenac suppository plus lidocaine gel	Diclofenac suppository plus lidocaine gel	Intervention Drug with local anaesthetic
diclofenac suppository plus lidocaine gel	Lidocaine gel only	Intervention Drug with local anaesthetic
Lidocaine gel only	Lidocaine gel only	Used as local aneaethetic as a part of institutional prostate biopsy protocol

Primary Outcome Measures

Name	Time	Method
Pain on visual analog score	Two hours

Secondary Outcome Measures

Name	Time	Method
Adverse effects of diclofenac suppository	two hours

Trial Locations

Locations (1)

Aga Khan University Hospital; 🇵🇰 Karachi, Sindh, Pakistan