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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01939743
Recruitment Status : Completed
First Posted : September 11, 2013
Last Update Posted : September 11, 2013
Information provided by (Responsible Party):
Naveed Haroon, 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.

Condition or disease Intervention/treatment Phase
Carcinoma Prostate Drug: Diclofenac suppository plus lidocaine gel Drug: Lidocaine gel only Phase 2

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Study Type : Interventional  (Clinical Trial)
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 : October 2011
Actual Primary Completion Date : September 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arm Intervention/treatment
Experimental: diclofenac suppository plus lidocaine gel
Intervention Drug with local anaesthetic
Drug: Diclofenac suppository plus lidocaine gel
Other Name: Voltral suppository

Drug: Lidocaine gel only
Lidocaine gel only
Used as local aneaethetic as a part of institutional prostate biopsy protocol
Drug: Lidocaine gel only

Primary Outcome Measures :
  1. Pain on visual analog score [ Time Frame: Two hours ]

Secondary Outcome Measures :
  1. Adverse effects of diclofenac suppository [ Time Frame: two hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   51 Years to 70 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01939743

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Aga Khan University Hospital
Karachi, Sindh, Pakistan, 3500
Sponsors and Collaborators
Aga Khan University
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Principal Investigator: Naveed Haroon, MBBS Aga Khan University
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Responsible Party: Naveed Haroon, Resident, Aga Khan University Identifier: NCT01939743    
Other Study ID Numbers: 11GS009SUR
First Posted: September 11, 2013    Key Record Dates
Last Update Posted: September 11, 2013
Last Verified: September 2013
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors