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Local Anesthesia for Prostate Biopsy

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: NCT00422708
Recruitment Status : Completed
First Posted : January 17, 2007
Last Update Posted : January 20, 2010
Information provided by:
Mayo Clinic

Brief Summary:

Title: Local anesthesia for office biopsy of the prostate: effects on pain control, quality of life and surgical intervention.

Introduction: Local anesthetic should be administered prior to transrectal needle biopsy of the prostate to control pain in the office setting. Various centers have injected anesthetic in different regions in and around the prostate prior to biopsy. Patient experience with each technique has varied. We would like to determine which procedure provides the best pain control. In addition, we would like to know if the anesthetic placement has any effect on urinary patterns, bowel habits, and sexual function. Furthermore, for those patients found to have cancer and elect surgical treatment, we plan to evaluate if the anesthetic had an impact on surgical dissection of their prostate.

Methods: The investigators plan to identify those patients who require prostate biopsy for diagnosis. Each patient will be randomly assigned to a different anesthetic injection group. During the biopsy protocol, our nurse will monitor the patient?s pain level according to the visual analog score. The patient will complete a pre-biopsy questionnaire and two post-biopsy questionnaires administered at 1 and 4 weeks after biopsy. He will receive results of the prostate biopsy pathology report within 48 hours by calling his primary referral service.

Condition or disease Intervention/treatment Phase
Prostate Cancer Procedure: Local anesthesia Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 243 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Local Anesthesia for Prostate Biopsy: Effects on Pain Control, Quality of Life, and Surgical Intervention
Study Start Date : June 2006
Actual Primary Completion Date : June 2006
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Primary Outcome Measures :
  1. Pain contol

Secondary Outcome Measures :
  1. Changes to voiding function
  2. Changes to bowel function
  3. Changes to sexual function
  4. Impact on surgical treatment

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Our study will not exclude patients based on age or race. Any male patient seen in our clinic with the following conditions that warrant and consent to transrectal needle biopsy of the prostate would be recruited for this study:

  1. Elevated serum PSA
  2. Hypoechoic nodule incidentally discovered on transrectal ultrasound for other purposes
  3. Abnormal digital rectal exam (DRE)

The following exclusion criteria must be in place to prevent complications and interference with data interpretation:

  1. Patients taking narcotics on a routine basis
  2. Patients on Coumadin therapy
  3. Patients with ano-rectal disease
  4. Patients with history of prostatitis, pelvic pain, pelvic floor tension myalgia, or other pain syndromes
  5. Patients with active prostate abscess or urinary tract infection
  6. Patients with allergy to local anesthetic

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): NCT00422708

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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
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Principal Investigator: Richard A. Ashley, M.D. Mayo Clinic

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00422708    
Other Study ID Numbers: 1608-05
First Posted: January 17, 2007    Key Record Dates
Last Update Posted: January 20, 2010
Last Verified: January 2010
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Central Nervous System Depressants
Physiological Effects of Drugs