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.|
|ClinicalTrials.gov Identifier: NCT00422708|
Recruitment Status : Completed
First Posted : January 17, 2007
Last Update Posted : January 20, 2010
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||243 participants|
|Intervention Model:||Parallel Assignment|
|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|
- Pain contol
- Changes to voiding function
- Changes to bowel function
- Changes to sexual function
- Impact on surgical treatment
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 ClinicalTrials.gov identifier (NCT number): NCT00422708
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Richard A. Ashley, M.D.||Mayo Clinic|