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| Sponsor: | Mayo Clinic |
|---|---|
| Information provided by: | Mayo Clinic |
| ClinicalTrials.gov Identifier: | NCT00422708 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Procedure: Local anesthesia |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Treatment |
| Official Title: | Local Anesthesia for Prostate Biopsy: Effects on Pain Control, Quality of Life, and Surgical Intervention |
| Enrollment: | 243 |
| Study Start Date: | June 2006 |
| Study Completion Date: | June 2008 |
| Primary Completion Date: | June 2006 (Final data collection date for primary outcome measure) |
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders 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:
The following exclusion criteria must be in place to prevent complications and interference with data interpretation:
Contacts and Locations
More Information
| ClinicalTrials.gov Identifier: | NCT00422708 History of Changes |
| Other Study ID Numbers: | 1608-05 |
| Study First Received: | January 15, 2007 |
| Last Updated: | January 19, 2010 |
| Health Authority: | United States: Institutional Review Board |
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Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases |
Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses |