Local Anesthesia for Prostate Biopsy

NCT00422708 | Completed Phase 4

• 1 other identifier: 1608-05
• Study Type: interventional
• Target: 243
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Pain contol

Secondary Outcomes (4)

• Changes to voiding function

• Changes to bowel function

• Changes to sexual function

• Impact on surgical treatment

Interventions

Local anesthesia PROCEDURE

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• Ashley RA, Inman BA, Routh JC, Krambeck AE, Siddiqui SA, Mynderse LA, Gettman MT, Blute ML. Preventing pain during office biopsy of the prostate: a single center, prospective, double-blind, 3-arm, parallel group, randomized clinical trial. Cancer. 2007 Oct 15;110(8):1708-14. doi: 10.1002/cncr.22973.

  PMID: 17724727 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Anesthesia, Local

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• Richard A. Ashley, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 15, 2007
• First Posted: January 17, 2007
• Study Start: June 1, 2006
• Primary Completion: June 1, 2006
• Study Completion: June 1, 2008
• Last Updated: January 20, 2010

Record last verified: 2010-01

Locations

US (1)