Study On Lidocaine Vs. Placebo Pain Control During Transrectal Ultrasound Guided Prostate Biopsy
A Double-Blind Randomized Study On Lidocaine Vs. Placebo Pain Control During Transrectal Ultrasound Guided Prostate Biopsy
1 other identifier
interventional
50
1 country
1
Brief Summary
Patients at risk for having prostate cancer usually undergo a biopsy of their prostate. This is most often done in the private urology office. Recent studies have suggested that injection of local anesthesia (lidocaine) near the nerves of the prostate will improve pain sensation during the biopsy procedure. Local anesthesia can be given through a separate needle through the rectal probe just prior to biopsy. However, many urologists to date perform their biopsies without anesthesia. Some claim that the needle used for anesthesia causes pain itself. Others claim that the pain is so minimal that the additional use of lidocaine (and extra time) is not necessary. We plan to reexamine the use of lidocaine and perform the first study where each patient will receive lidocaine and placebo on separate sides of their prostate.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable prostate-cancer
Started Aug 2005
Shorter than P25 for not_applicable prostate-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2006
CompletedFirst Submitted
Initial submission to the registry
February 28, 2007
CompletedFirst Posted
Study publicly available on registry
March 1, 2007
CompletedNovember 23, 2011
October 1, 2010
1 year
February 28, 2007
November 22, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To determine if patients experience a significant difference in pain on the side of their prostate that had local anesthesia.
Secondary Outcomes (1)
To determine if patients feel that they could tolerate such a procedure with no anesthesia
Interventions
Eligibility Criteria
You may qualify if:
- Patients who are undergoing prostate ultrasound-guided biopsy from the practice of Drs. Diokno and Hollander.
- Patients must speak English.
- Patients must sign consent form.
You may not qualify if:
- Patients having received prior radiation to the pelvic area.
- Patients with any neurologic disorder that may interfere with pain sensation during biopsy.
- Allergy to Lidocaine
- Patients requiring additional anesthesia (e.g. anxiolytics)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
William Beaumont Hospital
Royal Oak, Michigan, 48073, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ananias Diokno, M.D.
Corewell Health East
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 28, 2007
First Posted
March 1, 2007
Study Start
August 1, 2005
Primary Completion
August 1, 2006
Study Completion
August 1, 2006
Last Updated
November 23, 2011
Record last verified: 2010-10