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A Double-Blind Randomized Study On Lidocaine Vs. Placebo Pain Control During Transrectal Ultrasound Guided Prostate Biopsy

18 Years
Not Enrolling
Prostate Cancer

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Trial Information

A Double-Blind Randomized Study On Lidocaine Vs. Placebo Pain Control During Transrectal Ultrasound Guided Prostate Biopsy

Patients at risk for having prostate cancer usually undergo a biopsy of their prostate. This
is most often done in the private urology office. A probe with an ultrasound is inserted
into the rectum of the patient and biopsies are taken with a spring-loaded needle. Most
urologists take four to six biopsies of each side of the prostate. Years ago, biopsies were
traditionally done without any anesthesia. Patients experienced some pain with each firing
of the spring-loaded needle, but this is generally tolerable. 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.

Patients will undergo the traditional prostate biopsy procedure. They will be in the urology
center at William Beaumont Hospital. Patients will lie on their side and an ultrasound probe
will be inserted into the rectum. The size of the prostate will be measured with the
ultrasound probe. A study coordinator will hand the physician a syringe containing either
2.5mL of lidocaine or saline (placebo). Neither the patient nor the physician will know
which solution the syringe contains. The 2.5mL of the first syringe will be injected in the
traditional area that local anesthesia is injected (periprostatic area) on the right side.
Next, the second syringe will be handed to the physician containing the opposite drug
(lidocaine or saline) and the physician will inject this on the left side. Four to six
biopsies will be taken on the right side, and the study coordinator will record patient pain
on a 1 to 10 scale after injection of the 2.5mL, and after each biopsy. Biopsies will then
be taken on the left side, and again, study coordinators will record results of patient pain
on a 1 to 10 scale. At the end of the procedure, patients will be given a questionnaire to
assess overall pain, tolerability of the procedure, and whether or not they could tell which
side of their prostate received the anesthesia.

Inclusion Criteria:

1. Patients who are undergoing prostate ultrasound-guided biopsy from the practice of
Drs. Diokno and Hollander.

2. Patients must speak English.

3. Patients must sign consent form.

Exclusion Criteria:

1. Patients having received prior radiation to the pelvic area.

2. Patients with any neurologic disorder that may interfere with pain sensation during

3. Allergy to Lidocaine

4. Patients requiring additional anesthesia (e.g. anxiolytics)

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

To determine if patients experience a significant difference in pain on the side of their prostate that had local anesthesia.

Principal Investigator

Ananias Diokno, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

William Beaumont Hospitals


United States: Institutional Review Board

Study ID:




Start Date:

August 2005

Completion Date:

August 2006

Related Keywords:

  • Prostate Cancer
  • prostate
  • Prostatic Neoplasms



William Beaumont Hospital Royal Oak, Michigan  48073