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Prostate CancerNCT00441532

Study On Lidocaine Vs. Placebo Pain Control During Transrectal Ultrasound Guided Prostate Biopsy

A study testing Lidocaine in people with Prostate Cancer, run by Corewell Health East at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Lidocaine
How many people
50 participants
Where
1 siteUnited States
Study dates
Aug 2005to Aug 2006
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

United States1 site
  • William Beaumont Hospital

    Royal Oak, Michigan, 48073

Other trials in United States

About this study

Official title: 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. 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.

Read the detailed description

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.

Conditions
Prostate Cancer
Being tested
Lidocaine
Keywords
prostate
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (1)
  1. To determine if patients feel that they could tolerate such a procedure with no anesthesia

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Mar 2007 (estimated)
  2. Study startAug 2005
  3. Primary completionAug 2006
  4. Study completionAug 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
50 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00441532
Sponsor's protocol ID
2005-117
Status last verified
Oct 2010
First submitted
28 Feb 2007
Last updated
23 Nov 2011
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Lidocaine in people with Prostate Cancer, run by Corewell Health East at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To determine if patients experience a significant difference in pain on the side of their prostate that had local anesthesia.. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2011; AzTrials last refreshed its copy on 7 Nov 2026.

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