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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
William Beaumont Hospitals
ClinicalTrials.gov Identifier:
NCT00441532
First received: February 28, 2007
Last updated: November 22, 2011
Last verified: October 2010
  Purpose

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.


Condition Intervention
Prostate Cancer
Drug: Lidocaine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Double-Blind Randomized Study On Lidocaine Vs. Placebo Pain Control During Transrectal Ultrasound Guided Prostate Biopsy

Resource links provided by NLM:


Further study details as provided by William Beaumont Hospitals:

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

Secondary Outcome Measures:
  • To determine if patients feel that they could tolerate such a procedure with no anesthesia

Estimated Enrollment: 50
Study Start Date: August 2005
Study Completion Date: August 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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 biopsy.
  3. Allergy to Lidocaine
  4. Patients requiring additional anesthesia (e.g. anxiolytics)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00441532

Locations
United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
Sponsors and Collaborators
William Beaumont Hospitals
Investigators
Principal Investigator: Ananias Diokno, M.D. William Beaumont Hospitals
  More Information

No publications provided

Responsible Party: William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT00441532     History of Changes
Other Study ID Numbers: 2005-117
Study First Received: February 28, 2007
Last Updated: November 22, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by William Beaumont Hospitals:
prostate

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 19, 2014