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

NCT ID: NCT00441532

Last Updated: 2011-11-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-08-31
• Study Completion Date: 2006-08-31

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.

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

Keywords

prostate

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Lidocaine

Intervention Type: DRUG

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

William Beaumont Hospitals

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ananias Diokno, M.D.

Role: PRINCIPAL_INVESTIGATOR

William Beaumont Hospitals

Locations

William Beaumont Hospital

Royal Oak, Michigan, United States

Countries

United States

Other Identifiers

2005-117

Identifier Type: -

Identifier Source: org_study_id