RECRUITING

Buffered Lidocaine for Reducing Pain in Patients Undergoing Prostate Biopsy, BURN Trial

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This phase I/II trial examines if buffered lidocaine reduces the pain that patients may experience during prostate biopsy. Prostate biopsies are typically performed awake, in the office, with only local anesthetic. As a result, many patients note considerable pain during these procedures. Local anesthetics such as lidocaine are typically acidic, which is thought to cause pain and burning during infiltration (injection). As a result, buffered local anesthetic has become the standard of care (SOC) in multiple specialties using awake local anesthetic. However, it has not been explored during prostate biopsies. Adminstering buffered lidocaine may reduce pain in patients undergoing prostate biopsy.

Official Title

BURN Study: Buffered Lidocaine in Reducing Pain From Prostate Biopsy

Quick Facts

Study Start:2025-01-09
Study Completion:2026-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06661902

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Provision of signed and dated informed consent form
  2. * 18 years old or older
  3. * Patients with prostates
  4. * Those with and without a prior diagnosis of prostate cancer
  5. * Recommended to undergo a prostate biopsy in the urology clinic. Only patients that have been scheduled for a biopsy (for clinical purposes) will be enrolled. May include all of the following types of prostate biopsies:
  6. * Transperineal or transrectal
  7. * Systematic or targeted/fusion biopsy
  8. * 12 core biopsy or \> 12cores
  9. * Biopsy naïve or prior biopsy
  1. * Anorectal pathology precluding placement of a transrectal ultrasound
  2. * Diagnosis of chronic prostatitis, interstitial cystitis, pelvic pain syndrome
  3. * Concomitant chronic pain condition
  4. * Neurological condition affecting pain or sensorium (ex. spinal cord injury, stroke, multiple sclerosis, etc.)
  5. * Prostate biopsy performed with any anesthesia other than local anesthetic (monitored anesthesia care, general anesthesia)
  6. * Prostate biopsy completed in the operating room
  7. * Patients who ultimately require additional local anesthetic beyond what is allotted in the study intervention
  8. * Patients taking anxiolytics in the 6-hours prior to the biopsy
  9. * Those with a known hypersensitivity, allergic reaction, or contraindication to using sodium bicarbonate. This includes patients who are receiving diuretics known to produce a hypochloremic alkalosis

Contacts and Locations

Study Contact

Alexander Zhu, DO
CONTACT
949-633-6048
azhu5@uw.edu

Principal Investigator

Alexander Zhu, DO
PRINCIPAL_INVESTIGATOR
Fred Hutch/University of Washington Cancer Consortium

Study Locations (Sites)

Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98195
United States

Collaborators and Investigators

Sponsor: University of Washington

  • Alexander Zhu, DO, PRINCIPAL_INVESTIGATOR, Fred Hutch/University of Washington Cancer Consortium

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-09
Study Completion Date2026-02

Study Record Updates

Study Start Date2025-01-09
Study Completion Date2026-02

Terms related to this study

Keywords Provided by Researchers

  • prostate cancer
  • prostate biopsy
  • transperineal biopsy
  • transrectal biopsy
  • MRI fusion biopsy
  • buffered lidocaine
  • sodium bicarbonate
  • Local anesthesia
  • lidocaine

Additional Relevant MeSH Terms

  • Prostate Cancer