NCT06661902CompletedPhase 1/2
Buffered Lidocaine for Reducing Pain in Patients Undergoing Prostate Biopsy, BURN Trial
BURN Study: Buffered Lidocaine in Reducing Pain From Prostate Biopsy
Source: ClinicalTrials.gov · Last updated 17 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 350 (actual)
- First submitted
- 25 Oct 2024
- Start date
- 9 Jan 2025
- Primary completion date
- 27 Jan 2026
- Lead sponsor
- University of Washington
- Diseases
- Prostate cancer
- NCT number
- NCT06661902
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 350
- From 9 Jan 2025 to the primary completion date, 27 Jan 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant chronic pain condition
- Patients taking anxiolytics in the 6-hours prior to the biopsy
Other illness
- Diagnosis of chronic prostatitis, interstitial cystitis, pelvic pain syndrome
- Neurological condition affecting pain or sensorium (ex. spinal cord injury, stroke, multiple sclerosis, etc.)
Lab values
- 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
Other
- Anorectal pathology precluding placement of a transrectal ultrasound
- Prostate biopsy performed with any anesthesia other than local anesthetic (monitored anesthesia care, general anesthesia)
- Prostate biopsy completed in the operating room
- Patients who ultimately require additional local anesthetic beyond what is allotted in the study intervention
Who the study is looking for
- Provision of signed and dated informed consent form
- 18 years old or older
- Patients with prostates
- Those with and without a prior diagnosis of prostate cancer
- 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:
- Transperineal or transrectal
- Systematic or targeted/fusion biopsy
- 12 core biopsy or \> 12cores
- Biopsy naïve or prior biopsy
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fred Hutch/University of Washington Cancer Consortium Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.