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

February 11, 2026 updated by: University of Washington

BURN Study: Buffered Lidocaine in Reducing Pain From Prostate Biopsy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients receive SOC lidocaine via injection during SOC prostate biopsy on study.

ARM B: Patients receive buffered lidocaine via injection during SOC prostate biopsy on study.

After completion of study intervention, patients are followed up 1-2 days post-biopsy.

Study Type

Interventional

Enrollment (Actual)

350

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Anorectal pathology precluding placement of a transrectal ultrasound
  • Diagnosis of chronic prostatitis, interstitial cystitis, pelvic pain syndrome
  • Concomitant chronic pain condition
  • Neurological condition affecting pain or sensorium (ex. spinal cord injury, stroke, multiple sclerosis, etc.)
  • 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
  • Patients taking anxiolytics in the 6-hours prior to the biopsy
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm A (lidocaine)
Patients receive SOC lidocaine via injection during SOC prostate biopsy on study.
Other: Questionnaire Administration
Ancillary studies
Drug: Lidocaine
Given via injection
Procedure: Biopsy of Prostate
Undergo SOC prostate biopsy
Other Names:
  • Prostate Biopsy
Experimental: Arm B (buffered lidocaine)
Patients receive buffered lidocaine via injection during SOC prostate biopsy on study. (1% Lidocaine + 8.4% Sodium Bicarbonate, in a 3:1 ratio)
Other: Questionnaire Administration
Ancillary studies
Procedure: Biopsy of Prostate
Undergo SOC prostate biopsy
Other Names:
  • Prostate Biopsy
Drug: Buffered Lidocaine (1% Lidocaine + 8.4% Sodium Bicarbonate, in a 3:1 ratio)
Given via injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain of Local Anesthetic Injection
Time Frame: Within 20 seconds of completing the injection of all local anesthetic
Pain associated with the injection of local anesthetic, assessed by a written questionnaire (Visual Analogue Scale, 0 [least] to 10 [worst pain]).
Within 20 seconds of completing the injection of all local anesthetic

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain of the Prostate Biopsy
Time Frame: Within 10 minutes of completing the prostate biopsy, and on post-operative day 1
Pain associated with the biopsies of the prostate, assessed by a questionnaire (Visual Analogue Scale, 0 [least] to 10 [worst pain]).
Within 10 minutes of completing the prostate biopsy, and on post-operative day 1
Willingness to perform another prostate biopsy in the future, if medically necessary
Time Frame: Within 10 minutes of completing the prostate biopsy, and on post-operative day 1
Assessed by a questionnaire (Visual Analogue Scale, 0 [least likely] to 10 [most likely])
Within 10 minutes of completing the prostate biopsy, and on post-operative day 1
Incidence of adverse events
Time Frame: Post-operative day 1
Will be assessed by patient self-report using an electronic written questionnaire. Will be assessed for inability to urinate, bleeding, allergic reaction, fever, or fatigue, or significant chills, or nausea/vomiting.
Post-operative day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Investigators

  • Principal Investigator: Alexander Zhu, DO, 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 Major Dates

Study Start (Actual)

January 9, 2025

Primary Completion (Actual)

January 27, 2026

Study Completion (Actual)

January 27, 2026

Study Registration Dates

First Submitted

October 25, 2024

First Submitted That Met QC Criteria

October 25, 2024

First Posted (Actual)

October 28, 2024

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 11, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RG1125023
  • STUDY00021446 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)
  • NCI-2024-10011 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This is a single center, investigator initiated trial.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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