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NCT Number: NCT06661902

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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Buffered Lidocaine (1% Lidocaine + 8.4% Sodium Bicarbonate, in a 3:1 ratio)

Drug

Given via injection

Lidocaine

Drug

Given via injection

Biopsy of Prostate

Procedure

Undergo SOC prostate biopsy

Other names: Prostate Biopsy

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. 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]).

Secondary outcomes

  1. 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]).

  2. 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])

  3. 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.

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Registry information

Official study title

BURN Study: Buffered Lidocaine in Reducing Pain From Prostate Biopsy

Acronym: BURN

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 28, 2024
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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