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

NCT ID: NCT06661902

Last Updated: 2026-01-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 350 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-09
• Study Completion Date: 2026-01-31

Brief Summary

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.

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

Arm A (lidocaine)

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

Group Type: ACTIVE_COMPARATOR

Lidocaine

Intervention Type: DRUG

Given via injection

Biopsy of Prostate

Intervention Type: PROCEDURE

Undergo SOC prostate biopsy

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

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)

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

Given via injection

Biopsy of Prostate

Intervention Type: PROCEDURE

Undergo SOC prostate biopsy

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Interventions

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

Given via injection

Intervention Type: DRUG

Lidocaine

Given via injection

Intervention Type: DRUG

Biopsy of Prostate

Undergo SOC prostate biopsy

Intervention Type: PROCEDURE

Questionnaire Administration

Ancillary studies

Intervention Type: OTHER

Other Intervention Names

Prostate Biopsy

Eligibility Criteria

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

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

Sponsors

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alexander Zhu, DO

Role: PRINCIPAL_INVESTIGATOR

Fred Hutch/University of Washington Cancer Consortium

Locations

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Alexander Zhu, DO

Role: CONTACT

azhu5@uw.edu

949-633-6048

Facility Contacts

Alexander Zhu, DO

Role: primary

azhu5@uw.edu

949-633-6048

Other Identifiers

STUDY00021446

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-2024-10011

Identifier Type: REGISTRY

Identifier Source: secondary_id

RG1125023

Identifier Type: -

Identifier Source: org_study_id