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

NCT06661902 | Completed Phase 1 FDA Drug

• 3 other identifiers: RG1125023STUDY00021446NCI-2024-10011
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Pain of Local Anesthetic Injection

  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 Outcomes (3)

• Pain of the Prostate Biopsy

  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

  Within 10 minutes of completing the prostate biopsy, and on post-operative day 1

• Incidence of adverse events

  Post-operative day 1

Study Arms (2)

Arm A (lidocaine)

ACTIVE COMPARATOR

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

Drug: Lidocaine; Procedure: Biopsy of Prostate; Other: Questionnaire Administration

Arm B (buffered lidocaine)

EXPERIMENTAL

Patients receive buffered lidocaine via injection during SOC prostate biopsy on study. (1% Lidocaine + 8.4% Sodium Bicarbonate, in a 3:1 ratio)

Drug: Buffered Lidocaine (1% Lidocaine + 8.4% Sodium Bicarbonate, in a 3:1 ratio); Procedure: Biopsy of Prostate; Other: Questionnaire Administration

Interventions

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

Given via injection

Arm B (buffered lidocaine)

Biopsy of Prostate PROCEDURE

Undergo SOC prostate biopsy

Also known as: Prostate Biopsy

Arm A (lidocaine); Arm B (buffered lidocaine)

Questionnaire Administration OTHER

Ancillary studies

Arm A (lidocaine); Arm B (buffered lidocaine)

Lidocaine DRUG

Given via injection

Arm A (lidocaine)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of signed and dated informed consent form
• 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
• core biopsy or \> 12cores
• Biopsy naïve or prior biopsy

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Lidocaine; Sodium Bicarbonate

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Bicarbonates; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Inorganic Chemicals; Sodium Compounds

Study Officials

• Alexander Zhu, DO

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The Investigational Drug Services team will be unblinded to the patient's randomization status. During statistical analysis of the data, the statistician will be concealed to the randomization allocation.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2024
• First Posted: October 28, 2024
• Study Start: January 9, 2025
• Primary Completion: January 27, 2026
• Study Completion: January 27, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)