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

Phase 1

Recruiting

• Conditions: Prostate Cancer
• Interventions: Drug: Lidocaine; Procedure: Biopsy of Prostate; Other: Questionnaire Administration

• Registration Number: NCT06661902
• Lead Sponsor: University of Washington

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.

Study Timeline

• Study First Submitted: 2024-10-25
• Study First Submitted QC: 2024-10-25
• Study First Posted: 2024-10-28
• Status Verified: 2025-01
• Study Start: 2025-01-09
• Last Update Submitted: 2025-01-30
• Last Update Posted: 2025-02-03
• Primary Completion: 2026-02
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 300

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A (lidocaine)	Lidocaine	Patients receive SOC lidocaine via injection during SOC prostate biopsy on study.
Arm A (lidocaine)	Biopsy of Prostate	Patients receive SOC lidocaine via injection during SOC prostate biopsy on study.
Arm A (lidocaine)	Questionnaire Administration	Patients receive SOC lidocaine via injection during SOC prostate biopsy on study.
Arm B (buffered lidocaine)	Biopsy of Prostate	Patients receive buffered lidocaine via injection during SOC prostate biopsy on study. (1% Lidocaine + 8.4% Sodium Bicarbonate, in a 3:1 ratio)
Arm B (buffered lidocaine)	Questionnaire Administration	Patients receive buffered lidocaine via injection during SOC prostate biopsy on study. (1% Lidocaine + 8.4% Sodium Bicarbonate, in a 3:1 ratio)

Primary Outcome Measures

Name	Time	Method
Pain of Local Anesthetic Injection	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 Outcome Measures

Name	Time	Method
Pain of the Prostate Biopsy	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 \[worst pain\]).
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	Assessed by a questionnaire (Visual Analogue Scale, 0 \[least likely\] to 10 \[most likely\])
Incidence of adverse events	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.

Trial Locations

Locations (1)

Fred Hutch/University of Washington Cancer Consortium; 🇺🇸 Seattle, Washington, United States