NCT06661902

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

BURN Study: Buffered Lidocaine in Reducing Pain From Prostate Biopsy

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 350 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Buffered Lidocaine (1% Lidocaine + 8.4% Sodium Bicarbonate, in a 3:1 ratio)	Given via injection
DRUG	Lidocaine	Given via injection
PROCEDURE	Biopsy of Prostate	Undergo SOC prostate biopsy
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2025-01-09
• Primary completion: 2026-01-27
• Completion: 2026-01-27
• First posted: 2024-10-28
• Last updated: 2026-02-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study