drugset / Trial / NCT06661902

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

NCT06661902

Phase 1/2 Completed 350 enrolled University of Washington
RandomizedParallel-groupQuadruple-blindSupportive care

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.

Timeline

Start
2025-01-09
Primary completion
2026-01-27
Completion
2026-01-27

Drugs

EvaluationDrugModalityDoseRoute
Subject Lidocaine Other / unclassified 1 % Other
Subject sodium bicarbonate Diagnostic / imaging agent 8.4 % Other

Indications