Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-26 @ 2:47 AM
Study NCT ID:
NCT06661902
Status:
RECRUITING
Last Update Posted:
2025-08-03
First Post:
2024-10-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Buffered Lidocaine for Reducing Pain in Patients Undergoing Prostate Biopsy, BURN Trial
Sponsor:
University of Washington
Organization:
Study Overview
Official Title:
BURN Study: Buffered Lidocaine in Reducing Pain From Prostate Biopsy
Status:
RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BURN
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: