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Trial Title:
BURN Study: Buffered Lidocaine in Reducing Pain from Prostate Biopsy
NCT ID:
NCT06661902
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Lidocaine
Conditions: Keywords:
prostate cancer
prostate biopsy
transperineal biopsy
transrectal biopsy
MRI fusion biopsy
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
Buffered Lidocaine (1% Lidocaine + 8.4% Sodium Bicarbonate, in a 3:1 ratio)
Description:
Patients scheduled for prostate biopsy will be approached for the study. Following
enrollment, participants will complete three questionnaires that assess their baseline
pain and anxiety scores.
Patients will then be randomized to one of two arms for their local anesthetic: (A) 1%
Lidocaine or (B) Buffered Lidocaine. The patient and urologist will both be blinded to
the contents of the local anesthetic.
During the procedure, local anesthetic will be administered in the standard fashion.
Patients will then complete a series of questionnaires asking about the pain associated
with the local anesthetic and prostate biopsy as a whole. Complications will be assessed.
Arm group label:
1% Lidocaine
Intervention type:
Drug
Intervention name:
1% Lidocaine HCL
Description:
Patients scheduled for prostate biopsy will be approached for the study. Following
enrollment, participants will complete three questionnaires that assess their baseline
pain and anxiety scores.
Patients will then be randomized to one of two arms for their local anesthetic: (A) 1%
Lidocaine or (B) Buffered Lidocaine. The patient and urologist will both be blinded to
the contents of the local anesthetic.
During the procedure, local anesthetic will be administered in the standard fashion.
Patients will then complete a series of questionnaires asking about the pain associated
with the local anesthetic and prostate biopsy as a whole. Complications will be assessed.
Arm group label:
Buffered Lidocaine
Summary:
The goal of this clinical trial is to determine if Buffered Lidocaine may reduce the pain
that patients experience during a prostate biopsy. It will also learn about the safety of
Buffered Lidocaine. The main question it aims to answer is:
1) Does Buffered Lidocaine (1% Lidocaine + 8.4% Sodium Bicarbonate, in a 3:1 ratio)
reduce the pain of local anesthetic injection during prostate biopsy, as compared to
1% Lidocaine
Researchers will compare the pain that patients report during a prostate biopsy after
receiving either (A) Buffered Lidocaine or (B) 1% Lidocaine for their local anesthetic.
Participants will:
- Prior to the biopsy, complete a series of questionnaires determining their baseline
pain and anxiety scores
- Undergo a prostate biopsy, with either Buffered Lidocaine or 1% Lidocaine as their
local anesthetic
- Complete a series of questionnaires assessing the pain they experienced during and
after the procedure, as well as any complications they may have experienced
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Provision of signed and dated informed consent form
2. 18 years old or older
3. Biological males
4. Those with and without a prior diagnosis of prostate cancer
5. Recommended to undergo a prostate biopsy in the urology clinic. May include all of
the following types of prostate biopsies:
1. Transperineal or Transrectal
2. Systematic or Targeted/Fusion Biopsy
3. 12 core or >12cores
4. Biopsy naïve or Prior biopsies
Exclusion Criteria:
1. Anorectal pathology precluding placement of a transrectal ultrasound
2. Diagnosis of chronic prostatitis, interstitial cystitis, pelvic pain syndrome
3. Concomitant chronic pain condition
4. Neurological condition affecting pain or sensorium (ex. spinal cord injury, stroke,
multiple sclerosis, etc)
5. Prostate biopsy performed with any anesthesia other than local anesthetic (monitored
anesthesia care, general anesthesia)
6. Prostate biopsy completed in the operating room
7. Patients who ultimately require additional local anesthetic beyond what is allotted
in the study intervention
8. Patients taking anxiolytics in the 6-hours prior to the biopsy
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Washington
Address:
City:
Seattle
Zip:
98195
Country:
United States
Contact:
Last name:
Alex Zhu, DO
Phone:
9496336048
Email:
azhu5@uw.edu
Start date:
February 2025
Completion date:
February 2026
Lead sponsor:
Agency:
University of Washington
Agency class:
Other
Source:
University of Washington
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06661902
