Buffered Lidocaine for Reducing Pain in Patients Undergoing Prostate Biopsy, BURN Trial
Status
RECRUITING
Phase
PHASE1, PHASE2
Age
≥ 18 Years
Enrollments
300Conditions
Prostate CancerDrugs
Buffered Lidocaine (1% Lidocaine + 8.4% Sodium Bicarbonate, in a 3:1 ratio), LidocaineSummary
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.
Locations
1 location Found with status Recruiting
Status
- RECRUITING
Contact Person
- Alexander Zhu, DO
- 949-633-6048
- [email protected]
Principal Investigator
- Alexander Zhu, DO
Eligibility Criteria
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 Plan
Arm A (lidocaine)
ACTIVE_COMPARATOR
Patients receive SOC lidocaine via injection during SOC prostate biopsy on study.
DRUG:
LidocaineDescription:
Given via injectionPROCEDURE:
Biopsy of ProstateDescription:
Undergo SOC prostate biopsyOTHER:
Questionnaire AdministrationDescription:
Ancillary studies
Arm B (buffered lidocaine)
EXPERIMENTAL
Patients receive buffered lidocaine via injection during SOC prostate biopsy on study. (1% Lidocaine + 8.4% Sodium Bicarbonate, in a 3:1 ratio)
DRUG:
Buffered Lidocaine (1% Lidocaine + 8.4% Sodium Bicarbonate, in a 3:1 ratio)Description:
Given via injectionPROCEDURE:
Biopsy of ProstateDescription:
Undergo SOC prostate biopsyOTHER:
Questionnaire AdministrationDescription:
Ancillary studies
Outcome Measures
Primary Outcome Measures
Pain of Local Anesthetic Injection
Secondary Outcome Measures
Pain of the Prostate Biopsy
Willingness to perform another prostate biopsy in the future, if medically necessary
Incidence of adverse events
Timeline
Last Updated
February 3, 2025Start Date
October 28, 2024Today
May 12, 2025Completion Date ( Estimated )
February 1, 2026
Sponsors of this trial
Lead Sponsor
University of Washington
RECRUITING 
≥ 18 Years