Clinical trial NCT06661902: Buffered Lidocaine for Reducing Pain in Patients Undergoing Prostate Biopsy, BURN Trial
Official title: BURN Study: Buffered Lidocaine in Reducing Pain From Prostate Biopsy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Prostate Cancer
Keywords: prostate cancer
prostate biopsy
transperineal biopsy
transrectal biopsy
MRI fusion biopsy
buffered lidocaine
sodium bicarbonate
Local anesthesia
lidocaine
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2024-10-28
Enrollment: 300
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Pain of Local Anesthetic Injection
timeFrame: Within 20 seconds of completing the injection of all local anesthetic
Secondary outcomes:
measure: Pain of the Prostate Biopsy
timeFrame: Within 10 minutes of completing the prostate biopsy, and on post-operative day 1
measure: Willingness to perform another prostate biopsy in the future, if medically necessary
timeFrame: Within 10 minutes of completing the prostate biopsy, and on post-operative day 1
measure: Incidence of adverse events
timeFrame: Post-operative day 1
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Alexander Zhu, DO
role: PRINCIPAL_INVESTIGATOR
References: