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

Launched by UNIVERSITY OF WASHINGTON · Oct 25, 2024

Keywords

ClinConnect Summary

The BURN Study is a clinical trial that aims to find out if a special type of local anesthetic called Buffered Lidocaine can help reduce the pain men feel during a prostate biopsy. This study will compare the pain levels experienced by participants who receive Buffered Lidocaine with those who receive regular Lidocaine. Researchers want to see if the buffered version, which includes a mix of lidocaine and sodium bicarbonate, makes the procedure more comfortable. The trial is looking for men aged 18 and older who need to have a prostate biopsy, whether they have been diagnosed with prostate cancer or not.

If you decide to participate, you will first fill out some questionnaires about your pain and anxiety levels. Then, during the biopsy, you will receive either Buffered Lidocaine or regular Lidocaine for pain relief. After the procedure, you will answer more questions about your experience and any complications. It's important to note that certain health conditions or medications may exclude you from participating. The study is currently recruiting, so if you are eligible, you can contribute to understanding how to improve comfort during prostate biopsies.

Gender

MALE

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