Buffered lidocaine to reduce pain during prostate biopsy
BURN Study: Buffered Lidocaine in Reducing Pain From Prostate Biopsy
This study is testing if a special form of lidocaine can make prostate biopsy patients feel less pain compared to the usual lidocaine.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | University of Washington Academic / other |
| Locations | 1 site (Seattle, Washington) |
| Trial ID | NCT06661902 on ClinicalTrials.gov |
What this trial studies
This phase I/II trial investigates whether buffered lidocaine can alleviate pain experienced by patients undergoing prostate biopsies. Typically, these procedures are performed with local anesthetic, which can cause significant discomfort. The study involves randomizing patients to receive either standard lidocaine or buffered lidocaine during their biopsy. The goal is to determine if the buffered formulation, which is less acidic, results in a more comfortable experience for patients. Participants will be followed up 1-2 days post-biopsy to assess pain levels.
Who should consider this trial
Good fit: Ideal candidates include adult males scheduled for a prostate biopsy, regardless of prior biopsy history or prostate cancer diagnosis.
Not a fit: Patients with certain anorectal pathologies, chronic pain conditions, or those requiring anesthesia beyond local anesthetic may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce pain during prostate biopsies, improving patient comfort and experience.
How similar studies have performed: Other studies have shown success with buffered local anesthetics in various procedures, suggesting potential for similar benefits in prostate biopsies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Seattle, Washington
- Fred Hutch/University of Washington Cancer Consortium — Seattle, Washington, United States (Recruiting)
Study contacts
- Principal investigator: Alexander Zhu, DO — Fred Hutch/University of Washington Cancer Consortium
- Study coordinator: Alexander Zhu, DO
- Email: azhu5@uw.edu
- Phone: 949-633-6048
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.