Buffered Lidocaine for Prostate Cancer Biopsy Pain (BURN Trial)

Phase 1 & 2

Waitlist Available

Led By Alexander Zhu, DO

Research Sponsored by University of Washington

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 years old or older

Biological males

Must not have

Neurological condition affecting pain or sensorium (ex. spinal cord injury, stroke, multiple sclerosis, etc)

Anorectal pathology precluding placement of a transrectal ultrasound

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 10 seconds of completing injection of all local anesthetic

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if Buffered Lidocaine can reduce pain during a prostate biopsy compared to regular Lidocaine. Participants will receive either Buffered Lidocaine or regular Lidocaine as a local

Who is the study for?

This trial is for men with prostate cancer who are scheduled to undergo a prostate biopsy. Participants must be willing to complete questionnaires about their pain and anxiety before and after the procedure. There's no specific exclusion criteria provided, but typically, patients with allergies to anesthetics or certain medical conditions may not qualify.

What is being tested?

The BURN Study is testing whether Buffered Lidocaine reduces pain during a prostate biopsy compared to standard 1% Lidocaine. Patients will receive one of these two local anesthetics at random and report their pain levels through questionnaires before and after the biopsy.

What are the potential side effects?

While specific side effects aren't listed, common reactions to lidocaine include temporary redness, swelling at the injection site, numbness beyond the target area, or in rare cases allergic reactions. Buffered solutions might reduce stinging on injection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am a biological male.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a neurological condition like spinal cord injury or MS.

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I cannot have a transrectal ultrasound due to anorectal issues.

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I have been diagnosed with chronic prostatitis, interstitial cystitis, or pelvic pain syndrome.

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My prostate biopsy was done in the operating room.

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My prostate biopsy was done under anesthesia that was more than just a local anesthetic.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 10 seconds of completing injection of all local anesthetic

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 10 seconds of completing injection of all local anesthetic

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 10 seconds of completing injection of all local anesthetic for reporting.