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Buffered lidocaine eases prostate biopsy pain in new study

NCT ID NCT06661902

Symptom relief Sponsor: University of Washington Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether buffered lidocaine (lidocaine mixed with baking soda) reduces pain during prostate biopsy. 350 men undergoing a prostate biopsy received either buffered or standard lidocaine. Researchers measured pain from the numbing injection and from the biopsy itself using a 0-10 scale.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
buffered lidocaine (lidocaine mixed with sodium bicarbonate)
What this could lead to
If it works, this could make prostate biopsies less painful for many men.
What could go wrong
This is an early-phase study (phase I/II) with 350 participants. The results may not apply to all biopsy types or settings, and the pain reduction might be small.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

350 people

The number who actually took part.

Started

Jan 2025

Finished

Jan 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

prostate cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Prostate cancer

Contacts and locations

Locations

  • Fred Hutch/University of Washington Cancer Consortium

    Seattle, Washington, 98195, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.