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

University of Washington

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Prostate Cancer

Treatments: Drug: Buffered Lidocaine (1% Lidocaine + 8.4% Sodium Bicarbonate, in a 3:1 ratio); Drug: Lidocaine; Other: Questionnaire Administration; Procedure: Biopsy of Prostate

Study type: Interventional

Funder types: Other

Identifiers

NCT06661902

NCI-2024-10011 (Registry Identifier)

RG1125023

STUDY00021446

Details and patient eligibility

About

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.

Full 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.

Enrollment: 350 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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350 participants in 2 patient groups

Arm A (lidocaine)

Active Comparator group

Description:

Patients receive SOC lidocaine via injection during SOC prostate biopsy on study.

Treatment:

Procedure: Biopsy of Prostate

Other: Questionnaire Administration

Drug: Lidocaine

Arm B (buffered lidocaine)

Experimental group

Description:

Patients receive buffered lidocaine via injection during SOC prostate biopsy on study. (1% Lidocaine + 8.4% Sodium Bicarbonate, in a 3:1 ratio)

Treatment:

Procedure: Biopsy of Prostate

Other: Questionnaire Administration

Drug: Buffered Lidocaine (1% Lidocaine + 8.4% Sodium Bicarbonate, in a 3:1 ratio)