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

Phase 2CompletedNCT06661902

University of Washington350 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Enrollment

350

Conditions

Prostate Cancer

Interventions

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Pain of Local Anesthetic Injection

Pain associated with the injection of local anesthetic, assessed by a written questionnaire (Visual Analogue Scale, 0 \[least\] to 10 \[worst pain\]).

Time frame: Within 20 seconds of completing the injection of all local anesthetic

Secondary Outcomes

Pain of the Prostate Biopsy

Pain associated with the biopsies of the prostate, assessed by a questionnaire (Visual Analogue Scale, 0 \[least\] to 10 \[worst pain\]).

Time frame: Within 10 minutes of completing the prostate biopsy, and on post-operative day 1

Willingness to perform another prostate biopsy in the future, if medically necessary

Assessed by a questionnaire (Visual Analogue Scale, 0 \[least likely\] to 10 \[most likely\])

Time frame: Within 10 minutes of completing the prostate biopsy, and on post-operative day 1

Incidence of adverse events

Will be assessed by patient self-report using an electronic written questionnaire. Will be assessed for inability to urinate, bleeding, allergic reaction, fever, or fatigue, or significant chills, or nausea/vomiting.

Time frame: Post-operative day 1