Prostate Cancer
Conditions
Keywords
prostate cancer, prostate biopsy, transperineal biopsy, transrectal biopsy, MRI fusion biopsy, buffered lidocaine, sodium bicarbonate, Local anesthesia, lidocaine
Brief summary
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.
Detailed 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.
Interventions
DRUGBuffered Lidocaine (1% Lidocaine + 8.4% Sodium Bicarbonate, in a 3:1 ratio)
Given via injection
DRUGLidocaine
Given via injection
PROCEDUREBiopsy of Prostate
Undergo SOC prostate biopsy
OTHERQuestionnaire Administration
Ancillary studies
Sponsors
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The Investigational Drug Services team will be unblinded to the patient's randomization status. During statistical analysis of the data, the statistician will be concealed to the randomization allocation.
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain of Local Anesthetic Injection | Within 20 seconds of completing the injection of all local anesthetic | Pain associated with the injection of local anesthetic, assessed by a written questionnaire (Visual Analogue Scale, 0 \[least\] to 10 \[worst pain\]). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain of the Prostate Biopsy | Within 10 minutes of completing the prostate biopsy, and on post-operative day 1 | Pain associated with the biopsies of the prostate, assessed by a questionnaire (Visual Analogue Scale, 0 \[least\] to 10 \[worst pain\]). |
| Willingness to perform another prostate biopsy in the future, if medically necessary | Within 10 minutes of completing the prostate biopsy, and on post-operative day 1 | Assessed by a questionnaire (Visual Analogue Scale, 0 \[least likely\] to 10 \[most likely\]) |
| Incidence of adverse events | Post-operative day 1 | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAlexander Zhu, DO
Fred Hutch/University of Washington Cancer Consortium
Outcome results
None listed