Buffered Lidocaine for Prostate Cancer Biopsy Pain

(BURN Trial)

Recruiting at 1 trial location

Overseen By Alexander Zhu, DO

Age: 18+

Sex: Male

Trial Phase: Phase 1 & 2

Sponsor: University of Washington

Must not be taking: Anxiolytics, Diuretics

Disqualifiers: Chronic prostatitis, Neurological conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 day

350 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if buffered lidocaine (a local anesthetic) can reduce pain during prostate biopsies. A prostate biopsy involves taking a small sample of prostate tissue, often causing discomfort. Participants will receive either standard lidocaine or buffered lidocaine to assess which more effectively eases pain. Men scheduled for a prostate biopsy, without chronic pain or neurological conditions, might be suitable for this study. As a Phase 1, Phase 2 trial, this research focuses on understanding the treatment's mechanism and measuring its effectiveness in an initial group, offering participants a chance to contribute to important medical advancements.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot take anxiolytics (medications for anxiety) in the 6 hours before the biopsy.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that buffered lidocaine might relieve pain without adding extra risks. One study found that using lidocaine with another cream greatly reduced pain during prostate biopsies without causing more complications. This suggests that the buffered version could be safe and effective, as it is already commonly used in other medical procedures to lessen pain. Although this trial is in its early stages, it aims to further test how well people tolerate buffered lidocaine during prostate biopsies. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about buffered lidocaine for prostate cancer biopsy pain because it offers a potentially superior method for managing discomfort during the procedure. Unlike standard lidocaine injections, buffered lidocaine combines 1% lidocaine with 8.4% sodium bicarbonate in a 3:1 ratio, which may reduce the acidity of the solution. This buffering could lead to faster onset and more effective pain relief, making the biopsy process more comfortable for patients. By enhancing the pain management protocol, this approach might improve patient experiences and outcomes during prostate cancer biopsies.

What evidence suggests that buffered lidocaine might be an effective treatment for reducing pain during prostate biopsy?

This trial will compare the effectiveness of standard lidocaine with buffered lidocaine in reducing pain during prostate biopsies. Research has shown that buffered lidocaine can help reduce pain during procedures like prostate biopsies. Specifically, studies have found that mixing lidocaine with sodium bicarbonate significantly lessens the pain from injections. Buffering the lidocaine makes it less acidic, reducing the burning sensation often felt with regular lidocaine. In other areas of medicine, using buffered lidocaine for pain relief is already common. Although it hasn't been widely studied for prostate biopsies yet, early results suggest it could make the procedure more comfortable. ^{1 2 3 6 7}

Who Is on the Research Team?

Alexander Zhu, DO

Principal Investigator

Fred Hutch/University of Washington Cancer Consortium

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Provision of signed and dated informed consent form

I am advised to have a prostate biopsy.

I am a biological male.

Exclusion Criteria

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

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

I have taken anxiety medication within 6 hours before a biopsy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Patients receive either SOC lidocaine or buffered lidocaine via injection during SOC prostate biopsy

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 days

1 visit (virtual or phone call)

What Are the Treatments Tested in This Trial?

Interventions

• 1% Lidocaine HCL
• Buffered Lidocaine

Trial Overview

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.

How Is the Trial Designed?

Group I: Arm B (buffered lidocaine) Experimental Treatment 3 Interventions

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

Group II: Arm A (lidocaine) Active Control 3 Interventions

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

1% Lidocaine HCL is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Lidocaine for:

• Local anesthesia
• Ventricular tachycardia
• Ventricular fibrillation
• Chronic pain
• Acute surgical pain

Approved in European Union as Lignocaine for:

• Local anesthesia
• Ventricular tachycardia
• Ventricular fibrillation
• Chronic pain
• Acute surgical pain

Approved in Canada as Lidocaine for:

• Local anesthesia
• Ventricular tachycardia
• Ventricular fibrillation
• Chronic pain
• Acute surgical pain

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

Published Research Related to This Trial

In a study of 200 patients undergoing prostate biopsy, the use of lidocaine-prilocaine cream significantly reduced pain during both the insertion of the ultrasound probe and the biopsy procedure compared to a placebo.

Younger patients (under 67 years) experienced greater pain relief from the anaesthetic compared to older patients, indicating that age may influence the effectiveness of this topical anaesthetic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perianal and intrarectal anaesthesia for transrectal biopsy of the prostate: a prospective randomized study comparing lidocaine-prilocaine cream and placebo. Raber, M., Scattoni, V., Roscigno, M., et al.[2018]

In a study involving 30 patients undergoing axillary brachial plexus anaesthesia, both lidocaine and prilocaine provided a similar mean onset time of surgical analgesia at 10 minutes, indicating their effectiveness as local anesthetics.

Pharmacokinetically, while both lidocaine and prilocaine were eliminated rapidly, prilocaine had a higher total body clearance compared to lidocaine, suggesting it may be metabolized more efficiently, making both drugs suitable options for regional anaesthesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the effects and disposition kinetics of lidocaine and (+/-)prilocaine in patients undergoing axillary brachial plexus block during day case surgery. Simon, MA., Vree, TB., Gielen, MJ., et al.[2021]

In a study of 198 patients undergoing prostate biopsy, periprostatic anesthesia with 2% lidocaine significantly reduced pain compared to both intrarectal lidocaine-prilocain cream and a control group receiving only sonographic gel.

The mean pain score for patients receiving periprostatic anesthesia was 2.5, while it was 4.8 for those using the cream and 5.1 for the control group, indicating that periprostatic anesthesia is the most effective method for pain management during the procedure, with no significant difference in adverse events among the groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pain during transrectal ultrasonography guided prostate biopsy: a randomized prospective trial comparing periprostatic infiltration with lidocaine with the intrarectal instillation of lidocaine-prilocain cream. Adamakis, I., Mitropoulos, D., Haritopoulos, K., et al.[2018]

In a study of 80 patients undergoing prostate biopsy, perianal application of lidocaine-prilocaine cream significantly reduced pain during probe insertion compared to no anesthesia, indicating its efficacy as a local anesthetic.

The results suggest that perianal anesthesia alone is sufficient to manage pain during the biopsy procedure, as there was no significant difference in overall pain scores between patients receiving perianal anesthesia and those receiving both perianal and intrarectal anesthesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is only perianal anesthesia with lidocaine-prilocaine cream sufficient to decrease the pain during transrectal ultrasound-guided prostate biopsy? A prospective randomized study. Kandirali, E., Ulukaradag, E., Uysal, B., et al.[2018]

In a study of 300 patients undergoing transrectal prostate biopsy, noninfiltrative anesthetics like lidocaine-prilocaine cream and lidocaine-ketorolac gel significantly reduced pain during the procedure, with lidocaine-prilocaine being most effective for probe-related pain and lidocaine-ketorolac for sampling-related pain.

Both anesthetic combinations were found to be safe and well-accepted by patients, with low complication rates, suggesting they are effective alternatives to traditional periprostatic infiltration for pain management during prostate biopsies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Noninfiltrative anesthesia for transrectal prostate biopsy: a randomized prospective study comparing lidocaine-prilocaine cream and lidocaine-ketorolac gel. Cormio, L., Lorusso, F., Selvaggio, O., et al.[2016]

A study involving 200 patients found that a combination of perianal-intrarectal lidocaine-prilocaine cream and lidocaine-ketorolac gel effectively relieved pain during transrectal prostate biopsy, providing similar pain relief to the traditional method that includes periprostatic nerve block.

The new combination not only matched the pain relief for probe insertion and sampling but also significantly reduced pain from periprostatic infiltration, leading to better patient compliance and suggesting it could replace the need for infiltrative anesthesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined perianal-intrarectal (PI) lidocaine-prilocaine (LP) cream and lidocaine-ketorolac gel provide better pain relief than combined PI LP cream and periprostatic nerve block during transrectal prostate biopsy. Cormio, L., Pagliarulo, V., Lorusso, F., et al.[2013]

A new gas chromatography-mass spectrometry (GC-MS) method was developed to accurately measure the absorption of prilocaine and lidocaine through the skin, showing good linearity in concentrations from 0.016 to 50.0 mg/L.

The method demonstrated high recovery rates (85.3% to 109.7%) and low variability (less than 10% relative standard deviation), making it a reliable and sensitive tool for analyzing these local anesthetics in transdermal studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Simultaneous determination of prilocaine and lidocaine in transdermal receiving fluid using gas chromatography-mass spectrometry]. Yang, Y., Zhang, W., Ye, L.[2016]

In a study involving 40 subjects undergoing superficial dermatosurgical procedures, the combination cream of 7% lignocaine and 7% tetracaine provided significantly better pain relief compared to the 2.5% lidocaine and 2.5% prilocaine cream, as measured by visual analogue scale scores.

The findings suggest that the lignocaine/tetracaine combination is an effective topical anesthetic for short-term use (30 minutes), allowing for quicker onset of analgesia and potentially improving the efficiency of dermatological procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Topical Anesthetics for Radiofrequency Ablation of Achrocordons: Eutectic Mixture of Lignocaine/Prilocaine versus Lidocaine/Tetracaine. Gahalaut, P., Mishra, N., Chauhan, S., et al.[2021]

In a study of 159 patients undergoing prostate biopsies, the combination of periprostatic nerve blockade and intrarectal lidocaine gel, as well as unilateral pudendal nerve blockade, significantly reduced pain during the procedure compared to no anesthesia.

The results indicated that while periprostatic nerve blockade alone did not show a significant difference in pain scores during probe insertion, it was effective in reducing pain during needle insertion and biopsy, highlighting its potential for improving patient comfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of four different anesthesia methods for relief of all pain during transrectal ultrasound-guided prostate biopsy. Inal, G., Adsan, O., Ugurlu, O., et al.[2021]

A new topical anesthetic gel containing 10% lidocaine and 10% prilocaine was tested in a randomized controlled trial with 300 children aged 5-8, showing significant effectiveness in reducing pain during local anesthetic injections compared to a control group without topical anesthesia.

The use of the topical anesthetic not only resulted in lower pain ratings on both the Wong-Baker Faces Pain Rating Scale and the FLACC scale, but also led to higher parental satisfaction, indicating its efficacy and safety for use on the oral mucosa without local or systemic side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness and Tolerability of a New Formulation of a Topical Anesthetic in Reduction of Pain and Parents' Satisfaction in Pediatric Dentistry. Ferrazzano, GF., Di Fabio, G., Gatto, R., et al.[2023]

The study found that a methylcellulose-based formulation of lidocaine and prilocaine (P-L) significantly enhances the absorption of these anesthetics through the skin compared to the carbopol-based Eutectic Mixture of Local Anesthesia (EMLA), with higher concentrations detected in the dermis.

Using a microdialysis system, the researchers demonstrated that the P-L formulation resulted in greater area under the concentration-time curve (AUC) and maximal concentrations (Cmax) for both lidocaine and prilocaine, indicating improved efficacy in local anesthesia delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous penetration kinetics of lidocaine and prilocaine in two local anesthetic formulations assessed by in vivo microdialysis in pigs. Wei, H., Chen, Y., Xu, L., et al.[2019]

Citations

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fredhutch.org

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Buffered Lidocaine in Reducing Pain from Prostate Biopsy ...

The goal of this clinical trial is to determine if Buffered Lidocaine may reduce the pain that patients experience during a prostate biopsy.

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withpower.com

withpower.com/trial/phase-2-prostatic-neoplasms-1-2025-87539

Buffered Lidocaine for Prostate Cancer Biopsy Pain

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cancer.gov

cancer.gov/clinicaltrials/NCI-2024-10011

Buffered Lidocaine for Reducing Pain in Patients ...

However, it has not been explored during prostate biopsies. Administering buffered lidocaine may reduce pain in patients undergoing prostate biopsy.

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sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1546144017304465

Impact of Sodium Bicarbonate-Buffered Lidocaine on ...

Overall, buffering lidocaine with sodium bicarbonate significantly reduced pain during intraparenchymal injections, and additional pain reduction was found in ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8162227/

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This study has shown that using sodium bicarbonate with lidocaine significantly decreased pain sensation at the injection site when used for deep visceral ...

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sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0022534701682971

The Journal of Urology

The combination of DS and lidocaine PPNB provides good additional pain relief during and after biopsy without any increased risk of complications. Pain scores ...

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link.springer.com

link.springer.com/article/10.1007/s00345-023-04723-2

Evolution of anxiety management in prostate biopsy under ...

A randomized controlled trial (RCT) conducted in 2014 that included 60 patients undergoing TR-PB found no improvement on pain perception after ...