Buffered Lidocaine for Prostate Cancer Biopsy Pain

(BURN Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Alexander Zhu, DO

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: University of Washington

Must not be taking: Anxiolytics, Diuretics

Disqualifiers: Chronic prostatitis, Neurological conditions, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the drug Buffered Lidocaine for reducing pain during prostate cancer biopsy?

Research shows that using lidocaine for periprostatic anesthesia significantly reduces pain during prostate biopsy compared to no anesthesia or other forms of lidocaine application, such as creams. This suggests that Buffered Lidocaine could be effective in reducing biopsy pain. ^{1 2 3 4 5}

Is buffered lidocaine safe for use in humans?

Lidocaine, also known by various names, is generally considered safe for use in humans as a local anesthetic. Studies have shown it to be effective in pain control with minimal side effects when used in appropriate formulations and dosages. ^{1 6 7 8 9}

How does buffered lidocaine differ from other drugs for prostate cancer biopsy pain?

Buffered lidocaine is unique because it is designed to reduce the acidity of lidocaine, potentially decreasing the pain associated with its injection. This could make it more comfortable compared to standard lidocaine or other anesthetic methods used during prostate cancer biopsies. ^{2 3 4 10 11}

Research Team

Alexander Zhu, DO

Principal Investigator

Fred Hutch/University of Washington Cancer Consortium

Eligibility Criteria

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 18 years old or older.

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.

Trial Timeline

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)

Treatment Details

Interventions

• 1% Lidocaine HCL (Local Anesthetic)
• Buffered Lidocaine (Local Anesthetic)

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.

Participant Groups

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 Canada for the following indications:

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+

Dr. Timothy H. Dellit

University of Washington

Chief Executive Officer since 2023

MD from University of Washington

Dr. Anneliese Schleyer

University of Washington

Chief Medical Officer since 2023

MD, MHA

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. Egypt pubmed.ncbi.nlm.nih.gov

Comparison of Topical Anesthetics for Radiofrequency Ablation of Achrocordons: Eutectic Mixture of Lignocaine/Prilocaine versus Lidocaine/Tetracaine. [2021]

2. England 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. [2013]

3. Germany 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. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Noninfiltrative anesthesia for transrectal prostate biopsy: a randomized prospective study comparing lidocaine-prilocaine cream and lidocaine-ketorolac gel. [2016]

5. England 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. [2018]

6. Switzerland 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. [2023]

7. New Zealand 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. [2021]

8. China pubmed.ncbi.nlm.nih.gov

[Simultaneous determination of prilocaine and lidocaine in transdermal receiving fluid using gas chromatography-mass spectrometry]. [2016]

9. Japan pubmed.ncbi.nlm.nih.gov

Percutaneous penetration kinetics of lidocaine and prilocaine in two local anesthetic formulations assessed by in vivo microdialysis in pigs. [2019]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Comparison of four different anesthesia methods for relief of all pain during transrectal ultrasound-guided prostate biopsy. [2021]

11. Switzerland 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. [2018]