BURN Study: Buffered Lidocaine in Reducing Pain from Prostate Biopsy

Phase 1

Not yet recruiting

• Conditions: Prostate Cancer
• Interventions: Drug: 1% Lidocaine HCL

• Registration Number: NCT06661902
• Lead Sponsor: University of Washington

Brief Summary

The goal of this clinical trial is to determine if Buffered Lidocaine may reduce the pain that patients experience during a prostate biopsy. It will also learn about the safety of Buffered Lidocaine. The main question it aims to answer is:

1) Does Buffered Lidocaine (1% Lidocaine + 8.4% Sodium Bicarbonate, in a 3:1 ratio) reduce the pain of local anesthetic injection during prostate biopsy, as compared to 1% Lidocaine

Researchers will compare the pain that patients report during a prostate biopsy after receiving either (A) Buffered Lidocaine or (B) 1% Lidocaine for their local anesthetic.

Participants will:

* Prior to the biopsy, complete a series of questionnaires determining their baseline pain and anxiety scores

* Undergo a prostate biopsy, with either Buffered Lidocaine or 1% Lidocaine as their local anesthetic

* Complete a series of questionnaires assessing the pain they experienced during and after the procedure, as well as any complications they may have experienced

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-25
• Study First Submitted QC: 2024-10-25
• Last Update Submitted: 2024-10-25
• Study First Posted: 2024-10-28
• Last Update Posted: 2024-10-28
• Study Start: 2025-02
• Primary Completion: 2026-02
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 300

Inclusion Criteria

1. Provision of signed and dated informed consent form

2. 18 years old or older

3. Biological males

4. Those with and without a prior diagnosis of prostate cancer

5. Recommended to undergo a prostate biopsy in the urology clinic. May include all of the following types of prostate biopsies:

   1. Transperineal or Transrectal
   2. Systematic or Targeted/Fusion Biopsy
   3. 12 core or >12cores
   4. Biopsy naïve or Prior biopsies

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Exclusion Criteria

1. Anorectal pathology precluding placement of a transrectal ultrasound
2. Diagnosis of chronic prostatitis, interstitial cystitis, pelvic pain syndrome
3. Concomitant chronic pain condition
4. Neurological condition affecting pain or sensorium (ex. spinal cord injury, stroke, multiple sclerosis, etc)
5. Prostate biopsy performed with any anesthesia other than local anesthetic (monitored anesthesia care, general anesthesia)
6. Prostate biopsy completed in the operating room
7. Patients who ultimately require additional local anesthetic beyond what is allotted in the study intervention
8. Patients taking anxiolytics in the 6-hours prior to the biopsy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Buffered Lidocaine	1% Lidocaine HCL	1% Lidocaine + 8.4% Sodium Bicarbonate, in a 3:1 ratio

Primary Outcome Measures

Name	Time	Method
Pain of Local Anesthetic Injection	Within 10 seconds of completing 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 Outcome Measures

Name	Time	Method
Pain of the Prostate Biopsy	(1) Within 5 minutes following conclusion of prostate biopsy, (2) On postoperative 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	1) Within 5 minutes following conclusion of prostate biopsy, (2) On postoperative day 1	Assessed by a questionnaire (Visual Analogue Scale, 0 \[least likely\] to 10 \[most likely\])
Adverse Events	Postoperative day 1	Patients will be asked if they experienced any complications from the prostate biopsy procedure necessitating healthcare evaluation, including (1) inability to urinate, (2) bleeding, (3) allergic reaction, (4) signs of infection

Trial Locations

Locations (1)

University of Washington; 🇺🇸 Seattle, Washington, United States