Clinical trial · Interventional
Buffered Lidocaine for Reducing Pain in Patients Undergoing Prostate Biopsy, BURN Trial
BURN Study: Buffered Lidocaine in Reducing Pain From Prostate Biopsy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biopsy of Prostate | Procedure | — | UNRESOLVED |
| Buffered Lidocaine (1% Lidocaine + 8.4% Sodium Bicarbonate, in a 3:1 ratio) | Drug | — | UNRESOLVED |
| Lidocaine | Drug | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm A (lidocaine)
- description
- Patients receive SOC lidocaine via injection during SOC prostate biopsy on study.
- interventionNames
- Drug: Lidocaine
- Procedure: Biopsy of Prostate
- Other: Questionnaire Administration
- type
- EXPERIMENTAL
- label
- Arm B (buffered lidocaine)
- description
- Patients receive buffered lidocaine via injection during SOC prostate biopsy on study. (1% Lidocaine + 8.4% Sodium Bicarbonate, in a 3:1 ratio)
- interventionNames
- Drug: Buffered Lidocaine (1% Lidocaine + 8.4% Sodium Bicarbonate, in a 3:1 ratio)
- Procedure: Biopsy of Prostate
- Other: Questionnaire Administration
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available