Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-26 @ 2:47 AM
Study NCT ID:
NCT06661902
Status:
RECRUITING
Last Update Posted:
2025-08-03
First Post:
2024-10-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Buffered Lidocaine for Reducing Pain in Patients Undergoing Prostate Biopsy, BURN Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008012', 'term': 'Lidocaine'}, {'id': 'D017693', 'term': 'Sodium Bicarbonate'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D001639', 'term': 'Bicarbonates'}, {'id': 'D002254', 'term': 'Carbonates'}, {'id': 'D002255', 'term': 'Carbonic Acid'}, {'id': 'D017554', 'term': 'Carbon Compounds, Inorganic'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': "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."}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 350}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-01', 'studyFirstSubmitDate': '2024-10-25', 'studyFirstSubmitQcDate': '2024-10-25', 'lastUpdatePostDateStruct': {'date': '2025-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain of Local Anesthetic Injection', 'timeFrame': 'Within 20 seconds of completing the injection of all local anesthetic', 'description': 'Pain associated with the injection of local anesthetic, assessed by a written questionnaire (Visual Analogue Scale, 0 \\[least\\] to 10 \\[worst pain\\]).'}], 'secondaryOutcomes': [{'measure': 'Pain of the Prostate Biopsy', 'timeFrame': 'Within 10 minutes of completing the prostate biopsy, and on post-operative day 1', 'description': 'Pain associated with the biopsies of the prostate, assessed by a questionnaire (Visual Analogue Scale, 0 \\[least\\] to 10 \\[worst pain\\]).'}, {'measure': 'Willingness to perform another prostate biopsy in the future, if medically necessary', 'timeFrame': 'Within 10 minutes of completing the prostate biopsy, and on post-operative day 1', 'description': 'Assessed by a questionnaire (Visual Analogue Scale, 0 \\[least likely\\] to 10 \\[most likely\\])'}, {'measure': 'Incidence of adverse events', 'timeFrame': 'Post-operative day 1', 'description': '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['prostate cancer', 'prostate biopsy', 'transperineal biopsy', 'transrectal biopsy', 'MRI fusion biopsy', 'buffered lidocaine', 'sodium bicarbonate', 'Local anesthesia', 'lidocaine'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'OUTLINE: Patients are randomized to 1 of 2 arms.\n\nARM A: Patients receive SOC lidocaine via injection during SOC prostate biopsy on study.\n\nARM B: Patients receive buffered lidocaine via injection during SOC prostate biopsy on study.\n\nAfter completion of study intervention, patients are followed up 1-2 days post-biopsy.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provision of signed and dated informed consent form\n* 18 years old or older\n* Patients with prostates\n* Those with and without a prior diagnosis of prostate cancer\n* 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:\n\n * Transperineal or transrectal\n * Systematic or targeted/fusion biopsy\n * 12 core biopsy or \\> 12cores\n * Biopsy naïve or prior biopsy\n\nExclusion Criteria:\n\n* Anorectal pathology precluding placement of a transrectal ultrasound\n* Diagnosis of chronic prostatitis, interstitial cystitis, pelvic pain syndrome\n* Concomitant chronic pain condition\n* Neurological condition affecting pain or sensorium (ex. spinal cord injury, stroke, multiple sclerosis, etc.)\n* Prostate biopsy performed with any anesthesia other than local anesthetic (monitored anesthesia care, general anesthesia)\n* Prostate biopsy completed in the operating room\n* Patients who ultimately require additional local anesthetic beyond what is allotted in the study intervention\n* Patients taking anxiolytics in the 6-hours prior to the biopsy\n* 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'}, 'identificationModule': {'nctId': 'NCT06661902', 'acronym': 'BURN', 'briefTitle': 'Buffered Lidocaine for Reducing Pain in Patients Undergoing Prostate Biopsy, BURN Trial', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'BURN Study: Buffered Lidocaine in Reducing Pain From Prostate Biopsy', 'orgStudyIdInfo': {'id': 'RG1125023'}, 'secondaryIdInfos': [{'id': 'STUDY00021446', 'type': 'OTHER', 'domain': 'Fred Hutch/University of Washington Cancer Consortium'}, {'id': 'NCI-2024-10011', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}]}, 'armsInterventionsModule': {'armGroups': [{'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']}], 'interventions': [{'name': 'Buffered Lidocaine (1% Lidocaine + 8.4% Sodium Bicarbonate, in a 3:1 ratio)', 'type': 'DRUG', 'description': 'Given via injection', 'armGroupLabels': ['Arm B (buffered lidocaine)']}, {'name': 'Lidocaine', 'type': 'DRUG', 'description': 'Given via injection', 'armGroupLabels': ['Arm A (lidocaine)']}, {'name': 'Biopsy of Prostate', 'type': 'PROCEDURE', 'otherNames': ['Prostate Biopsy'], 'description': 'Undergo SOC prostate biopsy', 'armGroupLabels': ['Arm A (lidocaine)', 'Arm B (buffered lidocaine)']}, {'name': 'Questionnaire Administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Arm A (lidocaine)', 'Arm B (buffered lidocaine)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98195', 'city': 'Seattle', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Alexander Zhu, DO', 'role': 'CONTACT', 'email': 'azhu5@uw.edu', 'phone': '949-633-6048'}, {'name': 'Alexander Zhu, DO', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Fred Hutch/University of Washington Cancer Consortium', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'centralContacts': [{'name': 'Alexander Zhu, DO', 'role': 'CONTACT', 'email': 'azhu5@uw.edu', 'phone': '949-633-6048'}], 'overallOfficials': [{'name': 'Alexander Zhu, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fred Hutch/University of Washington Cancer Consortium'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'This is a single center, investigator initiated trial.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}