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. Administering buffered lidocaine may reduce pain in patients undergoing prostate biopsy.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06661902.
Locations matching your search criteria
United States
Washington
Seattle
Fred Hutch/University of Washington/Seattle Children's Cancer ConsortiumStatus: Active
Contact: Alexander Zhu
Phone: 949-633-6048
PRIMARY OBJECTIVE:
I. To determine whether buffered lidocaine (1% lidocaine + 8.4% sodium bicarbonate, in a 3:1 ratio) reduces the pain of local anesthetic injection, as compared to 1% lidocaine.
SECONDARY OBJECTIVES:
I. To determine whether buffered lidocaine reduces the pain of prostate biopsy, as compared to 1% lidocaine.
II. To determine whether buffered lidocaine affects the willingness of patients to perform another prostate biopsy in the future, as compared to 1% lidocaine.
III. To determine the safety of buffered lidocaine.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients receive SOC lidocaine via injection during SOC prostate biopsy on study.
ARM B: Patients receive buffered lidocaine via injection during SOC prostate biopsy on study.
After completion of study intervention, patients are followed up 1-2 days post-biopsy.
Trial PhasePhase I/II
Trial Typesupportive care
Lead OrganizationFred Hutch/University of Washington/Seattle Children's Cancer Consortium
Principal InvestigatorAlexander Zhu
