BURN Study: Buffered Lidocaine in Reducing Pain From Prostate Biopsy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- Pain of Local Anesthetic Injection
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Arm A (lidocaine)
Patients receive SOC lidocaine via injection during SOC prostate biopsy on study.
干预措施: Lidocaine (Drug)
Arm A (lidocaine)
Patients receive SOC lidocaine via injection during SOC prostate biopsy on study.
干预措施: Biopsy of Prostate (Procedure)
Arm A (lidocaine)
Patients receive SOC lidocaine via injection during SOC prostate biopsy on study.
干预措施: Questionnaire Administration (Other)
Arm B (buffered lidocaine)
Patients receive buffered lidocaine via injection during SOC prostate biopsy on study. (1% Lidocaine + 8.4% Sodium Bicarbonate, in a 3:1 ratio)
干预措施: Biopsy of Prostate (Procedure)
Arm B (buffered lidocaine)
Patients receive buffered lidocaine via injection during SOC prostate biopsy on study. (1% Lidocaine + 8.4% Sodium Bicarbonate, in a 3:1 ratio)
干预措施: Questionnaire Administration (Other)
Arm B (buffered lidocaine)
Patients receive buffered lidocaine via injection during SOC prostate biopsy on study. (1% Lidocaine + 8.4% Sodium Bicarbonate, in a 3:1 ratio)
干预措施: Buffered Lidocaine (1% Lidocaine + 8.4% Sodium Bicarbonate, in a 3:1 ratio) (Drug)
结局指标
主要结局
Pain of Local Anesthetic Injection
时间窗: Within 20 seconds of completing the 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 \[worst pain\]).
次要结局
- Pain of the Prostate Biopsy(Within 10 minutes of completing the prostate biopsy, and on post-operative day 1)
- Willingness to perform another prostate biopsy in the future, if medically necessary(Within 10 minutes of completing the prostate biopsy, and on post-operative day 1)
- Incidence of adverse events(Post-operative day 1)