Local Anesthesia for Prostate Biopsy: Effects on Pain Control, Quality of Life, and Surgical Intervention
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 243
- 试验地点
- 1
- 主要终点
- Pain contol
研究概览
简要总结
Title: Local anesthesia for office biopsy of the prostate: effects on pain control, quality of life and surgical intervention.
Introduction: Local anesthetic should be administered prior to transrectal needle biopsy of the prostate to control pain in the office setting. Various centers have injected anesthetic in different regions in and around the prostate prior to biopsy. Patient experience with each technique has varied. We would like to determine which procedure provides the best pain control. In addition, we would like to know if the anesthetic placement has any effect on urinary patterns, bowel habits, and sexual function. Furthermore, for those patients found to have cancer and elect surgical treatment, we plan to evaluate if the anesthetic had an impact on surgical dissection of their prostate.
Methods: The investigators plan to identify those patients who require prostate biopsy for diagnosis. Each patient will be randomly assigned to a different anesthetic injection group. During the biopsy protocol, our nurse will monitor the patient?s pain level according to the visual analog score. The patient will complete a pre-biopsy questionnaire and two post-biopsy questionnaires administered at 1 and 4 weeks after biopsy. He will receive results of the prostate biopsy pathology report within 48 hours by calling his primary referral service.
详细描述
RESEARCH PROPOSAL AND PROTOCOL
TITLE Local anesthesia for prostate biopsy: Effects on pain control, quality of life, and surgical intervention.
SPECIFIC AIMS Local anesthetic (1% lidocaine) should be administered prior to transrectal needle biopsy of the prostate to control pain in the office setting. In this study, we would determine which location of injection manages pain best by comparing the patient?s subjective pain response as depicted by the visual analog score. In addition, we will evaluate how the prostate biopsy and anesthetic techniques changed the patient?s quality of life and determine what impact was observed during surgical dissection.
SIGNIFICANCE Transrectal ultrasound-guided needle biopsy of the prostate is the gold standard for diagnosing prostate cancer. We perform approximately 80 of these procedures per month in our office setting. This intervention often sparks anxiety in patients due to the pain that may be encountered. In fact, past patient surveys show that 50-90% of patients suffered significant pain during their prostate biopsy when local anesthesia was not used1. Since the year 2000, we have been injecting local anesthetic prior to the biopsy. This allows us to obtain an average of 10 to 12 samples from the gland. Overall, most patients are able to tolerate this procedure without significant morbidity.
The cost of an office biopsy at our clinic is close to $1800, while those done under anesthesia in an operating room can be over $7000. Patients may need to undergo this biopsy in a monitored setting if it is done at the time of an additional procedure or if a saturation biopsy is planned, where up to 30 samples may be taken. Other patients are done under anesthesia if they adamantly refuse office biopsy due to their anxiety over pain associated with the procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Our study will not exclude patients based on age or race. Any male patient seen in our clinic with the following conditions that warrant and consent to transrectal needle biopsy of the prostate would be recruited for this study:
- •Elevated serum PSA
- •Hypoechoic nodule incidentally discovered on transrectal ultrasound for other purposes
- •Abnormal digital rectal exam (DRE)
- •The following
排除标准
- •must be in place to prevent complications and interference with data interpretation:
- •Patients taking narcotics on a routine basis
- •Patients on Coumadin therapy
- •Patients with ano-rectal disease
- •Patients with history of prostatitis, pelvic pain, pelvic floor tension myalgia, or other pain syndromes
- •Patients with active prostate abscess or urinary tract infection
- •Patients with allergy to local anesthetic
结局指标
主要结局
Pain contol
次要结局
- Changes to voiding function
- Changes to bowel function
- Changes to sexual function
- Impact on surgical treatment