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临床试验/NCT00422708
NCT00422708已完成4 期

Local Anesthesia for Prostate Biopsy: Effects on Pain Control, Quality of Life, and Surgical Intervention

Mayo Clinic2 个研究点 分布在 1 个国家目标入组 243 人开始时间: 2006年6月最近更新:
适应症

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
2
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

入选标准

  • 未提供

排除标准

  • 未提供

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

研究者

发起方
Mayo Clinic
申办方类型
Other

研究点 (2)

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