The Effect of Intraprostatic Local Anesthesia on Pain Perception During Transperineal Prostate Biopsy Under Local Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Pain During Transperineal Prostate Biopsy
研究概览
简要总结
Transperineal prostate biopsy has become the standard method for diagnosing prostate cancer because of its favorable safety profile and low infectious complication rates. However, pain and discomfort during the procedure remain important concerns that may negatively affect patient satisfaction and willingness to undergo repeat biopsy when necessary.
This prospective randomized controlled study aims to evaluate whether the addition of intraprostatic local anesthesia to standard perineal local anesthesia reduces pain during transperineal prostate biopsy. Fifty patients undergoing prostate biopsy under local anesthesia will be randomized into two groups. The first group will receive standard perineal local anesthesia, while the second group will receive additional intraprostatic local anesthesia.
Pain severity will be assessed before, during, and after the procedure using a visual analog scale (VAS). Anxiety and depression levels will be evaluated preoperatively using the Hospital Anxiety and Depression Scale (HADS). Patient-related factors, procedural characteristics, and post-procedural outcomes will also be recorded to identify factors associated with pain perception.
The results of this study may help optimize local anesthesia techniques and improve patient comfort during transperineal prostate biopsy.
详细描述
Transperineal prostate biopsy is currently considered the preferred approach for prostate cancer diagnosis because of its low risk of infectious complications and favorable safety profile. Despite these advantages, pain experienced during the procedure remains a significant concern and may adversely affect patient satisfaction, procedural tolerance, and acceptance of repeat biopsy when clinically indicated.
Pain during prostate biopsy is primarily related to the rich autonomic innervation of the prostatic capsule and stroma. Perineal local anesthesia is commonly used to reduce procedural discomfort; however, pain may still occur, particularly during needle sampling of the prostatic parenchyma. Intraprostatic local anesthetic infiltration has been proposed as an adjunctive technique to provide more comprehensive analgesia by directly targeting the biopsy area. Previous studies have suggested that the addition of intraprostatic anesthesia may further reduce pain during prostate biopsy procedures.
The objective of this prospective randomized controlled study is to investigate the impact of intraprostatic local anesthesia on pain perception during transperineal prostate biopsy performed under local anesthesia. In addition, the study aims to evaluate the association between procedural pain and patient-related factors, including anxiety and depression levels assessed by the Hospital Anxiety and Depression Scale (HADS), as well as clinical and procedural characteristics.
The findings of this study may contribute to the optimization of local anesthesia protocols and improve patient comfort during transperineal prostate biopsy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
盲法说明
Participants will be blinded to the assigned anesthesia technique. The urologist performing the biopsy will not be blinded due to the nature of the intervention. Pain scores and study outcomes will be assessed and analyzed by an outcomes assessor who is blinded to group 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
- •Male patients aged 18 years or older
- •Clinical indication for transperineal prostate biopsy based on elevated prostate-specific antigen (PSA) level and/or suspicious digital rectal examination findings
- •Ability to understand and complete the Hospital Anxiety and Depression Scale (HADS)
- •Ability to provide pain scores using a 10-point Visual Analog Scale (VAS)
- •Provision of written informed consent
排除标准
- •Previous history of prostate biopsy
- •Known hypersensitivity or contraindication to local anesthetic agents
- •Hematological disorders affecting coagulation
- •Active urinary tract infection
- •Neurological disorders that may affect pain perception
- •Psychiatric disorders that may affect pain assessment or completion of study -questionnaires
- •Inability to complete the HADS questionnaire or VAS assessment
- •Refusal to participate or inability to provide informed consent
结局指标
主要结局
Pain During Transperineal Prostate Biopsy
时间窗: During the biopsy procedure
Pain severity during transperineal prostate biopsy will be assessed using the Visual Analog Scale (VAS), a patient-reported pain scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores indicate greater pain severity. Pain scores will be compared between participants receiving perineal local anesthesia alone and those receiving additional intraprostatic local anesthesia.
次要结局
未报告次要终点
研究者
Tarik Emre Sener
Assos. Prof.
Marmara University