Efficacy of Nephrostomy Tract Local Anesthetic Infiltration for Postoperative Pain Control Following Prone Percutaneous Nephrolithotomy: A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Postoperative Pain Intensity Assessed Using the Visual Analog Scale
研究概览
简要总结
This prospective, randomized, controlled clinical trial aims to evaluate the effectiveness of nephrostomy tract local anesthetic infiltration for postoperative pain control in patients undergoing prone percutaneous nephrolithotomy. Eligible patients will be randomly assigned to either a control group receiving standard systemic postoperative analgesia or an intervention group receiving standard analgesia plus infiltration of 20 mL of 0.25% bupivacaine along the nephrostomy tract at the end of surgery. Postoperative pain will be assessed using the Visual Analog Scale at 1, 6, 12, and 24 hours. Secondary outcomes will include time to first analgesic requirement, total opioid consumption during the first 24 hours, need for rescue analgesia, time to mobilization, length of hospital stay, and treatment-related complications. The study is designed to determine whether nephrostomy tract infiltration provides a simple, safe, and effective adjunct for reducing pain and analgesic consumption after percutaneous nephrolithotomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 to 75 years
- •Scheduled to undergo elective percutaneous nephrolithotomy in the prone position
- •Classified as American Society of Anesthesiologists physical status I-III
- •Able to understand and complete postoperative pain assessments using the Visual Analog Scale
- •Willing to participate in the study
- •Provision of written informed consent
排除标准
- •Known allergy or hypersensitivity to bupivacaine or other local anesthetic agents Coagulopathy or clinically significant bleeding disorder Chronic opioid use History of a neurological disorder that may affect pain perception or assessment Neurological or psychiatric condition preventing reliable postoperative pain assessment Active urinary tract infection or sepsis American Society of Anesthesiologists physical status IV or higher Requirement for multiple percutaneous access tracts Bilateral percutaneous nephrolithotomy Requirement for postoperative intensive care Refusal or inability to provide written informed consent
结局指标
主要结局
Postoperative Pain Intensity Assessed Using the Visual Analog Scale
时间窗: At 1, 6, 12, and 24 hours after surgery
Postoperative pain intensity will be assessed using the Visual Analog Scale (VAS). Patients will rate their pain on a scale from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. VAS scores will be compared between the nephrostomy tract bupivacaine infiltration group and the standard systemic analgesia group.
次要结局
- Time to First Rescue Analgesic Requirement(From the end of surgery until the first rescue analgesic administration, within the first 24 postoperative hours)
- Total Opioid Consumption During the First 24 Postoperative Hours(During the first 24 hours after surgery)
- Requirement for Rescue Analgesia(During the first 24 hours after surgery)
研究者
Mustafa Serdar CAGLAYAN
Assistant Professor, MD
Hitit University