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Nephrostomy Tract Infiltration for Pain Control After PCNL

2026年10月4日 更新者：Mustafa Serdar CAGLAYAN、Hitit University

Efficacy of Nephrostomy Tract Local Anesthetic Infiltration for Postoperative Pain Control Following Prone Percutaneous Nephrolithotomy: A Prospective Randomized Controlled Trial

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.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

60

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 土耳其（türkiye）
    • Çorum
      • Çorum、Çorum、土耳其（türkiye）、19040
        • 招聘中
        • Department of Urology, Hitit University Çorum Erol Olçok Training and Research Hospital, Çorum, Türkiye
        • 副研究员：
          • AHMET TAŞCI
        • 接触：
        • 副研究员：
          • METİN KIZGIN

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 75年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Adults aged 18 to 75 years
  • Scheduled to undergo elective percutaneous nephrolithotomy in the prone position
  • Classified as American Society of Anesthesiologists (ASA) physical status I-III
  • Able to understand and complete postoperative pain assessments using the Visual Analog Scale (VAS)
  • Willing to participate in the study
  • Provision of written informed consent

Exclusion Criteria:

  • 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 (ASA) 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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：预防
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Nephrostomy Tract Bupivacaine Infiltration

Participants in this arm will receive standard postoperative systemic analgesia. In addition, at the end of percutaneous nephrolithotomy, 20 mL of 0.25% bupivacaine will be infiltrated along the nephrostomy tract, including the skin, subcutaneous tissue, muscular layers, and tissues surrounding the nephrostomy tract.
药品：Bupivacaine

A total of 20 mL of 0.25% bupivacaine will be administered by local infiltration along the nephrostomy tract at the end of surgery. The infiltration will include the skin, subcutaneous tissue, muscular layers, and tissues surrounding the nephrostomy tract.

其他名称：
  • 盐酸布比卡因
  • Nephrostomy tract local anesthetic infiltration
  • Peritubal bupivacaine infiltration
药品：Intravenous Tramadol and Paracetamol

Standard postoperative systemic analgesia consisting of intravenous tramadol and intravenous paracetamol will be administered according to the institutional analgesia protocol. Rescue opioid analgesia will be provided when clinically required.

其他名称：
  • Standard postoperative analgesia
  • Intravenous tramadol and acetaminophen
有源比较器：Standard Systemic Analgesia

Participants in this arm will receive the standard postoperative systemic analgesia protocol, including intravenous tramadol and intravenous paracetamol. Rescue opioid analgesia will be administered when clinically required. No local or regional analgesic intervention will be performed.
药品：Intravenous Tramadol and Paracetamol

Standard postoperative systemic analgesia consisting of intravenous tramadol and intravenous paracetamol will be administered according to the institutional analgesia protocol. Rescue opioid analgesia will be provided when clinically required.

其他名称：
  • Standard postoperative analgesia
  • Intravenous tramadol and acetaminophen

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Postoperative Pain Intensity Assessed Using the Visual Analog Scale
大体时间：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.
At 1, 6, 12, and 24 hours after surgery

次要结果测量

结果测量
措施说明
大体时间
Time to First Rescue Analgesic Requirement
大体时间：From the end of surgery until the first rescue analgesic administration, within the first 24 postoperative hours

The time from the end of surgery to the first administration of rescue analgesic medication will be recorded in minutes. A longer duration indicates a prolonged postoperative analgesic effect.
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
大体时间：During the first 24 hours after surgery

The total amount of opioid analgesics administered during the first 24 hours after surgery will be recorded. When different opioid agents are used, doses will be converted to intravenous morphine milligram equivalents for comparison between groups.
During the first 24 hours after surgery
Requirement for Rescue Analgesia
大体时间：During the first 24 hours after surgery

The number and proportion of participants requiring at least one dose of rescue analgesic medication will be compared between the study groups.
During the first 24 hours after surgery

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Hitit University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年7月17日

初级完成 (估计的)

2027年1月11日

研究完成 (估计的)

2027年6月11日

研究注册日期

首次提交

2026年7月18日

首先提交符合 QC 标准的

2026年7月18日

首次发布 (实际的)

2026年7月23日

研究记录更新

最后更新发布 (实际的)

2026年10月6日

上次提交的符合 QC 标准的更新

2026年10月4日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • ETIK-2026-28

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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