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Nephrostomy Tract Infiltration for Pain Control After PCNL

RecruitingNAAges 18 Years - 75 YearsAllHitit University
NCT07721571 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 infiltr

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📋 Eligibility rules (as published)
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
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What it tests

  • Bupivacaine
  • Intravenous Tramadol and Paracetamol
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Where

1 site
Department of Urology, Hitit University Çorum Erol Olçok Training and Research Hospital, Çorum, Türkiye
Çorum, Turkey (Türkiye)
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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