Nephrostomy Tract Infiltration for Pain Control After PCNL

NCT07721571 · tracked via the Priya Life Science Turkey tracker

Sponsor

Hitit University

Phase

Not applicable

Started

2026-07-17

Last updated

2026-07-23

Condition(s) studied

Postoperative PainKidney Calculi

Investigational drug(s) / intervention(s)

Bupivacaine →Intravenous Tramadol and Paracetamol

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.

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.

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

Inclusion Criteria: * 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 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 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

Primary outcome measure(s)

Postoperative Pain Intensity Assessed Using the Visual Analog Scale — 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.

Trial sites (1)

Facility	City	Region	Status
Department of Urology, Hitit University Çorum Erol Olçok Training and Research Hospital, Çorum, Türkiye	Çorum	Çorum	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07721571 on ClinicalTrials.gov ↗ ← All trials in Turkey