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NCT Number: NCT07721571

Nephrostomy Tract Infiltration for Pain Control After PCNL

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.

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Key information

Conditions

Postoperative Pain Calculi Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Calculi Kidney Diseases Male Urogenital Diseases Nephrolithiasis Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Urinary Calculi Urogenital Diseases Urolithiasis Urologic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Urology, Hitit University Çorum Erol Olçok Training and Research Hospital, Çorum, Türkiye

Çorum, 19040, Turkey (Türkiye)

Location status: Recruiting

Location contact

AHMET TAŞCI

SUB_INVESTIGATOR

METİN KIZGIN

SUB_INVESTIGATOR

MUSA EKİCİ

CONTACT

[email protected]

+90 505 751 6341

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bupivacaine

Drug

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.

Other names: Bupivacaine hydrochloride, Nephrostomy tract local anesthetic infiltration, Peritubal bupivacaine infiltration

Intravenous Tramadol and Paracetamol

Drug

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.

Other names: Standard postoperative analgesia, Intravenous tramadol and acetaminophen

Primary outcomes

  1. Postoperative Pain Intensity Assessed Using the Visual Analog Scale

    Time frame: 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.

Secondary outcomes

  1. Time to First Rescue Analgesic Requirement

    Time frame: 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.

  2. Total Opioid Consumption During the First 24 Postoperative Hours

    Time frame: 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.

  3. Requirement for Rescue Analgesia

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

MUSTAFA SERDAR ÇAĞLAYAN

CONTACT

[email protected]

+905074311951

Sponsors and collaborators

Lead sponsor

Hitit University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 23, 2026
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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