Nephrostomy Tract Infiltration to Ease Pain After Percutaneous Nephrolithotomy
Official title: Efficacy of Nephrostomy Tract Local Anesthetic Infiltration for Postoperative Pain Control Following Prone Percutaneous Nephrolithotomy: A Prospective Randomized Controlled Trial
Run by Hitit University · NCT07721571 · Data updated 2026-11-12
This trial tests whether injecting local anesthetic into the nephrostomy tract after PCNL helps reduce postoperative pain for adults undergoing the procedure.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Hitit University Academic / other |
| Locations | 1 site (Çorum, Çorum) |
| Status | Recruiting |
| Started | July 17, 2026 |
| Main results expected | January 11, 2027 |
| Study ends | June 11, 2027 |
| Registry record updated | October 6, 2026 |
| Trial ID | NCT07721571 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–75 undergoing elective prone PCNL, ASA I–III, capable of completing postoperative pain assessments and providing consent.
✕Probably not a fit
Patients with allergies to bupivacaine, coagulation disorders, chronic opioid use, neurological or psychiatric conditions affecting pain assessment, active infection, ASA IV or higher, or needing multiple tracts may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective, randomized study compares standard postoperative analgesia with and without nephrostomy tract infiltration of 20 mL of 0.25% bupivacaine at the end of prone PCNL. Pain will be measured with the Visual Analog Scale at 1, 6, 12, and 24 hours after surgery. Secondary outcomes include time to first analgesic use, total opioid consumption in 24 hours, need for rescue analgesia, time to mobilization, length of hospital stay, and any treatment-related complications. The aim is to determine if this simple local infiltration can provide safer, more effective pain control and reduce analgesic requirements after surgery.
Why it matters
Potential benefit: If successful, patients may experience less pain and lower opioid use after PCNL, with potential for faster recovery.
How similar studies have gone: Prior work in regional and local anesthesia for stone surgery has shown pain reduction with local infiltration at access sites, supporting the approach's potential.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Department of Urology, Hitit University Çorum Erol Olçok Training and Research Hospital, Çorum, Türkiye
Çorum, Çorum, Turkey (Türkiye) Recruiting
Study contacts
- Study coordinator: Mustafa Serdar Çağlayan
- Email: serdar.09.09@hotmail.com
- Phone: +905074311951
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.