An interventional study of Bupivacaine and Intravenous Tramadol and Paracetamol in Postoperative Pain and Kidney Calculi, sponsored by Hitit University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-06.
Sponsored by Hitit University · Not applicable, Interventional, and Prevention
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.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's planned enrollment of 60 is below the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Hitit University is the lead sponsor of 79 studies on the registry; 28 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: Bupivacaine · Drug: Intravenous Tramadol and Paracetamol
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.
Drug: Intravenous Tramadol and Paracetamol
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.
Also known as: Bupivacaine hydrochloride, Nephrostomy tract local anesthetic infiltration, Peritubal bupivacaine infiltration
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.
Also known as: Standard postoperative analgesia, Intravenous tramadol and acetaminophen
Postoperative Pain Intensity Assessed Using the Visual Analog Scale
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.
Time frame: At 1, 6, 12, and 24 hours after surgery
Time to First Rescue Analgesic Requirement
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.
Time frame: 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
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.
Time frame: During the first 24 hours after surgery
Requirement for Rescue Analgesia
The number and proportion of participants requiring at least one dose of rescue analgesic medication will be compared between the study groups.
Time frame: During the first 24 hours after surgery
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Hitit University