Nephrostomy Tract Infiltration for Pain Control After PCNL
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHitit University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Bupivacaine
DrugA 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
DrugStandard 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Nephrostomy Tract Bupivacaine InfiltrationExperimental treatment 2 interventions
Group B: Standard Systemic AnalgesiaActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 surgerySecondary outcomes
1
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 hours2
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 surgery3
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 surgerySponsors and contacts
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Source ClinicalTrials.gov