Kidney Calculi, Postoperative Pain
Conditions
Keywords
local anesthetic infiltration, Percutaneous nephrolithotomy, peritubal infiltration, postoperative pain
Brief 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.
Interventions
DRUGBupivacaine
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.
DRUGIntravenous 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.
Sponsors
Hitit University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to First Rescue Analgesic Requirement | 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. |
| Total Opioid Consumption During the First 24 Postoperative Hours | 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. |
| Requirement for Rescue Analgesia | 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. |
Countries
Turkey (Türkiye)
Contacts
CONTACTMUSTAFA SERDAR ÇAĞLAYAN
Outcome results
None listed