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Not yet recruiting NCT07258901

Postoperative Analgesia Practices After Percutaneous Nephrolithotomy

Observational Nephrolithiasis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Nephrolithiasis. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Optimizing Postoperative Pain Management After Percutaneous Nephrolithotomy: A Comparative Clinical Assessment

Overview

This prospective observational study aims to evaluate the effectiveness and safety of different postoperative analgesia methods used in patients undergoing percutaneous nephrolithotomy (PCNL). Analgesia techniques are determined independently by the responsible anesthesiologist as part of routine clinical practice, and the study team does not intervene in treatment decisions.

Detailed description

This is a prospective observational clinical study designed to examine the impact of various postoperative analgesia strategies on pain outcomes in patients undergoing percutaneous nephrolithotomy (PCNL). In routine practice at the participating center, regional block techniques and intravenous analgesia protocols are commonly used, and different anesthesiologists may choose different postoperative analgesia approaches.

All patients will undergo standard general anesthesia according to institutional protocols. Intraoperative monitoring will include heart rate, mean arterial pressure, oxygen saturation, duration of surgery, opioid consumption, and intraoperative complications. Postoperative follow-up will include assessment of pain scores (NRS) at 0, 2, 6, 12, and 24 hours, cumulative opioid consumption, need for rescue analgesics, time to first analgesic request, incidence of postoperative nausea and vomiting (PONV), antiemetic use, patient satisfaction, and any analgesia-related adverse events.

Demographic characteristics (age, sex, BMI, ASA status), stone features (location, side, volume), and intraoperative variables will be recorded. Data will be collected prospectively and stored securely.

The primary goal is to compare the effect of different postoperative analgesia methods on cumulative opioid use in the first 24 hours. Secondary aims include evaluating pain scores, rescue analgesic need, intraoperative opioid use, time to first analgesic request, PONV incidence, patient satisfaction, and adverse effects.

Primary outcome measures

  • Cumulative opioid consumption [Time frame: 24 hours]
Secondary outcome measures (6)
  • Pain scores at rest and during movement [Time frame: 0, 2, 6, 12, and 24 hours postoperatively]
  • Time to first analgesic request [Time frame: Postoperative 24 hours]
  • Need for rescue analgesics [Time frame: 24 hours]
  • Intraoperative opioid consumption [Time frame: During surgery]
  • Antiemetic medication use [Time frame: 24 hours]
  • Patient satisfaction score [Time frame: 24 hours postoperatively]

Eligibility criteria

Inclusion criteria

  • Adults aged 18-65 years
  • ASA physical status I-III
  • Undergoing unilateral PCNL
  • Providing written informed consent

Exclusion criteria

  • Known allergy to local anesthetics

Coagulopathy or contraindication to regional anesthesia

BMI > 35 kg/m²

Cognitive or communication impairment affecting pain evaluation

Neurological or psychiatric disorders

Musculoskeletal abnormalities

Chronic opioid use, alcohol or substance abuse history

Previous PCNL or open renal surgery on the same side

Refusal to participate

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Turkey (Türkiye) · 1 center
  • Haseki Training and Research Hospital — Istanbul

Identifiers

NCT: NCT07258901 · 231-2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗