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NCT Number: NCT07258901

Postoperative Analgesia Practices After Percutaneous Nephrolithotomy

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.

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Key information

Conditions

Nephrolithiasis Agnosia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms Urogenital Diseases Urolithiasis Urologic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Cumulative opioid consumption

    Time frame: 24 hours

    Cumulative opioid consumption in the first 24 hours

Secondary outcomes

  1. Pain scores at rest and during movement

    Time frame: 0, 2, 6, 12, and 24 hours postoperatively

    Pain intensity measured using the Numeric Rating Scale (NRS), a validated 11-point pain scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores represent worse pain

  2. Time to first analgesic request

    Time frame: Postoperative 24 hours

    Time to first analgesic request

  3. Need for rescue analgesics

    Time frame: 24 hours

    Need for rescue analgesics

  4. Intraoperative opioid consumption

    Time frame: During surgery

    Intraoperative opioid consumption

  5. Antiemetic medication use

    Time frame: 24 hours

    Antiemetic medication use

  6. Patient satisfaction score

    Time frame: 24 hours postoperatively

    Patient satisfaction regarding postoperative analgesia, assessed using a Numeric Rating Scale (NRS) ranging from 0 to 10, where 0 represents no satisfaction and 10 represents the highest possible satisfaction. Higher scores indicate better satisfaction.

Sponsors and collaborators

Lead sponsor

Istinye University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 2, 2025
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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