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临床试验/NCT07258901
NCT07258901
尚未招募
不适用

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

Istinye University1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2025年12月1日最近更新:

概览

阶段
不适用
状态
尚未招募
入组人数
75
试验地点
1
主要终点
Cumulative opioid consumption

概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Cumulative opioid consumption

时间窗: 24 hours

Cumulative opioid consumption in the first 24 hours

次要结局

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

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

İlke Dolgun

assoc prof

Istinye University

研究点 (1)

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