Nociception Level Index Monitoring During Cesarean Section (NOL-CS)
Effect of Nociception Level Index-Guided Intraoperative Analgesia on Postoperative Pain Management During Elective Cesarean Section
研究概览
地位
详细说明
Postoperative pain following cesarean section remains an important clinical concern because inadequate analgesia may delay maternal recovery, increase opioid consumption, and negatively affect early breastfeeding and maternal-infant bonding. Conventional intraoperative monitoring does not directly assess nociceptive responses, making individualized analgesic administration challenging.
The Nociception Level (NOL) index is a multiparametric monitoring system that integrates photoplethysmography, galvanic skin response, peripheral temperature, and accelerometer signals to provide an objective assessment of nociception during anesthesia. This technology may enable more individualized opioid administration based on the patient's nociceptive response.
In this prospective randomized controlled trial, patients undergoing elective cesarean section under general anesthesia were randomized to receive either NOL-guided intraoperative analgesia or standard intraoperative monitoring. In the intervention group, fentanyl administration after fetal delivery was guided by the NOL index, whereas patients in the control group received conventional hemodynamic-guided analgesia.
Postoperative pain was evaluated using the visual analog scale (VAS) at predefined time points during the first 24 postoperative hours. Rescue opioid requirements, total postoperative analgesic consumption, and time to first breastfeeding were also recorded. The study was designed to determine whether NOL-guided analgesia could improve early postoperative pain control and reduce postoperative opioid requirements compared with conventional monitoring.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Sultangazi
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Istanbul、Sultangazi、土耳其（türkiye）、34256
- University of Health Sciences Türkiye Haseki Training and Research Hospital
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Female patients undergoing elective cesarean section under general anesthesia.
- Ability to provide written informed consent.
Exclusion Criteria:
- Refusal to participate.
- Emergency cesarean section.
- High-risk pregnancy (including hypertensive disorders of pregnancy, diabetes mellitus, preterm labor, or fetal growth restriction).
- Placental abnormalities.
- History of allergy to any study medication.
- History of malignant hyperthermia.
- Alcohol or substance abuse.
- Severe cardiac disease or severe arrhythmia.
- Peripheral vascular disease.
- Renal or hepatic failure.
- Contraindication to corticosteroid administration.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：NOL-Guided Analgesia Group
Patients undergoing elective cesarean section under general anesthesia were monitored intraoperatively using the Nociception Level (NOL) index in addition to standard monitoring.
After fetal delivery, fentanyl was administered in 25-mcg boluses when the NOL value remained above 25 for more than 1 minute, with a minimum interval of 5 minutes between doses.
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The Nociception Level (NOL) index was used to guide intraoperative fentanyl administration after fetal delivery.
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有源比较器：Standard Monitoring Group
Patients undergoing elective cesarean section under general anesthesia received standard intraoperative monitoring.
Intraoperative analgesic management was performed according to conventional clinical practice without NOL index guidance.
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Standard intraoperative monitoring was used for routine anesthetic and analgesic management without NOL index guidance.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Postoperative pain intensity assessed using the Visual Analog Scale (VAS)
大体时间：10 minutes, 30 minutes, 4 hours, 8 hours, 12 hours, and 24 hours after surgery
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Postoperative pain intensity was evaluated using a 10-cm Visual Analog Scale (VAS), where 0 indicated no pain and 10 indicated the worst imaginable pain.
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10 minutes, 30 minutes, 4 hours, 8 hours, 12 hours, and 24 hours after surgery
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Time to first breastfeeding
大体时间：Within the first postoperative hour
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The time elapsed from the end of surgery until the first successful breastfeeding was recorded in minutes.
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Within the first postoperative hour
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Need for rescue analgesia
大体时间：Within the first 24 hours after surgery
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The proportion of patients requiring additional postoperative analgesia was recorded.
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Within the first 24 hours after surgery
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- HASEKI-36-408-2023
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
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