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Completed

NCT Number: NCT07720440

Nociception Level Index Monitoring During Cesarean Section

This prospective randomized controlled trial evaluated the effect of nociception level (NOL) index-guided intraoperative analgesia on postoperative pain management in patients undergoing elective cesarean section under general anesthesia. Sixty patients were randomly assigned to either NOL-guided analgesia or standard intraoperative monitoring. The primary outcome was postoperative pain intensity assessed using the visual analog scale (VAS) during the first 24 hours after surgery. Secondary outcomes included postoperative opioid requirements and time to first breastfeeding. The study aimed to determine whether objective intraoperative nociception monitoring could improve postoperative analgesia and enhance early maternal recovery.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Health Sciences Türkiye Haseki Training and Research Hospital

Istanbul, Sultangazi, 34256, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Nociception Level Index Monitoring

Device

The Nociception Level (NOL) index was used to guide intraoperative fentanyl administration after fetal delivery.

Standard Intraoperative Monitoring

Other

Standard intraoperative monitoring was used for routine anesthetic and analgesic management without NOL index guidance.

Primary outcomes

  1. Postoperative pain intensity assessed using the Visual Analog Scale (VAS)

    Time frame: 10 minutes, 30 minutes, 4 hours, 8 hours, 12 hours, and 24 hours after surgery

    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.

Secondary outcomes

  1. Time to first breastfeeding

    Time frame: Within the first postoperative hour

    The time elapsed from the end of surgery until the first successful breastfeeding was recorded in minutes.

Other outcomes

  1. Need for rescue analgesia

    Time frame: Within the first 24 hours after surgery

    The proportion of patients requiring additional postoperative analgesia was recorded.

Sponsors and collaborators

Lead sponsor

Istinye University

Other

Registry information

Official study title

Effect of Nociception Level Index-Guided Intraoperative Analgesia on Postoperative Pain Management During Elective Cesarean Section

Acronym: NOL-CS

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 22, 2026
Registry last updated
Jul 22, 2026

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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