Nociception Level Index Monitoring During Cesarean Section

NCT07720440 | Completed

• 1 other identifier: HASEKI-36-408-2023
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cesarean Section; Postoperative Pain After Cesarean Section; Pain Management

Keywords

Nociception Level Index; NOL Index; Intraoperative Analgesia; Cesarean Section; General Anesthesia; Postoperative Pain; Opioid Consumption; Breastfeeding; Nociception Monitoring

Outcome Measures

Primary Outcomes (1)

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

  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.

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

Secondary Outcomes (1)

• Time to first breastfeeding

  Within the first postoperative hour

Other Outcomes (1)

• Need for rescue analgesia

  Within the first 24 hours after surgery

Study Arms (2)

NOL-Guided Analgesia Group

EXPERIMENTAL

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.

Device: Nociception Level Index Monitoring

Standard Monitoring Group

ACTIVE COMPARATOR

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.

Other: Standard Intraoperative Monitoring

Interventions

Standard Intraoperative Monitoring OTHER

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

Standard Monitoring Group

Nociception Level Index Monitoring DEVICE

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

NOL-Guided Analgesia Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients undergoing elective cesarean section under general anesthesia.
• Ability to provide written informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istinye University: lead

Study Sites (1)

University of Health Sciences Türkiye Haseki Training and Research Hospital

Istanbul, Sultangazi, 34256, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Agnosia; Pain, Postoperative; Breast Feeding

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain; Feeding Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc.Prof

Model Details: Participants were randomly assigned in a 1:1 ratio to either a Nociception Level (NOL) index-guided analgesia group or a standard intraoperative monitoring group. Both groups underwent elective cesarean section under general anesthesia using the same anesthetic protocol. In the intervention group, fentanyl administration after fetal delivery was guided by the NOL index, whereas in the control group analgesia was managed according to conventional clinical practice based on standard hemodynamic monitoring.

Study Record Dates

• First Submitted: July 18, 2026
• First Posted: July 22, 2026
• Study Start: August 15, 2023
• Primary Completion: February 15, 2024
• Study Completion: February 15, 2024
• Last Updated: July 22, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)