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NCT07720440

Overview

NCT ID: NCT07720440
Lead Sponsor: Istinye UniversityOTHER
Official Title: Effect of Nociception Level Index-Guided Intraoperative Analgesia on Postoperative Pain Management During Elective Cesarean Section
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

Status and Timeline

Status: Completed
Last Update Posted: Jul 22, 2026Actual
Start Date: Aug 15, 2023Actual
Primary Completion Date: Feb 15, 2024Actual
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: Female
Accepts Healthy Volunteers?: No
Eligibility Criteria: 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.

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 60Actual
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Contacts and Locations

Central Contacts: No data available
Locations: University of Health Sciences Türkiye Haseki Training and Research Hospital

Similar Studies

Participant Group/Arms

NOL-Guided Analgesia GroupExperimental

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 GroupActive 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