Cesarean Section, Pain Management, Postoperative Pain After Cesarean Section
Conditions
Keywords
Nociception Level Index, NOL Index, Intraoperative Analgesia, Cesarean Section, General Anesthesia, Postoperative Pain, Opioid Consumption, Breastfeeding, Nociception Monitoring
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.
Detailed description
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.
Interventions
DEVICENociception Level Index Monitoring
The Nociception Level (NOL) index was used to guide intraoperative fentanyl administration after fetal delivery.
OTHERStandard Intraoperative Monitoring
Standard intraoperative monitoring was used for routine anesthetic and analgesic management without NOL index guidance.
Sponsors
Istinye University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain intensity assessed using the Visual Analog Scale (VAS) | 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
| Measure | Time frame | Description |
|---|---|---|
| Time to first breastfeeding | Within the first postoperative hour | The time elapsed from the end of surgery until the first successful breastfeeding was recorded in minutes. |
Countries
Turkey (Türkiye)
Outcome results
None listed