Cesarean SectionNOL-CSNCT07720440
Nociception Level Index Monitoring During Cesarean Section
A study testing Nociception Level Index Monitoring and Standard Intraoperative Monitoring in people with Cesarean Section and Postoperative Pain After Cesarean Section, run by Istinye University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cesarean Section, Postoperative Pain After Cesarean Section, Pain Management
- What is being tested?
- Nociception Level Index Monitoring and Standard Intraoperative Monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Aug 2023to 15 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients undergoing elective cesarean section under general anesthesia.
- Ability to provide written informed consent.
Who cannot join
- 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.
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- Alcohol or substance abuse.
- Severe cardiac disease or severe arrhythmia.
- Peripheral vascular disease.
- Renal or hepatic failure.
- Contraindication to corticosteroid administration.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences Türkiye Haseki Training and Research Hospital
Istanbul, Sultangazi, 34256
About this study
Official title: Effect of Nociception Level Index-Guided Intraoperative Analgesia on Postoperative Pain Management During Elective 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.
Read the 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.
- Being tested
- Nociception Level Index Monitoring, Standard Intraoperative Monitoring
- Keywords
- Nociception Level Index, NOL Index, Intraoperative Analgesia, Cesarean Section, General Anesthesia, Postoperative Pain, Opioid Consumption, Breastfeeding, Nociception Monitoring
- Medical subject headings
- Agnosia, Pain, Postoperative, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nociception Level Index MonitoringDevice
The Nociception Level (NOL) index was used to guide intraoperative fentanyl administration after fetal delivery.
Standard Intraoperative MonitoringOther
Standard intraoperative monitoring was used for routine anesthetic and analgesic management without NOL index guidance.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standard Intraoperative Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 minutes, 30 minutes, 4 hours, 8 hours, 12 hours, and 24 hours after surgery
Secondary outcomes (1)
Time to first breastfeeding
The time elapsed from the end of surgery until the first successful breastfeeding was recorded in minutes.
Measured: Within the first postoperative hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study start15 Aug 2023
- Primary completion15 Feb 2024
- Study completion15 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean SectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İlke Dolgun, Istinye University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07720440
- Sponsor's protocol ID
- HASEKI-36-408-2023
- Acronym
- NOL-CS
- Status last verified
- Jul 2026
- First submitted
- 18 Jul 2026
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Nociception Level Index-Guided Intraoperative Analgesia on Postoperative Pain Management During Elective Cesarean Section
- ClinicalTrials.gov ID
- NCT07720440
- Acronym / sponsor ID
- NOL-CS / HASEKI-36-408-2023
- Keywords
- Nociception Level Index, NOL Index, Intraoperative Analgesia, Cesarean Section, General Anesthesia, Postoperative Pain, Opioid Consumption, Breastfeeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 15 Aug 2023 (actual)
- Primary completion
- 15 Feb 2024 (actual)
- Study completion
- 15 Feb 2024 (actual)
- First posted
- 22 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| NOL-Guided Analgesia Group | Experimental | Device: Nociception Level Index MonitoringPatients 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. |
| Standard Monitoring Group | Active comparator | Other: Standard Intraoperative MonitoringPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Female patients undergoing elective cesarean section under general anesthesia.
- Ability to provide written informed consent.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nociception Level Index MonitoringThe Nociception Level (NOL) index was used to guide intraoperative fentanyl administration after fetal delivery. | Device | NOL-Guided Analgesia Group |
| Standard Intraoperative MonitoringStandard intraoperative monitoring was used for routine anesthetic and analgesic management without NOL index guidance. | Other | Standard Monitoring Group |
Primary outcome
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.
1 secondary outcome
Time to first breastfeeding
Time frame: Within the first postoperative hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nociception Level Index Monitoring and Standard Intraoperative Monitoring in people with Cesarean Section and Postoperative Pain After Cesarean Section, run by Istinye University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.