Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Nociception Level Index Monitoring During Cesarean Section (NOL-CS)

18. juli 2026 opdateret af: İlke Dolgun, Istinye University

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

60

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Tyrkiet (Türkiye)
    • Sultangazi
      • Istanbul, Sultangazi, Tyrkiet (Türkiye), 34256
        • University of Health Sciences Türkiye Haseki Training and Research Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: NOL-Guided Analgesia Group
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.
Enhed: Nociception Level Index Monitoring
The Nociception Level (NOL) index was used to guide intraoperative fentanyl administration after fetal delivery.
Aktiv komparator: Standard Monitoring Group
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.
Andet: Standard Intraoperative Monitoring
Standard intraoperative monitoring was used for routine anesthetic and analgesic management without NOL index guidance.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Postoperative pain intensity assessed using the Visual Analog Scale (VAS)
Tidsramme: 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.
10 minutes, 30 minutes, 4 hours, 8 hours, 12 hours, and 24 hours after surgery

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Time to first breastfeeding
Tidsramme: Within the first postoperative hour
The time elapsed from the end of surgery until the first successful breastfeeding was recorded in minutes.
Within the first postoperative hour

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Need for rescue analgesia
Tidsramme: Within the first 24 hours after surgery
The proportion of patients requiring additional postoperative analgesia was recorded.
Within the first 24 hours after surgery

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Istinye University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

15. august 2023

Primær færdiggørelse (Faktiske)

15. februar 2024

Studieafslutning (Faktiske)

15. februar 2024

Datoer for studieregistrering

Først indsendt

18. juli 2026

Først indsendt, der opfyldte QC-kriterier

18. juli 2026

Først opslået (Faktiske)

22. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • HASEKI-36-408-2023

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Kejsersnit

Kliniske forsøg med Nociception Level Index Monitoring

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Benin

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner