Nociception Level Index Monitoring During Cesarean Section (NOL-CS)
Effect of Nociception Level Index-Guided Intraoperative Analgesia on Postoperative Pain Management During Elective Cesarean Section
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Sultangazi
-
Istanbul, Sultangazi, Turkiet (Türkiye), 34256
- University of Health Sciences Türkiye Haseki Training and Research Hospital
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
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.
|
Standard intraoperative monitoring was used for routine anesthetic and analgesic management without NOL index guidance.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Postoperative pain intensity assessed using the Visual Analog Scale (VAS)
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Time to first breastfeeding
Tidsram: 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
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Need for rescue analgesia
Tidsram: Within the first 24 hours after surgery
|
The proportion of patients requiring additional postoperative analgesia was recorded.
|
Within the first 24 hours after surgery
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- HASEKI-36-408-2023
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Kejsarsnitt
-
Shanghai First Maternity and Infant HospitalOkändCesarean Scar DiverticulaKina
-
Xipeng WangOkändCesarean Scar DiverticulaKina
-
Kantonsspital BadenHar inte rekryterat ännuCesarean Scar Diverticula | IsthmoceleSchweiz
Kliniska prövningar på Nociception Level Index Monitoring
-
Centre Hospitalier Universitaire de Saint EtienneAvslutadSmärta | Alzheimers sjukdom | Autonoma nervsystemets sjukdomFrankrike
-
McGill UniversityMaisonneuve-Rosemont Hospital; Jewish General HospitalHar inte rekryterat ännuKritisk sjukdom | Smärta, Akut | Beteende | Nociceptiv smärta
-
Universitätsklinikum Hamburg-EppendorfRekryteringSmärta, postoperativt | Opioidanvändning | Nociceptiv smärta | Återhämtningstid för anestesi | Analgesi, postoperativTyskland
-
Haseki Training and Research HospitalAvslutadAnestesi, general | Intensivvård, KirurgiskKalkon
-
University Hospital, BordeauxAvslutadVätskelyhördhet | VolymexpansionFrankrike
-
Leiden University Medical CenterRekryteringNociceptiv smärtaNederländerna
-
Investigation Group Anesthesia, Resuscitation,...RekryteringSkörhet i vuxenkirurgiSpanien
-
Assistance Publique - Hôpitaux de ParisURC-CIC Paris Descartes Necker CochinAvslutadKvalificerad för dagfallskirurgiFrankrike
-
İstanbul Yeni Yüzyıl ÜniversitesiHar inte rekryterat ännuSmärta | Intensivvårdsavdelningens syndrom | Stressrelaterad störning
-
University Hospital, LilleClinical Investigation Centre for Innovative Technology Network; Fondation...AvslutadSmärta | Cerebral pares | BarnFrankrike