An Observational Study Measuring in a Non-invasive Approach the Nociception Level Index and Its Association With Pain and Anxieiy Perception Evaluated by Questionnaires, in Awake Women During Elective Cesarean Delivery Under Spinal Anesthesiaanxiety

NCT07726316 | Not Yet Recruiting DMC

• 1 other identifier: 0005-26-CMC
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The Nociception Level (NOL) Index is a multiparametric, non-invasive monitor that objectively assesses nociception by integrating several autonomic physiological signals. Although the NOL Index has been extensively validated during general anesthesia, its performance in awake patients undergoing regional anesthesia remains poorly understood. During cesarean delivery (CD) under spinal anesthesia, autonomic responses may be influenced not only by nociceptive stimulation but also by anxiety, uterine contractions, hemodynamic changes, uterotonic medications, and other non-nociceptive factors. Understanding the relative contribution of these factors is essential before the NOL Index can be reliably applied in awake surgical patients. This prospective observational study aims to characterize the behavior of the NOL Index throughout elective CD performed under spinal anesthesia and to evaluate its relationship with subjective pain intensity, anxiety, uterine activity, perioperative autonomic responses, and routine physiological variables. Approximately 100 women undergoing elective CD under spinal anesthesia will be enrolled at Carmel Medical Center. Continuous NOL monitoring using the PMD-200 system will be performed from before spinal anesthesia until the early postoperative period. Subjective pain (Visual Analog Scale), anxiety (Visual Analog Scale for Anxiety), uterine activity, hemodynamic variables, perioperative medications, and predefined surgical events will be prospectively recorded and synchronized with continuous NOL measurements. Potential confounding factors, including vasopressor administration, uterotonic drugs, nausea, shivering, patient movement, and supplemental analgesia, will also be documented. This study will provide one of the first comprehensive evaluations of continuous NOL monitoring during CD under spinal anesthesia. The results are expected to improve the understanding of objective nociception monitoring in awake patients, clarify the influence of non-nociceptive autonomic activation on the NOL Index, and help define the clinical role and limitations of NOL monitoring during regional anesthesia, and may contribute to the future development of objective pain assessment strategies in obstetric anesthesia and other clinical settings involving awake patients.

Conditions

Cesarean Delivery

Keywords

Cesarean Delivery; Spinal Anesthesia; NOL Index; Nociception; Pain Monitoring;; Obstetric Anesthesia; Anxiety; Uterine Contractions; Autonomic Nervous System

Outcome Measures

Primary Outcomes (1)

• Percentage of intraoperative monitoring time during which the Nociception Level Index remains outside the predefined target range (10-25) during elective cesarean delivery under spinal anesthesia

  Nociception Level Index a physiological parameter measurment obtained, in a non invasive way, by a probe attached to the index finger, recording every 5 seconds. (range 0-100) 0 no pain 100 worst pain

  Intraoperative period up to 3 hours

Secondary Outcomes (6)

• Duration of Nociception Level Index (>25)

  Intraoperative period and approximately 1 hour postoperatively, up to 5 hours

• Correlation between Nociception Level Index and Visual Analog Scale

  : Intraoperative period and approximately 1 hour postoperatively up to 5 hours

• Correlation between Nociception Level Index and Visual Analogue Scale- anxiety

  Intraoperative period and approximately 1 hour postoperatively up to 5 hours

• Surgical phase analysis

  Intraoperative period and approximately 1 hour postoperatively

• Association of Nociception Level Index with uterine activity

  Intraoperative period and approximately 1 hour postoperatively up to 5 hours

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Women ≥18 years, scheduled to elective cesarean delivery under spinal anesthesia
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women ≥18 years, ASA I-III, scheduled to elective cesarean delivery under spinal anesthesia

You may qualify if:

• Women ≥18 years
• Scheduled to elective cesarean delivery under spinal anesthesia
• ASA I-III
• Able to provide informed consent

You may not qualify if:

• Women Age \<18 years
• BMI \>35 kg/m²
• Major psychiatric illness
• Chronic psychotropic/anxiolytic therapy
• Substance abuse
• Inability to communicate
• Contraindication to spinal anesthesia
• Any pre condition interfering with study participation

Sponsors & Collaborators

• Michael Grach: lead

Study Sites (1)

Carmel medical center

Haifa, 3436212, Israel

Location

Related Publications (13)

• Okur, N., Yıldırım, D., & Aydın, E. (2020). Evaluation of preoperative anxiety in pregnant women before elective cesarean section: Comparison of VAS and STAI scales. Journal of Obstetrics and Gynaecology Research, 46(1), 5-10. https://doi.org/10.1111/jog.14126

  BACKGROUND

• Abend, R., Dan, O., Maoz, K., Raz, S., & Bar-Haim, Y. (2014). Reliability, validity and sensitivity of a computerized visual analog scale for anxiety. Cognition and Emotion, 28(8), 1434-1441. https://doi.org/10.1080/02699931.2014.881326

  BACKGROUND

• Andersen T, Sandnes A, Hilland M, Halvorsen T, Fondenes O, Heimdal JH, Tysnes OB, Roksund OD. Laryngeal response patterns to mechanical insufflation-exsufflation in healthy subjects. Am J Phys Med Rehabil. 2013 Oct;92(10):920-9. doi: 10.1097/PHM.0b013e3182a4708f.

  PMID: 24051994 BACKGROUND

• Witteveen, A. B. et al. (2019). "Postpartum PTSD and its risk factors following emergency cesarean delivery." Arch Womens Ment Health, 22, 229-237. https://doi.org/10.1007/s00737-018-0918-5

  BACKGROUND

• Fentie Y, Yetneberk T, Gelaw M. Preoperative anxiety and its associated factors among women undergoing elective caesarean delivery: a cross-sectional study. BMC Pregnancy Childbirth. 2022 Aug 17;22(1):648. doi: 10.1186/s12884-022-04979-3.

  PMID: 35978308 BACKGROUND

• 8. Sessler, D. I., & Devereaux, P. J. (2021).*Perioperative anesthetic management and long-term outcomes*. Anesthesiology, 134(5), 698-713. https://doi.org/10.1097/ALN.0000000000003707

  BACKGROUND

• 7. Edry, R., Recea, V., Dikust, Y., Sessler, D. I., & Ezri, T. (2016). *Preliminary intraoperative evaluation of a novel nociception monitor in patients undergoing abdominal surgery*. British Journal of Anaesthesia, 117(4), 477-483. https://doi.org/10.1093/bja/aew223

  BACKGROUND

• Meijer, F., Honing, M., Bom, A., Kalmar, A., Martini, C., & Struys, M. (2020). *Nociception-guided versus standard opioid administration during general anaesthesia: A meta-analysis of randomized controlled trials*. British Journal of Anaesthesia, 124(4), 474-483. https://doi.org/10.1016/j.bja.2019.12.034

  BACKGROUND

• Van Driessche, F., Cromheecke, S., De Hert, S., & Rex, S. (2020). NOL-guided opioid administration during general anesthesia for cesarean section: A feasibility study. BMC Anesthesiology, 20, Article 80. https://doi.org/10.1186/s12871-020-01026-0

  BACKGROUND

• Martini CH, Boon M, Broens SJ, Hekkelman EF, Oudhoff LA, Buddeke AW, Dahan A. Ability of the nociception level, a multiparameter composite of autonomic signals, to detect noxious stimuli during propofol-remifentanil anesthesia. Anesthesiology. 2015 Sep;123(3):524-34. doi: 10.1097/ALN.0000000000000757.

  PMID: 26154185 BACKGROUND

• Meijer FS, Martini CH, Broens S, Boon M, Niesters M, Aarts L, Olofsen E, van Velzen M, Dahan A. Nociception-guided versus Standard Care during Remifentanil-Propofol Anesthesia: A Randomized Controlled Trial. Anesthesiology. 2019 May;130(5):745-755. doi: 10.1097/ALN.0000000000002634.

  PMID: 30829658 BACKGROUND

• Edry R, Recea V, Dikust Y, Sessler DI. Preliminary Intraoperative Validation of the Nociception Level Index: A Noninvasive Nociception Monitor. Anesthesiology. 2016 Jul;125(1):193-203. doi: 10.1097/ALN.0000000000001130.

  PMID: 27171828 BACKGROUND

• Ben-Israel N, Kliger M, Zuckerman G, Katz Y, Edry R. Monitoring the nociception level: a multi-parameter approach. J Clin Monit Comput. 2013 Dec;27(6):659-68. doi: 10.1007/s10877-013-9487-9. Epub 2013 Jul 9.

  PMID: 23835792 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

Michael Grach, MD Dr.

CONTACT

+972506265753; Grachm@gmail.com

Dana Kosh, MD Dr.

CONTACT

972- 4-8250785; Danako@clalit.org.il

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD Dr. Michael Grach Director of pain medicine clinic

Study Record Dates

• First Submitted: July 11, 2026
• First Posted: July 24, 2026
• Study Start (Estimated): August 15, 2026
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): July 30, 2027
• Last Updated: July 24, 2026

Record last verified: 2026-07

Locations

IL (1)