Impact of NOL - Nociception Level Index Intraoperative Monitoring on Perioperative Outcomes in Spine Surgery - a Quality Improvement Pilot

NCT07608276 | Not Yet Recruiting FDA Device

• 1 other identifier: NOL Monitoring Spine Surgery
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to evaluate the clinical impact of the NOL nociception level index monitoring on intraoperative and post operative patient outcomes and institutional metrics when used to guide intraoperative analgesia dosing in patients undergoing spine surgery under general anesthesia when compared to a case controlled retrospective cohort.

Conditions

Spine Surgery; Pain After Surgery; Anesthesia , Analgesia

Keywords

nociception; pain; NOL nociception level index; quality improvement

Outcome Measures

Primary Outcomes (1)

• Total opioid requirement during surgery and PACU stay

  Total opioid requirement during surgery and PACU stay reported in morphine equivalents (mgs)

  One day

Secondary Outcomes (7)

• Reduction in time to extubation

  one day

• Reduction in time to PACU discharge readiness

  one day

• Modified Aldrete Score

  one day

• Reduction in PACU pain intensity rating

  one day

• Anesthesia Related Adverse Events - PONV

  1 day

Other Outcomes (11)

• Ward recovery metrics - patient satisfaction levels

  three days

• Intraoperative metrics - Hemodynamic instability

  One day

• Intraoperative metrics - vasocative medication requirement

  One day

Study Arms (1)

Retrospective cohort

OTHER

A retrospective arm will be case matched from the hospital's EMR system.

Device: NOL guided intraoperative analgesia

Interventions

NOL guided intraoperative analgesia DEVICE

The PMD-200 monitor with the NOL index will be used to guide analgesia dosing during anesthesia maintenance as an adjunct monitor used alongside other anesthesia monitors. If the NOL value is above 25 for sixty seconds or more, clinicians will evaluate whether more analgesia is needed. If the NOL value is below 25 the patient is considered to have adequately managed nociception.

Retrospective cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years old.
• ASA I-III
• Elective spine surgery (laminectomy, spinal fusion, and disc replacement) under general anesthesia.
• Opioid tolerant and patients with documented chronic pain may be included
• Patient able to provide informed consent

You may not qualify if:

• Use of any type of anesthesia other than general anesthesia (neuraxial, epidural analgesia or local regional anesthesia)
• Use of intraoperative methadone
• Non-sinus heart rate
• Pregnancy/lactation
• Chronic use of psychoactive drugs within 90 days prior to surgery
• Patients currently using IV opioids (IV drug abuse)
• Allergy or intolerance to any of the study anesthesia related drugs
• History of severe cardiac arrhythmias within the last 12 months
• Surgeries less than 1.5 hours (from incision to extubation)

Sponsors & Collaborators

• Medasense Biometrics Ltd: lead
• Thomas Jefferson Health: collaborator

Study Sites (1)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (2)

• 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

• Khalaila A, Hasan M, Berkovich Y, Sleiman A, Mangoubi E, Grach M, Ibrahim U, Gutman Tirosh A, Shpigelman D, Shpigelman A. Intraoperative Nociception Monitoring Using the NoL Index: Phase-Specific Assessment of Nociceptive Responses During Spinal Surgery. J Clin Med. 2025 Dec 18;14(24):8960. doi: 10.3390/jcm14248960.

  PMID: 41464862 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Agnosia; Pain

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jaime Baratta, MD

CONTACT

215-955-6161; Jaime.Baratta@jefferson.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2026
• First Posted: May 27, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: May 27, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)