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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Spine Surgery; Anesthesia , Analgesia; Pain After Surgery
• Intervention / Treatment: Device: NOL guided intraoperative analgesia

Detailed Description

The study will assess the impact of intraoperative use of NOL nociception monitoring in in-hospital spine surgery procedures performed under general anesthesia on post operative patient outcomes. The study is designed as a quality improvement project with the prospective outcomes to be compared to a retrospective matched cohort. The objective of this study is to evaluate the clinical impact of the device 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. The clinical impact will also be translated into economic metrics.

Secondary endpoints

1. Reduction in time to extubation
2. Reduction in time to PACU discharge readiness

3. Reduction in anesthesia related adverse events:

   1. PONV
   2. Respiratory depression defined as respiratory rate (RR) below 8 respirations per minute (RPM) for 1 minute. Saturation of less than 90% for 1 minute under continuous monitoring
   3. Somnolence
   4. Sedation (Pasero score)
   5. Discharge readiness (modified Aldrete score)
   6. PACU pain intensity (NRS pain intensity ratings measured according to SOC) 6.3 Exploratory endpoints

INTRAOPERATIVE

1. Reduction in hemodynamic instability (hypertension, hypotensive events)
2. Use of vasoactive medication (ephedrine, phenylephrine, norepinephrine, atropine)
3. Association between time spent with NOL values above 25 and PACU pain intensity ratings

WARD - up to 48 hours post surgery

1. Patient reported satisfaction levels using questionnaire QR15
2. Pain intensity (Time points: NRS according to the SOC))
3. 48 hours post-operative opioid consumption
4. Requirement for Acute Pain Service consultation
5. Reduction in rescue opioid requirements
6. Ketamine prescription on the ward
7. Opioid prescription on the ward
8. PONV medication consumption
9. Clinician survey on the device

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jaime Baratta, MD; Phone Number: 215-955-6161; Email: jaime.baratta@jefferson.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University Hospital
      • Contact: Jaime Baratta, MD; Phone Number: 215-955-6161; Email: jaime.baratta@jefferson.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• • 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Retrospective cohort; A retrospective arm will be case matched from the hospital's EMR system.

Device: NOL guided intraoperative analgesia; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total opioid requirement during surgery and PACU stay	Total opioid requirement during surgery and PACU stay reported in morphine equivalents (mgs)	One day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in time to extubation	Reduction in time to extubation measured in minutes	one day
Reduction in time to PACU discharge readiness	Reduction in time to PACU discharge readiness measured in minutes	one day
Modified Aldrete Score	Modified Aldrete Score (scale of 0-10)	one day
Reduction in PACU pain intensity rating	Reduction in PACU pain intensity rating (NRS scale of 0-10 )	one day
Anesthesia Related Adverse Events - PONV	PONV in PACU assessed used accepted PONV symptom scale (0-4)	1 day
Anesthesia Related Adverse Events in PACU - Respiratory Depression	Respiratory depression defined as respiratory rate (RR) below 8 respirations per minute (RPM) for 1 minute. Saturation of less than 90% for 1 minute under continuous monitoring	one day
Anesthesia Related Adverse Events in PACU - Sedation & Somnolence	Sedation & Somnolence using Pasero Scale (S 1-4)	one day

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ward recovery metrics - patient satisfaction levels	Patient reported satisfaction levels using standard QoR15 questionnaire responses in the NOL arm only	three days
Intraoperative metrics - Hemodynamic instability	Reduction in hemodynamic instability (hypertensive are MAP above 120mmHg, hypotensive events are MAP below 65mmHg)	One day
Intraoperative metrics - vasocative medication requirement	Use of vasoactive medication (ephedrine, phenylephrine, norepinephrine, atropine) total doses in mgs.	One day
Ward recovery metrics - Pain Intensity	Pain intensity. Time points: NRS pain score on a scale of 0-10 , measurement frequency per hospital standard of care.	three days
Intraoperative metrics - nociception levels during surgery	Correlation between time spent with NOL values above 25 (range 0-100 no unit of measurement) and PACU pain intensity ratings measured using the NRS scale (0-10) - to be assessed in the NOL arm only	One day
Ward recovery metrics - post operative opioid consumption	48 hours post-operative opioid consumption measured in morphine equivalents in mgs.	three days
Ward recovery metrics - Requirement for Acute Pain Service consultation	Requirement for Acute Pain Service consultation (Y/N)	three days
Ward recovery metrics - reduction in rescue opioid requirements	Reduction in rescue opioid requirements - morphine equivalents in mgs	three days
Ward recovery metrics - Ketamine requirement	Ketamine prescription on the ward (mgs)	three days
Ward recovery metrics - Opioid requirement on the ward	number of opioid prescriptions and total amount in morphine equivalents (mgs)	three days
Ward recovery metrics - PONV	PONV medication consumption in mgs	three days

Collaborators and Investigators

• Sponsor: Medasense Biometrics Ltd
• Collaborators: Thomas Jefferson Health

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: May 5, 2026
• First Submitted That Met QC Criteria: May 20, 2026
• First Posted (Actual): May 27, 2026

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: pain; quality improvement; nociception; NOL nociception level index
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neurobehavioral Manifestations; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Agnosia
• Other Study ID Numbers: NOL Monitoring Spine Surgery

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is a pilot project and we have not envisioned working wth other centers on this project.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No