Spine SurgeryNCT07608276
Impact of NOL - Nociception Level Index Intraoperative Monitoring on Perioperative Outcomes in Spine Surgery - a Quality Improvement Pilot
A study testing NOL guided intraoperative analgesia in people with Spine Surgery and Pain After Surgery, run by Medasense Biometrics Ltd at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spine Surgery, Pain After Surgery, Anesthesia , Analgesia
- What is being tested?
- NOL guided intraoperative analgesia
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- May 2026to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- • 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)
Show all 9Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Jaime Baratta, MD, 215-955-6161, jaime.baratta@jefferson.edu
About this study
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.
Read the 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
- Reduction in time to extubation
- Reduction in time to PACU discharge readiness
- Reduction in anesthesia related adverse events:
- PONV
- 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
- Somnolence
- Sedation (Pasero score)
- Discharge readiness (modified Aldrete score)
- PACU pain intensity (NRS pain intensity ratings measured according to SOC) 6.3 Exploratory endpoints
INTRAOPERATIVE
- Reduction in hemodynamic instability (hypertension, hypotensive events)
- Use of vasoactive medication (ephedrine, phenylephrine, norepinephrine, atropine)
- Association between time spent with NOL values above 25 and PACU pain intensity ratings
WARD - up to 48 hours post surgery
- Patient reported satisfaction levels using questionnaire QR15
- Pain intensity (Time points: NRS according to the SOC))
- 48 hours post-operative opioid consumption
- Requirement for Acute Pain Service consultation
- Reduction in rescue opioid requirements
- Ketamine prescription on the ward
- Opioid prescription on the ward
- PONV medication consumption
- Clinician survey on the device
- Conditions
- Spine Surgery, Pain After Surgery, Anesthesia , Analgesia
- Being tested
- NOL guided intraoperative analgesia
- Keywords
- nociception, pain, NOL nociception level index, quality improvement
- Medical subject headings
- Agnosia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NOL guided intraoperative analgesiaDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Retrospective cohort | Other | A retrospective arm will be case matched from the hospital's EMR system. Receives: Device: NOL guided intraoperative analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total opioid requirement during surgery and PACU stay
Total opioid requirement during surgery and PACU stay reported in morphine equivalents (mgs)
Measured: One day
Secondary outcomes (7)
Reduction in time to extubation
Reduction in time to extubation measured in minutes
Measured: one day
Reduction in time to PACU discharge readiness
Reduction in time to PACU discharge readiness measured in minutes
Measured: one day
Modified Aldrete Score
Modified Aldrete Score (scale of 0-10)
Measured: one day
Reduction in PACU pain intensity rating
Reduction in PACU pain intensity rating (NRS scale of 0-10 )
Measured: one day
Anesthesia Related Adverse Events - PONV
PONV in PACU assessed used accepted PONV symptom scale (0-4)
Measured: 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
Measured: one day
Anesthesia Related Adverse Events in PACU - Sedation & Somnolence
Sedation \& Somnolence using Pasero Scale (S 1-4)
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2026
- Study startMay 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Spine SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medasense Biometrics Ltd
- Sponsor type
- University, hospital or other
- Collaborators
- Thomas Jefferson Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07608276
- Sponsor's protocol ID
- NOL Monitoring Spine Surgery
- Status last verified
- May 2026
- First submitted
- 5 May 2026
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: This is a pilot project and we have not envisioned working wth other centers on this project.
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.
PubMed 30829658Khalaila 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.
PubMed 41464862
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of NOL - Nociception Level Index Intraoperative Monitoring on Perioperative Outcomes in Spine Surgery - a Quality Improvement Pilot
- ClinicalTrials.gov ID
- NCT07608276
- Acronym / sponsor ID
- NOL Monitoring Spine Surgery
- Conditions
- Spine Surgery, Pain After Surgery, Anesthesia , Analgesia
- Keywords
- nociception, pain, NOL nociception level index, quality improvement
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Medasense Biometrics LtdUniversity, hospital or other
- Collaborators
- Thomas Jefferson Health
- Study start
- May 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 27 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Reduction in time to extubation
- Reduction in time to PACU discharge readiness
- Reduction in anesthesia related adverse events:
- PONV
- 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
- Somnolence
- Sedation (Pasero score)
- Discharge readiness (modified Aldrete score)
- PACU pain intensity (NRS pain intensity ratings measured according to SOC) 6.3 Exploratory endpoints
INTRAOPERATIVE
- Reduction in hemodynamic instability (hypertension, hypotensive events)
- Use of vasoactive medication (ephedrine, phenylephrine, norepinephrine, atropine)
- Association between time spent with NOL values above 25 and PACU pain intensity ratings
WARD - up to 48 hours post surgery
- Patient reported satisfaction levels using questionnaire QR15
- Pain intensity (Time points: NRS according to the SOC))
- 48 hours post-operative opioid consumption
- Requirement for Acute Pain Service consultation
- Reduction in rescue opioid requirements
- Ketamine prescription on the ward
- Opioid prescription on the ward
- PONV medication consumption
- Clinician survey on the device
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Retrospective cohort | Other | Device: NOL guided intraoperative analgesiaA retrospective arm will be case matched from the hospital's EMR system. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- • Use of any type of anesthesia other than general anesthesia (neuraxial, epidural analgesia or local regional anesthesia)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NOL guided intraoperative analgesiaThe 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. | Device | Retrospective cohort |
Primary outcome
Total opioid requirement during surgery and PACU stay
Time frame: One day
Total opioid requirement during surgery and PACU stay reported in morphine equivalents (mgs)
7 secondary outcomes
Reduction in time to extubation
Time frame: one day
Reduction in time to PACU discharge readiness
Time frame: one day
Modified Aldrete Score
Time frame: one day
Reduction in PACU pain intensity rating
Time frame: one day
Anesthesia Related Adverse Events - PONV
Time frame: 1 day
Anesthesia Related Adverse Events in PACU - Respiratory Depression
Time frame: one day
Anesthesia Related Adverse Events in PACU - Sedation & Somnolence
Time frame: one day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Background: PubMed 30829658Meijer 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.
- Background: PubMed 41464862Khalaila 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. This is a pilot project and we have not envisioned working wth other centers on this project.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NOL guided intraoperative analgesia in people with Spine Surgery and Pain After Surgery, run by Medasense Biometrics Ltd at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jaime Baratta, MD (215-955-6161, Jaime.Baratta@jefferson.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total opioid requirement during surgery and PACU stay (time frame: One day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07608276, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.