Not Yet RecruitingNot Applicable

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

United States100 participantsStarted 2026-05

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Total opioid requirement during surgery and PACU stay

Timeframe: One day

Trial details

NCT IDNCT07608276

SponsorMedasense Biometrics Ltd

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12

Contact for this trial

Jaime Baratta, MD

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

View on ClinicalTrials.gov More Spine Surgery trials