NOL Nociception Level Index Monitoring for Spine Surgery

This study is looking at how using a special monitor, called the PMD-200 with the NOL index, during spine surgery affects patients. The monitor helps doctors decide how much pain medicine (analgesia) to give during surgery. The goal is to see if using this monitor can reduce the total amount of opioid pain medicine needed during and right after surgery, and improve recovery. You might be able to join if you are over 18, having elective spine surgery (like laminectomy or spinal fusion) under general anesthesia, and meet other health criteria. The study is comparing outcomes for patients who use the monitor to those who didn't in the past.

Study design
This is a quality improvement project comparing patients who receive NOL-guided analgesia during spine surgery to a group of similar patients from the past. About 100 people are planned to be included in the study.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome of total opioid requirement will be measured one day after surgery.

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NCT07608276

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

Not Yet Recruiting
NAAges 18+InterventionalTreatment
Medasense Biometrics Ltd
~100 participants
Updated 2026-05-27 on ClinicalTrials.gov
What's tested:NOL guided intraoperative analgesia

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Total opioid requirement during surgery and PACU stay
Measured over One day
Spine Surgery
Pain After Surgery
Anesthesia , Analgesia
1 sites across 1 states
Pennsylvania1

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Eligibility criteria

Inclusion

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

• 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)
  • Total opioid requirement during surgery and PACU stayOne day

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