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New pain monitor aims to cut opioid use in spine surgery

NCT ID NCT07608276

Symptom relief Sponsor: Medasense Biometrics Ltd Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This pilot study tests a device called the NOL monitor, which measures pain levels during spine surgery. Doctors use it to decide when to give more pain medicine. The goal is to see if this approach reduces the amount of opioids needed during and after surgery, and helps patients wake up and leave the recovery room faster. About 100 adults having elective spine surgery will take part.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
PMD-200 monitor with NOL index (device)
What this could lead to
If it works, this could help doctors give just the right amount of pain medicine during surgery, possibly reducing side effects and speeding up recovery.
What could go wrong
This is a small pilot study with only 100 people, and it compares results to past cases rather than a control group. The device may not improve outcomes significantly.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

agnosia Pain

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anesthesia , analgesia Pain after surgery Spine surgery

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107, United States

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