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Pain monitor aims to cut opioid use during surgery

NCT ID NCT04402242

Knowledge-focused Sponsor: Hopital Foch 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
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a device called the NOL monitor, which measures pain levels during anesthesia. The goal was to see if using this monitor could help doctors give less remifentanil (a strong painkiller) during major abdominal surgery. The study planned to include 90 adults, but it was stopped early, so the results are not complete.

What this could mean

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

What this could lead to
If successful, this could show that NOL monitoring helps tailor pain medication during surgery, potentially reducing side effects.
What could go wrong
The study was terminated early, so we don't have enough data to know if it works. It was also a small, single-center trial.

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

90 people

The number who actually took part.

Started

Apr 2021

Finished

Jul 2023

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 * American Society of Anesthesiologists score (ASA) I, II or III stable * Laparotomy or laparoscopy for major, planned, digestive, urological or gynecological surgery under total intravenous anesthesia (expected total duration \> 90 minutes) * Having sign an informed consent form prior to any study specific procedure * Being covered by a national health insurance Non-Inclusion Criteria: * Pregnancy/lactation * Patient with antiarrhythmic agents * Patient with Central nervous system disorder * Patient with veinous approach difficulties * Patient at risk of difficult mask ventilation or difficult intubation * Concomitant use of any type of anesthesia other than general anesthesia (epidural anesthesia, spinal anesthesia, wall block, pericatricial infiltration). Wall blocks and pericatricial infiltrations are allowed if they are carried out at the end of the intervention * Allergy or intolerance to any of the study drugs * Patient not understanding French language * Being deprived of liberty or under guardianship Exclusion Criteria: * Patient requiring the administration of succinylcholine * Patient with hemodynamic abnormality just before induction of anesthesia (mean arterial pressure \< 65 mm Hg or \> 110 mm Hg, heart rate \< 45/min or \> 90/min * Concomitant use of any type of anesthesia other than general anesthesia (epidural anesthesia, spinal anesthesia, wall block, pericatricial infiltration). Wall blocks and pericatricial infiltrations are allowed if they are carried out at the end of the intervention * Concomitant use of IV lidocaine or continuous ketamine (IV, SE) during anaesthesia

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As listed by the trial registrant

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

Abdominal surgery

Contacts and locations

Locations

  • Foch Hospital

    Suresnes, France, 92150, France

  • Hopital d'Instruction des Armées de Bégin

    Saint-Mandé, Saint Mandé, 94160, France

  • Hôpital d'Instruction des Armées - Sainte-Anne

    Toulon, Provence-Alpes-Côte d'Azur Region, 83800, France

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